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Cosmetics Supply Chain Transparency for Business Value and Opportunity

Posted on August 29, 2022August 4, 2023 by rfxadmin

Today, we’re looking at what cosmetics supply chain transparency means, why it matters, and how cosmetic companies can achieve it through the use of technology and gain much more than just a healthier bottom line.

Cosmetics supply chain transparency vs. traceability

Cosmetics supply chain transparency means the whole supply chain is visible, from raw materials, production, and packaging to delivery to retailers and, ultimately, consumers. A lack of transparency in complex supply chains that move billions of products can cause significant risks to both consumer and product owner.

Transparency results from creating a full, shareable, fact-based profile of every aspect of the supply chain. It is a means for companies to support its claims (e.g., product provenance, sustainability, ethical sourcing) and tell the world, “We are what we say we are.” In this way, transparency is a strategic concept — one more and more cosmetic companies are adopting because of its significant benefits for operational efficiency, consumer engagement, brand protection, and profitability.

Traceability most often concerns individual products and aggregations (e.g., boxes, cartons, pallets) and observing/monitoring them as they make their way through the supply chain. It is a means to identify, follow, and verify what’s in your supply chain, as well as comply with regulations that mandate traceability through serialization and digitalization.

Cosmetics supply chain transparency for business value

It’s the global cosmetics market will grow from $287.94 billion in 2021 to $415.29 billion in 2028. Indeed, there are signs the market is booming. For example, L’Oréal, the world’s largest beauty brand, reported record profits last year, with CEO Nicolas Hieronimus, recently commenting, “2021 was a historic year for L’Oréal … Over two years, the Group achieved growth of +11.3 percent like-for-like, spectacularly outperforming a market that had returned almost to 2019 levels.”

The other leading cosmetics brands also did well in 2021. Unilever reported just over $24 billion in beauty and personal care sales, and Estée Lauder had $16.2 billion in sales, an increase of 13 percent over last year.

The “Big 3” of the cosmetics industry have something in common other than strong market performance: Each is committed to transparency and puts it front and center in their business strategy and mission. For example, L’Oréal held a virtual “Transparency Summit” last year, Unilever equates transparency with “integrity,” and Estée Lauder has a dedicated supply chain transparency page on its website.

Transparency and risk management

Despite the opportunity for growth, however, global supply chain challenges can threaten a company’s ability to satisfy growing consumer demand. We all know about the supply chain weaknesses revealed during the pandemic, including overreliance on manufacturing hubs and shipping bottlenecks, not to mention changes in consumer expectations and the way they want to buy and interact with cosmetics.

In a rapidly evolving landscape of tougher regulations, ongoing supply chain uncertainty, increased consumer expectations, and brand risk, transparency has become foundational for success.

Regulatory compliance. Cosmetics regulations vary around the world. For instance, laws in the EU are much broader than in the United States. Generally, however, companies are responsible for making sure their cosmetics are safe, properly labeled, and comply with the regulations that apply to them.

Furthermore, more and more regulatory bodies are calling for modernization via the adoption of digital technologies to ensure products are safe and that companies are able to remain compliant as regulations evolve. Cosmetics supply chain transparency (and traceability) is crucial to compliance. Read our “Global Cosmetics Market” white paper to learn more about regulations in key markets and how technology is driving the industry.

Counterfeits and fakes. And as we’ve written before, counterfeiting is a big problem for the cosmetics industry. Fake products endanger consumers’ health. They can contain toxic substances such bacteria, animal waste, and carcinogenic substances (e.g., lead).

Counterfeits and fakes also damage profits. In “Global Trade in Fakes: A Worrying Threat” (June 2021), the Organisation for Economic Co-operation and Development (OECD) reported that the global value of counterfeits and pirated goods amounted to as much as $464 billion in 2019, or 2.5 percent of world trade.

Brand reputations are also jeopardized by counterfeits. One bad (or very bad) experience can send customers to your competitors and tarnish your image, especially as consumers broadcast their opinions online. Our brand protection series talks more about counterfeits. It’s a real problem that every industry must contend with.

Diversion, theft, and gray markets. The complexity of global supply chains makes it possible for products to end up in markets where they shouldn’t be. Unauthorized or unofficial distribution channels shepherd expired, damaged, or otherwise compromised goods to unauthorized third-party sellers that consumers may think are legitimate. A product bound for Asia winds up in the United Kingdom.

Transparency is not a singular solution for these problems, but it is an indispensable facet of a coordinated, integrated supply chain management strategy to mitigate risk and create real business value.

Mainstreaming sustainability and ESG reporting

As we’ve noted, consumers are demanding more information about the products they purchase; they want to know that ingredients have been ethically sourced and are safe. They want a trust-based relationship with their brands — and if they don’t get it, they’ll happily take their business elsewhere.

This means cosmetics companies must be vigilant and forthcoming about everything in their operations, from their labor standards and how they source raw materials to packaging and other fundamentals of their supply chains. In response, environmental, social, and governance (ESG) reporting has become more prevalent.

ESG reporting measures a company’s social and environmental performance through its supply chain and operations. Cosmetics companies are under pressure, not least from consumers, to reduce their environmental and social impact, set up monitoring systems, use sustainable materials, and publish their social credentials. In this way, ESG reporting is part of cosmetics supply chain transparency.

Or, more accurately, cosmetics supply chain transparency enables effective, accurate ESG reporting.

Leading cosmetics companies are now using ESG reporting, or some form of it, as a strategic tool to monitor their success in sustainability. For example, in 2021, L’Oréal implemented “L’Oréal for the Future,” its sustainability program for 2030. Without mincing words, it prioritizes transparency in product manufacturing, transport, the sourcing and quality of ingredients, sustainability, and more:

“Our commitments towards 2030 mark the beginning of a more radical transformation and embody our view as to what a company’s vision, purpose and responsibilities should be to meet the challenges facing the world.”

Ironically, ESG has enabled some bad players to essentially fake their declarations of transparency and sustainability. It’s called “greenwashing,” when “a company purports to be environmentally conscious for marketing purposes but actually isn’t making any notable sustainability efforts.” Greenwashing is the antithesis of transparency. It’s unethical, and companies that engage in it never intend to meet or quantify their stated transparency, sustainability, and ESG claims.

We’ll be talking more about cosmetics supply chain sustainability tomorrow. Be sure to visit our blog for that.

Final thoughts

Cosmetics supply chain transparency benefits consumers and brand owners alike. For consumers, it means products are safe and legitimate, comply with regulations, and demonstrably rise to the company’s sustainability and ESG goals. For brand owners, transparency offers greater operational efficiencies, mitigates common supply chain risks, and creates opportunities to burnish their reputations, engage with consumers, and tell them with certainty that your products and processes are what you say they are.

