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Why FDA Food Traceability Regulations Are a Business Opportunity

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

FDA Food Traceability List

Antares Vision Group’s Acquisitions: Advancing Food & Beverage Quality Control with rfxcel

Travagliato (Brescia), August 2, 2022. Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems that guarantee the transparency of products and supply chains through integrated data management, today announced that it had acquired 100 percent of Packital SRL and of Ingg. Vescovini SRL through its subsidiary company FT System.

Packital, based in Fidenza (PR), Italy, has since 1989 developed, designed, produced, and distributed inspection and quality control systems such as checkweighers, metal detectors, X-rays, and weight sorters. It specializes in wet and difficult environments, including those in which corrosive products are present. The company is certified as an Inspection Body for checkweighers.

Founded in 1984, Parma, Italy-based Ingg. Vescovini SRL develops, designs, and produces analogue and digital electronic boards, fundamental components for checkweighers, weight dosing systems, inspection systems in the beverage sector, electromedical machines, and control systems in the agricultural and industrial sectors.

“We are continuing along the path toward the technological growth and expansion of our portfolio,” said Emidio Zorzella, chairman and joint-CEO of Antares Vision Group, “keeping with our mission to guarantee the quality, safety, efficiency, and sustainability of products and supply chains.”  

Fabio Forestelli, CEO of FT System and a member of the Antares Vision Group Board, added, “With Packital and Ingg. Vescovini, we will further strengthen our presence in the food and beverage sector by extending our portfolio of inspection and quality control solutions that are complementary to current ones. In this way, we can strengthen our facility with qualified personnel who specialize in inspection technologies, increasing our technical and production capacity as well as our market presence.”

Giacomo Vacca, CEO of Packital, said, “After 30 years of experience, passion, and expertise in food and beverage inspection solutions, we have chosen Antares Vision Group to continue to increase the market value we have already created, thanks to shared values and objectives.”

“The 60 years of experience in our industry are a fundamental value, which looks to the past, but enables us to see the future,” said Ingg. Vescovini CEO Paolo Vescovini. “We are grateful to all of our staff for the contribution they have made thus far and we are sure that joining Antares Vision Group is an important opportunity for us to continue to innovate.”

Strategic rationale

The acquisitions of Packital and Vescovini represent an important strategic opportunity for Antares Vision Group, insofar as they maintain and strengthen its positioning in the food and beverage sector, which started in 2021 with the acquisitions of Pentec and Tecnel, through the subsidiary company FT System. More specifically, they will allow The Group to:

Consolidate its market positioning thanks to:

  • A portfolio of quality control and inspection systems that are unique and unparalleled in the market, in terms of variety and extent of the range
  • The completion of the current range with quality control solutions in difficult environments (dusty, wet, corrosive)
  • Expand the range of services provided, also for the periodic certification of weighing instruments

Increase its market share in the Food & Beverage sector, thanks to:

  • An active customer base (approximately 400), the majority of which are new to The Group
  • Technological coverage in terms of fundamental components such as electronic boards

Strengthen its technological know-how

  • In inspection and quality control, thanks to a highly qualified team for software design and programming, with expertise accrued over the years
  • In electronic boards, by maintaining the know-how (schematics and source files) that Vescovini has developed for FT System over the years; increasing current developments, with a design, production, and assistance team in the food sector; offering customized solutions, able to promote customer loyalty and consolidate customer relations; maintaining technological leadership able to lead innovation and development in this specific field

Increase production capacity

  • Thanks to quality controls and inspections that will increase the existing base for some types
  • Thanks to proprietary electronic boards and relative management software, to meet both market demand and the needs of the Group, guaranteeing a useful reserve to handle supply chain shortages

Cross-technology opportunities as a Group

  • Thanks to the proprietary electronic boards and relative management software, able to support the technological needs of the group’s different product units, by developing innovative applications in current and future projects

Cross-industry opportunities as a Group

  • Thanks to quality and inspection controls, which can be adopted in current and potential business areas

Paolo Vescovini, the current Chairman of Packital and Vescovini, will be bound by a three-year Management agreement to guarantee a smooth handover. Their geographical proximity, know-how and reciprocal respect will contribute to facilitating the integration.

About Antares Vision Group

Antares Vision Group is an outstanding technology partner in digitalization and innovation for enterprises and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection. Antares Vision Group is a technological enabler of supply chain transparency and sustainable transition to protect business competitiveness and the uniqueness of each country. It provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials and production to distribution to the consumer), with integrated data, production and supply chain management, also achieved through the application of artificial intelligence and the use of blockchains.

Antares Vision Group is active in the life sciences sector (pharmaceutical, biomedical devices, and hospitals), in the beverage, food, and cosmetics industries, and has potential in other sectors. The world leader in track and trace systems for pharmaceutical products, it provides major global manufacturers (more than 50 percent of the Top 20 multinationals) and numerous government authorities with solutions to monitor their supply chains and validate product authenticity.

Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from May 14, 2021, in the STAR segment of the Mercato Telematico Azionario (MTA) (electronic equity market), Antares Vision Group recorded a turnover of Euro 162 million in 2020, operates in 60 countries, employs approximately 1,000 people, and has a consolidated network of more than 40 international partners. For more information, visit www.antaresvision.com and www.antaresvisiongroup.com.

Antares Vision Group Selected to Speak on Supply Chain Traceability and Smart Hospital Systems at GS1 Connect 2022

AV Group members will present “Supply Chain Traceability: Can Your Business Survive Without It” and “Smarter and Safer Hospitals: When Innovative Technologies Meet Patient Safety”

Travagliato (Brescia), June 1, 2022 Antares Vision Group (AV Group), a technological partner of excellence in digitalization and integrated data management, the global leader in track and trace hardware and software solutions, and one of the main players in inspection systems for quality control and integrated data management, has been chosen to provide thought leadership presentations at the GS1 Connect Conference, June7-9 in San Diego.

In “Supply Chain Traceability: Can Your Business Survive Without It?” Herb Wong, vice president of strategy and innovation at rfxcel, which is part of AV Group, 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. The session will be held Thursday, June 9, at 1:45 p.m.

In on-demand session 509, “Smarter and Safer Hospitals: When Innovative Technologies Meet Patient Safety,” Antares Vision 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, will discuss how traceability and GS1 standards enabled end-to-end visibility of medications – from their arrival at the hospital to dispensing – through the use of optimized resources that focus on patient safety.

AV Group Chairman and Co-CEO Emidio Zorzella said he was excited that GS1 Connect attendees would have the opportunity to hear Mr. Wong, Mr. Fusco, and Dr. Sanna talk about the Group’s technology. “The ultimate goals of traceability and GS1 standards are to protect people and optimize business processes,” he said. “These are also AV Group’s goals. I think people will have a strong reaction when they see how our technology is improving people’s lives, making businesses more efficient and effective and, we hope, making the world a better place.”

GS1 Connect is an annual event hosted by GS1 US. It brings together trading partners to network and learn about the value of using standards-based business processes and best practices for optimum efficiencies in managing the supply and demand sides of their value chains. The theme of this year’s conference is “Adapt,” focusing on how businesses have used GS1 Standards to overcome challenges to thrive in uncertain times. It will feature more than 40 live sessions, more than 50 exhibitors, trading partner roundtables, and other events centered on user stories and leadership insights for supply chain optimization.

For more information, contact AV Group Public Relations Specialist Davide Antonioli at davide.antonioli@antaresvision.com or +39 339-812-4446.

 

ABOUT ANTARES VISION GROUP

Antares Vision Group is an outstanding technology partner in digitalization and innovation for