Is it difficult to attain transparency? No. Our Traceability System enables companies to follow everything in their supply chains in real time from virtually anywhere in the world. It makes every product a “digital asset” with a certified, provable, and sharable provenance. Its intuitive, scalable solutions can be used individually or as a complete platform to create transparency and end-to-end supply chain traceability and visibility. rfxcel and Antares Vision Group are committed to bringing transparency to all supply chains. We can show you how we do it in about 15 minutes, so contact us to schedule a demo.

And if you’re interested in a transparency case study of sorts, read our global seafood “Transparency Trilogy.” What’s true for seafood is true for cosmetics: Its supply chain reaches into remote areas and involves vulnerable populations and threatened resources.

Understanding FDA DSCSA Guidance for the Pharmaceutical Industry

Posted on August 18, 2022December 19, 2023 by rfxadmin

The Drug Supply Chain Security Act (DSCSA) was passed 10 years ago in November 2013. Congress created the legislation to secure the U.S. pharmaceutical supply chain through unit-level product identification (serialization) and electronic exchange of product information.

Over the years, the FDA has issued updates and revised DSCSA guidance for manufacturers, dispensers, wholesale distributors, and other pharma stakeholders. If your products and/or operations are regulated by the law, it is vital to remain aware of requirements, changes, and deadlines.

Let’s explore the DSCSA guidance and requirements and what the FDA has done in recent years.

What Is the DSCSA?

Created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013, the DSCSA is an initiative to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.

Who Must Comply with the DSCSA?

Manufacturers, wholesale distributors, repackagers, dispensers (i.e., pharmacies, healthcare systems), and third-party logistics providers (3PLs) all have requirements with which they must comply.

Recent DSCSA Guidance Updates

Recently, the most notable action from the FDA was its announcement in August 2023 that it was delaying by one year enforcement of key DSCSA requirements. This “extended stabilization period” moves the enforcement date to November 27, 2024.

This DSCSA guidance primarily affects manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers (PIs) at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products.

Though this gives the industry more time to comply, the Agency has made it clear that the postponement doesn’t amount to a grace period. It said the stabilization period was “not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements.”

You can read the FDA’s official document about the stabilization period here.

Other Noteworthy DSCSA Guidance Updates

July 25, 2022: The FDA published a proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The National Drug Code, or NDC, is the Agency’s “standard for uniquely identifying drugs marketed in the United States.” The codes are usually found on product labeling and might be part of the universal product code (UPC). Read more about the NDC and what the FDA said here.

October 23, 2021: In a policy document, the FDA announced it was delaying enforcement of key requirements to verify saleable returns. It also included guidance for wholesale distributors concerning transaction statements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The timeline below provides an at-a-glance view of DSCSA guidance as the law has been rolled out over the last decade.

DSCSA Guidance in Context, Today

The stabilization period announced in August 2023 did not, in fact, change the original compliance deadline of November 27, 2023; it is up to individual states to decide if they’re going to enforce the requirements before November 2024.

However, the FDA said extending enforcement will give supply chain stakeholders the extra time that may be necessary “to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs.”

What DSCSA Requirements Are in Effect Right Now?

It follows from what we just said that there is DSCSA guidance in effect right now. Some digressions are prohibited per the FD&C Act and can be enforced — with consequences ranging from product seizure to fines to imprisonment. Both federal and state authorities may take action against DSCSA violations.

What Was Enforceable Before Nov. 27, 2023?

Here are a few regulations that can be enforced now. For a full list, see the National Association of Boards of Pharmacy’s (NABP’s) excellent article here. (And also be sure to read about how we were the first DSCSA solution provider to join NABP’s Pulse Interoperable Partner Program. Learn more here!)

All trading partners must be authorized trading partners (ATPs) and can only buy, sell, or trade with other ATPs.
ATPs must be able to identify and manage suspect and illegitimate products.
A product identifier (PI) must be placed on all regulated drug packages and homogenous cases — except for grandfathered products or products with an FDA waiver, exception, or exemption.
ATPs must provide certain information about a drug and who handled it each time it’s sold: transaction information (TI), transaction statement (TS), and transaction history (TH).

What Went into Effect on Nov. 27, 2023?

The November 2023 deadline was when enhanced security requirements went into effect. We’ve written extensively about this for years (in our recently updated DSCSA white paper, for example), but here’s a summary of what companies must do to comply:

Exchange TI and TS securely, electronically, and interoperably. TI must include each package’s unique identifier.
Verify PIs at the package level.
Respond to appropriate tracing requests and trace products at the package level (serialization).
Associate saleable returns with the TI and TS associated with its initial sale.

Final Thoughts About DSCSA Guidance

So what’s the upshot of all this information? It’s simple: Don’t stop preparing.

Use your extra time during the stabilization period to evaluate your systems, communicate and coordinate with your trading partners, and — importantly — ensure you’re working with a solution provider that knows the DSCSA guidance inside and out.

If you have questions about the DSCSA or are concerned that your current provider may not have the tools you need to comply, we encourage you to contact us today to speak with one of our DSCSA experts. We are committed to meeting DSCSA compliance for all our customers in a timely manner.

Everything You Need to Know About Kazakhstan Pharma Serialization

Posted on August 15, 2022August 4, 2023 by rfxadmin

Welcome to Part 2 of our series about Kazakhstan serialization and traceability requirements. Part 1 detailed the country context, including government efforts to achieve pharma independence. October 1, 2022, is the next deadline in the rollout of Kazakhstan pharma serialization, so today we’ll get into the specifics of the regulations, as well as regulations for other key industries. Let’s get started.

Kazakhstan pharma serialization: pilot, goals, operator, timeline, marking requirements

The transformation of Kazakhstan’s pharmaceutical supply chain began almost seven years ago, when the government in September 2015 issued guidelines on labeling, marking, and requirements for accessing and uploading data to a central portal. In November of the same year, the Ministry of Health tapped GS1 Kazakhstan to conduct a pilot for the traceability system, which is called the Special Information System for Marking and Traceability of Goods (IS MPT).

Pilot

The pilot ran from Sept. 9, 2019, to July 31, 2021. It was led by Kazakhstan’s state-run distributor, SK Pharmacy, which labeled 100,000 packages of 30 different drugs and traced them all the way through the supply chain to hospitals and pharmacies. Four domestic manufacturers, 1 importer, 2 distributors, 5 pharmacies, and 8 medical institutions also participated.

Goals

The goals of Kazakhstan pharma serialization — and labeling of other product categories — are essentially the same as regulatory goals in other countries:

- - Communicating product information to consumers
  - Combating counterfeit and falsified products
  - Eliminating gray markets (“Shadow market” seems to be the preferred term in Kazakhstan.)
  - Protecting consumers
  - Protecting legal businesses
  - Identifying entities that violate tax laws

The Kazakh government has also said that digital labeling will help businesses increase productivity, improve logistics, increase market share, ultimately leading to increased revenue.

IS MPT Operator

Kazakhtelecom JSC, the country’s largest telecommunications company, operates the IS MPT. Sometimes referred to as “the Single Operator,” it’s the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT) and Uzbekistan’s CRPT Turon. Its main offices are in Nur-Sultan (formally Astana) and Almaty.

As operator, Kazakhtelecom JSC is responsible for the following:

- - Generating marking codes
  - Providing traceability to the state
  - Interacting with the integrated system of the Eurasian Economic Commission (EEC) and operators in other Eurasian Economic Union (EAEU) states
  - Providing a digital passport of goods for market participants
  - Developing a free mobile application (NAQTY SAUDA) to accept and withdraw marked goods from circulation (primarily for participants who are unable to purchase scanners)
  - Developing a free mobile application (NAQTY ÓNIM) for the public to participate in the system
  - Creating a 24/7 IS MPT contact center

In official government reporting dated Nov. 17, 2020, Kazakhtelecom JSC’s Chair of the Board Kuanyshbek Yessekeyev talked about the benefits of the IS MT. “Among its main advantages,” he said, “one can single out a decrease in the shadow market by 50 percent until 2025, which will lead to additional budget revenues by 2025 in the amount of 58.4 billion tenge [$122.5 million], according to our calculations.”

Yessekeyev also concluded that additional legal business revenues would reach 336.5 billion tenge [$706.5 million] by 2025.

Timeline

Here are the key dates for Kazakhstan pharma serialization:

Planning and pilot

- - September 2015: The government issues guidelines on labeling, marking, and requirements for accessing and uploading data to a central portal.
  - November 2015: The Ministry of Health taps GS1 Kazakhstan to conduct a pilot for IS MT.
  - 2018–2019: GS1 Kazakhstan conducts testing for the pilot.
  - Sept. 9, 2019: The pilot begins.
  - July 31, 2021: The pilot ends and the government issues serialization guidelines.
  - August 8, 2021: The Ministry of Health identifies 93 products — about 1% of all drugs in the country — for the first phase of serialization.

Rollout (note upcoming deadlines in October and early 2023)

- - June 5, 2022: The Ministry of Health delays the first phase of serialization from May 2022 until August 1, 2022.
  - August 2022: Mandatory serialization for the 93 products begins. This list includes drugs produced by four Kazakh manufacturers and 12 foreign manufacturers.
  - October 1, 2022: Mandatory serialization for 20% of drugs scheduled to begin.
  - January 1, 2023: Mandatory serialization for 60% of drugs and mandatory data reporting for 20% of drugs scheduled to begin.
  - April 1, 2023: Mandatory serialization of at least 80% of drugs scheduled to begin.
  - July 1, 2023: Mandatory serialization of 100% of drugs scheduled to begin

Note: At present, Kazakhstan pharma serialization regulations do not require aggregation.

Marking requirements

As in other EAEU and Commonwealth of Independent States (CIS) countries (e.g., Russia and Uzbekistan, respectively), products must be labeled with a DataMatrix code with four data points:

1. 1. A 14-digit product code (i.e., Global Trade Item Number, or GTIN) (GS1 Application Identifier 01)
  2. A 13-character randomized serial number (21)
  3. A four-character verification key (91)
  4. A 44-character verification code (92)

The maximum cost of one code will be 2.68 tenge ($0.0056) without VAT. Every code goes through the same five steps during its “lifetime”:

1. 1. The manufacturer applies a code to every package and sends them to a distributor.
  2. The distributor receives and scans the products, then sends them to the retailer (e.g., a store or supermarket).
  3. The retailer receives the new (legal) batch of goods, scans the codes, and sells the products.
  4. At checkout, the cashier scans each code (either with a scanner or using the NAQTY SAUDA app) and it’s withdrawn from circulation.
  5. Consumers can use the NAQTY ÓNIM app to learn more about the product.

Here are some images of the apps:

Other regulated products/industries

In 2019, Kazakhstan ratified an agreement for labeling of goods within the territory of the EAEU. In doing so, it agreed to the EEC’s decisions concerning labeling of fur products, shoes, perfumes, tires, and other products. Here is the latest information from IS MPT:

- - Tobacco products: Mandatory labeling of cigarettes began Oct. 1, 2020; April 1, 2021, for cigars, cigarillos, and other categories.
  - Fur products: Mandatory labeling began March 1, 2019.
  - Footwear: Production and import of unmarked shoes have been prohibited since Nov. 1, 2021; sale of unmarked shoes has been prohibited since April 1, 2022.
  - Alcohol: Mandatory labeling began April 1, 2021.
  - Light industry (primarily clothing and linens): A pilot ran from Dec. 15, 2020, to Dec. 31, 2021.
  - Dairy products: A pilot began on Oct. 1, 2020, and was extended in November 2021.
  - Soft drinks: A pilot ran from July 1, 2020, to Jan. 31, 2022
  - Jewelry: A pilot began in March 2022 and is scheduled to end on Oct. 31, 2022.

Final thoughts

That’s a lot to think about. We’ve provided the granular details of Kazakhstan pharma serialization requirements, but let’s boil them down to what you have to be ready for in just a few weeks: Mandatory serialization for 20 percent of drugs starts on October 1.

If this affects you, are you ready? The good news is that complying with Kazakhstan pharma serialization requirements doesn’t have to be difficult. The fastest way to ensure you’re ready for the October deadline — and all the 2023 deadlines — is to contact us and walk through our solutions with one of our supply chain experts.

We offer a holistic, fully validated, preconfigured, automated platform for compliance and L1-L5 connectivity. With rfxcel and Antares Vision Group, you’ll be prepared for regulations in the EAEU and everywhere else your supply chain goes.

Kazakhstan Serialization and Traceability Requirements, Part 1

Posted on August 11, 2022August 4, 2023 by rfxadmin

We posted an Uzbekistan pharma serialization update the other day. This got us thinking about Kazakhstan serialization and traceability requirements, as Uzbekistan’s neighbor to the north is working to localize production, digitalize its infrastructure, and incentivize continued growth in key sectors, including pharmaceuticals.

So, welcome to the first of our two-part series about Kazakhstan serialization and traceability requirements. As we did in our series about the Africa supply chain, we’re going to start with context — information about the efforts mentioned above and a snapshot of what’s happening with the pharma industry. Part 2 will get into the specifics of Kazakhstan serialization and traceability requirements in pharma and other sectors.

Kazakhstan serialization and traceability requirements in context

To understand Kazakhstan serialization and traceability requirements, we must first understand what the country is doing to foster economic growth, including modernizing its infrastructure, developing its business enabling environment, and improving the lives of its citizens. Here’s a rundown of what’s been happening.

The Economy of Simple Things

Launched in March 2019, the Economy of Simple Things program is designed to increase domestic production of mostly low-tech, everyday consumer goods and services. The government also hopes to simultaneously boost demand for these goods, decrease reliance on imports, and increase “Made in Kazakhstan” exports.

The program was funded with 1 trillion tenge (almost $2.4 billion in 2019), of which 400 billion tenge (approximately $953 million) was earmarked for manufacturing and services. It was originally slated to end in July 2022 but was extended until the end of 2023.

When Prime Minister Alikhan Smailov announced the continuation, he said the Economy of Simple Things had subsidized more than 1,100 projects valued at almost $2.1 billion, had helped increase production output and payment of taxes by 33 percent and 80 percent, respectively, and had retained and created 67 jobs.

Digital Kazakhstan

Digital Kazakhstan aims to utilize digital technologies to “allow the economy, business, and citizens to enter a fundamentally new development trajectory.” It began in 2018; barring an extension, it will end this year.

The “new development trajectory” means Kazakhstan will work to transition to a digital economy that will improve people’s quality of life. The initiative focuses on five areas, each with publicly stated goals for “What will change/be changed by 2022”:

1. 1. Digitization of the economy: reorganization of the economy using technology to increase productivity and growth; focused on businesses of all sizes. Example of “what will change by 2022”: Labor productivity will increase to the level of “TOP-30 world countries.”

1. 1. Transition to the digital state: transformation of infrastructure to provide services for and anticipate the demands of people and business; calls for “open, transparent, and convenient opportunities” that can be accessed online 24/7. Example of “what will be changed by 2022”: Government services available in electronic format will increase by 80 percent.

1. 1. Implementation of the digital Silk Way: development of a high-speed, secure infrastructure for data transfer, storage, and processing (i.e., internet access and high-quality mobile communications coverage). Example of “what will change by 2022”: ICT development will reach the level of “TOP-30 countries.”

1. 1. Evolution of the human capital assets: transformational changes to enable a creative society and the “transition to the new realities”; calls for a knowledge-based economy and digital literacy through innovations in education. Example of “what will be changed by 2022”: Digital literacy will increase to 83 percent.

1. 1. Innovative ecosystem formation: foster a supportive environment for technological entrepreneurship and industry innovation characterized by stable relations between business, academic institutions, and government. Example of “what will be changed by 2022”: The Astana Hub will become an “international park of IT start-ups.”

Promoting pharma independence

According to the United Nations Comtrade database, a repository of official international trade statistics and relevant analytical tables, Kazakhstan’s pharma imports were valued at $1.56 billion in 2020.

The country’s efforts to attain pharma independence date to at least the mid-2010s. In 2014, for example, the now-discontinued State Program of Accelerated Industrial-Innovative Development (SPAIID) aimed to increase the share of domestically produced medicines to 40-50 percent of the overall market.

How far have they come toward that goal? In October 2020, The Asana Times reported that “the share of domestic manufacturers in the procurement of medicines and medical devices has grown to 30 percent and continues to grow steadily.” It also reported the following:

- - In the first eight months of 2020, production volume increased 34.1 percent, reaching 81.5 billion tenge ($190.28 million).
  - Investments into the industry reached 5.2 percent and 4.1 billion tenge ($9.57 million).

For a little more context, consider these stats from an analysis published in early 2021:

- - In 2018, Kazakh pharma manufacturers produced products valued at 42 billion tenge (about $88 million at current exchange rates).
  - In the first 9 months of 2019, the market for finished pharmaceutical products had grown to 460 billion tenge (about $966 million today), a 22-percent year-on-year increase.

To fuel growth, the government in September 2020 adopted the “Comprehensive Plan for the Development of the Pharmaceutical Industry” through 2025. As reported in the Asana Times, the plan includes the following benchmarks:

- - Thirty new large pharmaceutical operations valued at 77.8 billion tenge ($163.4 million in 2020 dollars)
  - Double medicine production to 230 billion tenge ($537.55 million)
  - Triple exports to 75 billion tenge ($175.10 million)
  - Train more than 2,000 specialists and create permanent jobs for them
  - Increase domestic pharmaceutical production to 50 percent in physical terms

Furthermore, then-Prime Minister Askar Mamin directed the government to scale up support for the domestic pharma industry, especially by stimulating clinical and preclinical trials. He also tasked the Ministries of Industry and Infrastructure Development, Healthcare, and Foreign Affairs to incentivize blue-chip pharma companies to set up shop in Kazakhstan.

One last note for further context: Striving for pharma self-sufficiency isn’t a new idea. For example, earlier this year we wrote about Egypt’s Gypto Pharma City. The Egyptian government envisions this “medicine city” as a regional hub for the international pharmaceutical and vaccine industries, calling it “one of the most important national projects … with the aim of possessing the modern technological and industrial capacity in this vital field.”

Final thoughts

On August 8, the Kazakh Trade and Integration Ministry reported that the country boosted its exports to $34.2 billion between January and May 2022, a 37.2 percent increase over the same period last year.

It seems, then, that the Economy of Simple Things, Digital Kazakhstan, and the Comprehensive Plan for the Development of the Pharmaceutical Industry are reaping dividends. They’re promoting the economic vitality that will help propel the implementation of Kazakhstan serialization and traceability requirements across diverse industries, from pharmaceuticals to footwear.

We’ll talk about those requirements next week in in Part 2. In the meantime, take a look at our solutions for Kazakhstan and the other countries in the Eurasian Economic Union (EAEU). You can also contact us to schedule a short demo of our technologies — rfxcel and Antares Vision Group are committed to ensuring you’re compliant everywhere you do business.

Uzbekistan Pharma Serialization Update: September 1 Deadline & More

Posted on August 10, 2022August 4, 2023 by rfxadmin

We’ve been following the Uzbekistan pharma serialization rollout as part of our ongoing survey of global pharmaceutical regulations and compliance.

As we wrote in mid-February 2022, the country’s State Tax Committee “extend[ed] the timeframe for the phased introduction of mandatory digital markings” of pharmaceutical products. That announcement, however, didn’t stipulate a new deadline.

So, what’s the latest with Uzbekistan pharma serialization? Let’s take a look.

Uzbekistan pharma serialization and Resolution No. 149

On April 2 of this year, Uzbekistan’s Cabinet of Ministers adopted Resolution No. 149, “On the introduction of a system of mandatory digital labeling of medicines and medical devices.” This established the following labeling deadlines for medicinal products and medical devices:

- - September 1, 2022: products produced with secondary (external) packaging (except for orphan drugs)
  - November 1, 2022: products produced with primary (internal) packaging (provided there is no secondary packaging) and medical agricultural products (except for orphan drugs)
  - March 1, 2023: products and medical products to treat orphan diseases as designated by the Ministry of Health
  - March 1, 2023: drugs included in the register of drugs with foreign registrations, the results of which are recognized in Uzbekistan
  - February 1, 2025: medical products on a list approved by tax authorities and the Ministry of Health

Additionally, there seems to be a grace period for the mandatory labeling in two circumstances:

- - Products that were produced domestically within 90 days of these deadlines do not have to be labeled and may be circulated.
  - Products that were imported within 180 days of these deadlines do not have to be labeled and may be circulated.

More about the labeling requirements

The Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).

The regulations currently apply to five product categories other than medicines and medical devices: tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks.

Products in every regulated industry must be labeled with DataMatrix codes that include four data points:

- - A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
  - A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
  - A four-character verification key generated by CRPT Turon
  - A 44-character verification code (i.e., crypto code) generated by CRPT Turon

To learn more about Uzbekistan pharma serialization, how ASL BELGISI works, and labeling requirements, read our “Uzbekistan Traceability Update” from earlier this year. Keep in mind that we wrote this before the first deadline delay and adoption of Resolution No. 149.

Final thoughts

The Uzbekistan pharma serialization deadlines are upon us — about three weeks away. Since its inception, ASL BELGISI has been a hot topic in the industry, especially in key pharma-producing countries.

India, for example, has taken a keen interest in the requirements. One recent article reported that Indian pharma companies are “looking for more clarity over regulations and technical standards … and looking for a transition period to migrate to digital labeling.” The same article noted several other interesting points:

- - India’s pharma exports to Uzbekistan more than doubled in fiscal year 2020-21.
  - India’s export of pharma products to Uzbekistan totaled $137 million in 2021.
  - Uzbekistan’s pharma market is valued at $1.5 billion.
  - There are opportunities for investment and exports in Uzbekistan’s oncology and dermatology sectors.

The good news is that we can help you navigate Uzbekistan pharma serialization requirements no matter where you’re based — India, Asia, the EU, the UK, Latin America, the United States. We have experts in all of these markets, and rfxcel and Antares Vision Group are committed to ensuring you’re compliant everywhere you do business. Contact us today and schedule a short demo of our award-winning Traceability System and our Compliance Management solution.

Why FDA Food Traceability Regulations Are a Business Opportunity

Posted on August 4, 2022August 4, 2023 by rfxadmin

It’s going to be a busy couple of years for the food industry as the Food and Drug Administration (FDA) formalizes key parts of its plan to modernize and further secure the U.S. food supply chain. The next milestone for FDA food traceability regulations is just four months away, so let’s take a look at the requirements — and why food companies should embrace them as an opportunity to improve their businesses.

But first, if you’re intrigued by the idea that opportunities are “hiding” in the FDA food traceability regulations, join us for our “Safety, Regulatory Compliance & Beyond: Leveraging Traceability to Optimize the Food & Beverage Supply Chain” webinar on Wednesday, August 10, at 1 p.m. EST. Our experts will break down the “whys” and “hows” of traceability, discuss the real-world applications and value-adds, and take your questions.

Recap of FDA food traceability regulations & upcoming deadlines

Here’s a quick rundown of what’s on the table and upcoming deadlines.

Food Safety Modernization Act (FSMA)

- - Signed into law on Jan. 4, 2011
  - Aims to ensure the food supply is safe by shifting the focus to preventing contamination rather than responding to it
  - Applies to human food as well as to food for animals, including pets

Proposed Rule (FSMA 204)

- - Establishes additional traceability recordkeeping requirements for people who manufacture, process, pack, or hold foods on the Food Traceability List
  - Food Traceability List contains foods with additional traceability recordkeeping requirements (see table below)
  - Stakeholders to establish and maintain records with key data elements (KDEs) associated with different critical tracking events (CTEs)

Key dates

- - Nov. 7, 2022: FDA to finalize and submit the Food Safety Modernization Act (FSMA) Proposed Rule to the Federal Register
  - January 2023: Proposed Rule goes into effect
  - Jan. 6, 2025: Deadline for full compliance

The FDA has also launched the New Era of Smarter Food Safety and an accompanying New Era of Smarter Food Safety Blueprint, which envision a modern approach to ensuring food safety through digital, tech-enabled traceability. Get more details in our blog here.

FDA food traceability regulations: What to know now and how to seize opportunities

This is really just a preview of our August 10 webinar about leveraging traceability. We’ll touch on a few key points below; sign up for the webinar to take a deep dive.

Just the facts

The FSMA 204 deadlines are set. You’ll have to be fully compliant in about two years, so the time to prepare is now.

The Food Traceability List is a living document. More and more food items are sure to be added over time.

The FDA is committed to modernizing and securing the U.S. food supply chain. Expect the Agency to continue promoting (and regulating) traceability in a digital supply chain. This includes improving recall management.

Where’s the opportunity?

End-to-end traceability makes everything better. With the right solution, you’ll not only be compliant — you’ll make your supply chain faster, leaner, and more cost-effective.

“1-up, 1-down” is useful, but antiquated. Today, 1-up, 1-down traceability is merely a facet of end-to-end traceability (and visibility and transparency) in a digital supply chain. The right solutions transform your supply chain into an ecosystem that optimizes operations and creates opportunity and value beyond the point of sale.

Serialization is the building block of compliance — and added value. Serialization turns every product into a “digital asset” that can be traced in real time from virtually any location, yielding practical benefits to your operations. But these digital assets can accomplish much, much more, including brand protection and consumer engagement.

Traceability enables precise, targeted recall management — which means better outcomes for your brand. We’ve all heard the statistic that the average food recall costs $10 million. With traceability, you can locate specific items quickly, identify where they came from (e.g., grower, warehouse), take clear, decisive action to remove only those items from circulation, and protect consumers and your reputation.

Traceability in a digital supply chain means less clutter — literally. Do you have nightmares about back rooms full of boxes stuffed with paperwork? Traceability turns your nightmare into an operational dream. Get rid of all the paper and gain the power to quickly dial up any document, any time, from any location, including from mobile devices.

Traceability and added value

Traceability is the key to keeping consumers happy and inspired. Consumers are thinking deeply about the things they buy — where they come from and what goes into making them. They also expect to interact with the brands they trust. We wrote way back in October 2020 that supply chain traceability was building a new kind of consumer kingdom; it was true then, it’s true today, and it will be true tomorrow.

The era of digital assets and smart products is here. Products are no longer just products. With serialization and traceability, products are gateways to experiences. They’re beacons to broadcast information. They are conduits for hyper-targeted and hyper-personalized consumer engagement.

Final thoughts

FDA food traceability regulations are center stage in FSMA, the Food Traceability Proposed Rule (FSMA 204), the Food Traceability List, and the New Era of Smarter Food Safety. The deadlines are coming and you should be preparing.

But now you know that savvy companies will see traceability as more than a compliance mandate from the government — they’ll see it as a technology that creates a universe of opportunities for their businesses and brands.

Companies that are thinking only about the mechanics of complying with FDA food traceability regulations will miss these opportunities to be proactive about ensuring food safety and quality, reducing risks, protecting and building their brands, and leveraging every single product to connect with individual consumers in exciting, meaningful ways.

We don’t want you to miss these opportunities. To get started, sign up for our food traceability webinar to see how traceability works and how it delivers value.

Next, contact us to schedule a short demo of our food and beverage solutions, including our award-winning Traceability System and Mobile Traceability App. In about 15 minutes, our supply chain experts will show you how we create end-to-end traceability in a fully interoperable digital supply chain that’s visible anytime, anywhere.

Last, take a look at our other food traceability materials, some FDA links, and our shortened version of the Food Traceability List.

Our FSMA & Food Traceability Resources

Other FDA Resources

Food Traceability List

Antares Vision Group Will Be at GS1 Connect 2022 in San Diego Next Month!

Posted on May 23, 2022August 4, 2023 by rfxadmin

We’re getting excited for GS1 Connect, June 7-9 at the Marriott Marquis San Diego Marina! Not only are we a Premier Sponsor — we’ll be speaking about supply chain traceability and smart hospital systems.

We’ll also be at Booth 115 with our award-winning Traceability System, demonstrating solutions for the food and beverage, pharmaceuticals, and cosmetics industries.

So take 20 seconds (really) to sign up to meet us. We have a limited number of discount codes for 10 percent off your registration fee. And while you’re at Booth 115, take our short survey and you could win a $500 DoorDash gift card.

More about GS1 Connect and our speakers

The theme of this year’s conference is “Adapt.” The focus is on how businesses have used GS1 Standards to overcome challenges to thrive in uncertain times. There will be 40+ live sessions (including ours!), 50+ exhibitors (including us!), trading partner roundtables, and other events centered on user stories and leadership insights for supply chain optimization.

As GS1 says, the event is a place to “network with the greatest supply chain minds and learn how to leverage GS1 Standards to optimize your business.” Indeed.

In “Supply Chain Traceability: Can Your Business Survive Without It?” Herb Wong, our vice president of product and strategy, will discuss why traceability is foundational to business success in a rapidly evolving landscape of digitalization, ever-changing consumer expectations and power dynamics, tougher regulations, and supply chain uncertainty. He’ll be speaking on Thursday, June 9, at 1:45 p.m.

In on-demand session 509, “Smarter and Safer Hospitals: When Innovative Technologies Meet Patient Safety,” our Digital Healthcare Department Director Adriano Fusco and Dr. Alberto Sanna, director of the Research Center for Advanced Technologies for Health and Well-Being of the IRCCS San Raffaele Hospital in Milan, Italy, will discuss how traceability and GS1 Standards enable end-to-end visibility of medications from arrival at the hospital to dispensation and optimized resources to focus on patient safety.

Final thoughts

We’ve always valued GS1 Standards, and we’ve always ensured our customers can adhere to them and take full advantage of them to maximize efficiency and create value across their operations everywhere they do business.

And who took the time to note the 50th anniversary of the venerable Global Trade Item Number (GTIN)? We did, with a blog post devoted to GS1 barcodes.

As we said in that article, “Where would we be without standards?” We’d love to see you at GS1 Connect and talk about those standards and how they fuel traceability. We hope you’ll take those few seconds to sign up to meet us at Booth 115, get 10 percent off your registration, and enter to win a nice prize when you take our survey.

In the meantime, drop us a line if you have any questions or want to know more about our traceability solutions for pharma, food and beverage, cosmetics, and other industries. We never pass on an opportunity to talk about what makes us your best partner for end-to-end supply chain solutions, from L1 all the way to L5!

See you in San Diego June 7-9!

Brazil ANVISA Deadline Is Just Two Weeks Away. Here’s What You Need to Know.

Posted on April 14, 2022August 4, 2023 by rfxadmin

The Brazil ANVISA deadline is just two weeks away. On April 28, 2022, pharmaceutical companies must comply with the serialization, reporting, and traceability requirements set out in the National Medicine Control System (SNCM), which the Brazilian Health Regulatory Agency — ANVISA — signed into law a little more than five years ago.

If you follow our blog (and we know you do), you know we’ve covered ANVISA and the SNCM since Day 1. You could also probably guess that we weren’t going to miss this opportunity to share more update about what to expect as the Brazil ANVISA deadline countdown enters its final days. Let’s take one last look.

Brazil ANVISA deadline and the SNCM: A recap

The Brazil ANVISA deadline has been on the industry’s radar since the SNCM was passed on December 28, 2016 (as Law No. 13.410/2016). It regulations will help Brazil protect its almost 213 million citizens against common problems in the drug supply chain, such as counterfeits and theft.

The SNCM requires every pharma supply chain actor to capture, store, and exchange data electronically. All products must have a GS1 2D Data Matrix barcode with five data points:

Global Trade Item Number (GTIN)
A 13-digit ANVISA Medicine Registry Number
A unique 13-digit serial number
An expiration date (in the MM/YY format for human-readable form)
A lot/batch number (up to 20 alphanumeric characters)

The ANVISA Medicine Registry Number, serial number, expiration date, and lot/batch number make up the Unique Medicine Identifier (Identificador Único de Medicamentos), or IUM, which must be printed on every product. Compliant labeling might look something like this:

Overall, there are three key requirements for the April 28 Brazil ANVISA deadline:

All prescription medicines must be serialized.
All manufacturers and importers must have a “serialization plan” in the SNCM portal.
All supply chain stakeholders must submit product event reports to the SNCM.

For serialization plans in the SNCM portal, manufacturers and importers must provide information about their relevant product lines and medicines. Manufacturers were also required to submit a serialization plan that includes all steps and actions they would take to become compliant by the deadline.

Final thoughts

As we said above, this is our last look at the Brazil ANVISA deadline and SNCM requirements before April 28. However, it is most definitely not the last you’ll hear from us about Brazil’s pharma market and how it’s being regulated. We will continue monitoring the situation, posting updates, and answering your questions — always.

Undoubtedly, we’ve established ourselves as a leader in solutions for Brazil ANVISA and the SNCM. We’ve fine-tuned our software to help manufacturers and other pharma stakeholders achieve SNCM compliance, and we’ve prioritized assisting companies to be 100 percent compliant throughout the long rollout of the regulations. We’ve also built a dedicated São Paulo-based team that’s been extraordinarily active and involved every step of the way.

So, if you hear this or that provider saying they’re the only company offering a comprehensive solution, platform, or framework for SNCM compliance — or any other compliance requirements — be skeptical. Then contact us to get the straight talk about what you need to do and how our compliance and supply chain traceability solutions will get you where you need to be quickly and efficiently, no matter where you do business.

Keep an eye on the April 28 Brazil ANVISA deadline and drop us a line if you have questions!

DSCSA EPCIS Update: 3 Questions for rfxcel SVP of Product and Strategy Herb Wong

Posted on March 24, 2022August 4, 2023 by rfxadmin

Herb Wong’s a busy guy. As senior vice president of product and strategy at rfxcel, he’s always on the go, advising and conferring with customers, talking and brainstorming with industry leaders, dashing off to speak at conferences, and thinking of new ways to improve … everything. So we were happy that he found time to talk with us about what’s happening with DSCSA EPCIS.

Our chat comes as Herb is fresh off an appearance at the Healthcare Distribution Alliance (HDA) Distribution Management Conference in Austin, Texas, where he participated in the “EPCIS Standards and Implementation Process” panel discussion. HDA also recently published a DSCSA EPCIS Implementation Benchmarking Survey about the progress of adoption and trading partner plans for sending data.

Here’s the scoop:

Herb, what has the EPCIS Center of Excellence learned about industry readiness for the DSCSA EPCIS requirements?

Well, the EPCIS COE, which we introduced at the HDA Quarterly Update in September last year, has discovered a number of things through our studies and meetings. Here are takeaways in the key areas of education, consistency, and standards.

As we get closer to the November 2023 deadline, new participants are less knowledgeable about EPCIS and DSCSA. Their integrations take more time and they have more questions and need more education. This was a recurring theme we started hearing during our EPCIS COE interviews. Because of this, the HDA and GS1 are looking to see how they can offer/repackage training to get the industry up to speed.

In terms of consistency, we are looking into developing a common, consistent process for all solution providers to begin an EPCIS exchange. This can improve the efficiency across all supply chain partners.

And for standards, we have been discussing a process or tool to have all participants verify that their EPCIS data is formatted correctly before they begin exchanging it with others. GS1 developed an offering for this and everyone agrees that it’s a good idea; but determining who pays for this testing has been challenging.

How has the industry reacted to the EPCIS COE’s efforts?

Overall, everyone has been receptive. But this is a huge undertaking. It reminds me of the question, “How do you eat an elephant?” Answer: “One spoonful at a time.” Accelerating EPCIS data exchange is like that. It’s so big that people don’t know exactly where to start.

The answer is to just start somewhere and then learn and improve. The hardest part is getting started. Once we decide on a few areas where we can make an impact, momentum will keep us moving forward. We are in the process of agreeing on what we can do, so stay tuned!

What are your thoughts about industry readiness?

A number of supply chain partners asked me this question at the HDA Distribution Management Conference in Austin earlier this month. The industry is becoming more focused on the deadline. Everyone is realizing that the time for open-ended discussion is coming to a close and decisions must be made. We have 19 months to be ready for DSCSA 2023 and a lot of different efforts must be aligned.

Final thoughts

Herb Wong, everyone!

We hope Herb’s answers were helpful and shed light on the industry’s efforts to be ready for the DSCSA EPCIS requirements. As he said, it’s an elephant-sized undertaking with a lot of moving parts that need coordination and consensus. The EPCIS COE is “the spoon” that’s helping the pharmaceutical industry digest the requirements, address the challenges, and get everyone compliant by November 27, 2023.

If you still have questions, your first step should be to contact us. One of our supply chain experts can explain the requirements and how our solutions will get your house in order. If you like, we can probably arrange a meeting with Herb. So reach out today and let’s talk.

We also encourage you to browse our DSCSA Compliance Library. It’s a clearinghouse of information with links to our blog posts, white papers, webinars — everything — about the law, including EPCIS requirements.

Last, we want to let you know that in June Herb will head to San Diego to speak at the GS1 Connect 2022 conference. On Thursday, June 9, he’ll present “Supply Chain Traceability: Can Your Business Survive Without It?” Herb will discuss why traceability is foundational to business success and how companies in any industry can leverage traceability in a digital supply chain to ensure they comply with regulations and much more. Check back for updates as we get closer to June!

African Pharmaceutical Regulations: The African Medicines Agency and the Push for Harmonization

Posted on March 3, 2022August 4, 2023 by rfxadmin

Welcome to the last installment of our Africa supply chain series. Part 1 talked about geography, demographics, and the economy, and Part 2 was about challenges and opportunities. Today, we’re tackling the complex landscape of African pharmaceutical regulations.

Specifically, we’re looking at the African Medicines Agency (AMA), envisioned as a single regulatory body that would cover all 54 countries on the continent. It’s a big topic, but we’ll break it down into easy-to-understand terms. Let’s get started.

African pharmaceutical regulations: defining the key players and terminology

To understand African pharmaceutical regulations, you have to know the key players and be familiar with some core vocabulary. Today, we’re talking in broad terms to establish some baseline knowledge; if you want to know more about any of the entries below, just click on the linked text.

African Medicines Agency (AMA): According to its business plan, the AMA’s vision is “a healthy African population with access to quality, safe, and efficacious medical products and technologies.” It was established in January 2015 and officially began in November 2021 after 15 countries signed and ratified the AMA Treaty and deposited their instruments of ratification with the African Union Commission (see below). The AMA does not yet have a website; visit the African Union website for more information.

African Medicines Regulatory Harmonization (AMRH): Formalized in 2009, the AMRH is an initiative to “provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa.” It is part of the African Union Development Agency (see below) and the Pharmaceutical Manufacturing Plan for Africa (PMPA).

African Union (AU): The AU was launched in 2002, succeeding the Organization of African Unity, which was active from 1963 to 1999. It comprises five regions and has 55 members: Central Africa (9 states), Eastern Africa (14 states), Northern Africa (7 states), Southern Africa (10 states), and Western Africa (15 states).

African Union Commission (AUC): The AUC is the AU’s secretariat and runs the day-to-day activities of the Union. It is based in Addis Ababa, Ethiopia.

African Union Development Agency (AUDA-NEPAD): AUDA-NEPAD’s mandate is to “coordinate and execute regional and continental projects to promote regional integration towards the accelerated realization of Agenda 2063” and “strengthen capacity of AU member states and regional bodies.” (See Part 1 of our series for more about Agenda 2063 and read the AUDA-NEPAD 2021 Annual Report here.)

National Medicines Regulatory Authorities (NMRAs): Each country’s NMRA is responsible for regulatory functions such as marketing authorization, pharmacovigilance, market surveillance quality control, clinical trials oversight, licensing establishments, and laboratory testing.

Regional Economic Communities (RECs): RECs are regional groupings of African countries formed to facilitate regional economic integration and the wider African Economic Community. The AU recognizes eight RECs:

1. Arab Maghreb Union (UMA)
2. Common Market for Eastern and Southern Africa (COMESA)
3. Community of Sahel-Saharan States (CEN-SAD)
4. East African Community (EAC)
5. Economic Community of Central African States (ECCAS)
6. Economic Community of West African States (ECOWAS)
7. Intergovernmental Authority on Development (IGAD)
8. Southern African Development Community (SADC)

Regional Centers of Regulatory Excellence (RCORE): AUDA-NEPAD, through AMRH, designated 11 RCOREs to work in eight regulatory functions to build regulatory capacity at NMRAs:

African pharmaceutical regulations: current context

With the AMA going into force barely five months ago, and considering the vastness of the African continent and the diversity of its countries, it should be no surprise that the current context for African pharmaceutical regulations is … one of flux.

Authorities (e.g., the AU and AUDA-NEPAD), through the NMRAs and RCORES, as well as through coordination with the RECs, are working through the many challenges of harmonizing regulations. There are a lot of moving parts that need to coalesce under the AMA umbrella. For example:

Different legal and regulatory frameworks. Many countries and RECs have developed or are developing their own regulatory legislation. But right now, it appears they are not obligated to coordinate, standardize, or harmonize their laws. Therefore, regulations can vary from country to country in a REC, and any country’s laws might also diverge from their REC’s requirements. Regulations also vary from REC to REC, such as the Southern African Development Community (SADC), the East African Community (EAC), and the Economic Community of West African States (ECOWAS).

Furthermore, legal and regulatory frameworks can be unclear and incomplete, and authorities may not make public announcements about their intentions, timelines, and progress. Manufacturers and other supply chain stakeholders may have to submit paperwork to more than one NMRA, which duplicates efforts and wastes resources.

Need for capacity-building. A March 2021 article in the Journal of Pharmaceutical Policy and Practice noted that all but one country had an NMRA or “an administrative unit conducting some or all expected NMRA functions,” but only 7 percent had “moderately developed capacity” and more than 90 percent had “minimal to no capacity.” Complicating matters, some NMRAs operate as independent organizations and some operate within their country’s Ministry of Health.

Reliance on imports and the problem of counterfeits. The United Nations Economic Commission for Africa (UNECA) estimates that Africa imports about 94 percent of its pharmaceutical and medicinal needs at an annual cost of $16 billion. This is a regulatory and logistical challenge. It also means there are plenty of opportunities for illegal activity. We noted in Part 2 that 42 percent of all fake medicines reported to the WHO from 2013 to 2017 came from Africa. The WHO also estimates that one of every 10 medical products in low- and middle-income countries is substandard or fake, while another report says up to 70 percent of pharmaceuticals could be fake in developing regions.

The African Medicines Agency

These disparities, capacity needs, and logistical challenges were among the reasons why the AU wanted to establish a continental regulatory system. And like other regulatory systems, the AMA is designed to protect people, to ensure that all Africans have access to safe, efficacious, and affordable products that meet international standards.

The AMA is based on the AU Model Law on Medical Products Regulation. In broad terms, its goal is harmonization by achieving the following:

- - Registration and marketing of health technologies
  - Granting manufacturing and distribution licenses
  - Conducting quality and safety inspection of health technologies and manufacturing facilities
  - Authorizing clinical trials through an established National Ethics Committee or Institutional Review Board
  - Overseeing appeals procedures through an established Administrative Appeals Committee

International reaction to the AMA has been mostly positive. The International Federation of Pharmaceutical Manufacturers & Associations, for example, said that the “AMA has the unique opportunity to become one of the most efficient and modern regulatory systems in the world.”

And just last month before a two-day EU-AU summit, the EU (including the European Commission, the European Medicines Agency, and member states Belgium, France, and Germany) and the Bill & Melinda Gates Foundation announced they would mobilize more than 100 million euros over the next five years to support the AMA and other pharma regulatory initiatives at regional and national levels.

As of March 3, 2022, 30 African countries had backed the AMA: 19 had signed and ratified the AMA Treaty and deposited their instruments of ratification with the African Union Commission; two had signed and ratified but not deposited; and nine had signed but not ratified. Thirteen countries have said they’d want to be home to the AMA headquarters.

Still, 25 countries have not signed the AMA Treaty, including South Africa, Nigeria, Kenya, and Ethiopia, four of the most important economies on the continent.

Final thoughts

African pharmaceutical regulations and the AMA are evolving. And like all regulations, there will be stops and starts.

The important takeaway is this: The pharma industry must be prepared for the continent-wide AMA regulations and the AU’s vision of a single authority working with a harmonized set of standards. Though there are holdouts, Egypt, Africa’s third most populous country and an important economic power, has ratified and deposited the treaty. This is a significant event in the efforts to get those countries on board with the AMA.

Preparation is the key to compliance and keeping your supply chain running. And we’re experts in making sure you’re prepared for regulations — and every other aspect of supply chain management and optimization — everywhere you do business. Pharmaceutical companies rely on our solutions to comply with strict regulations and to get the most out of their supply chains, from harvesting rich, actionable data in real time to leveraging serialization technology for brand protection and consumer engagement.

Contact us today to speak with one of our experts. In just a few minutes, they can show how our Traceability System will optimize your supply chain today and, importantly, ensure you’re prepared for what’s coming tomorrow.

And if you’re like us and just can’t get enough of regulations and compliance, download our updated “Pharmaceutical Compliance: A Global Overview” white paper. We’ve added more than 25 countries, including REC member states, expanded our “rfxcel Compliance Resources” section, and a lot more. Get it today!

Last but not least, take a look at our other news from the Africa and Middle East region: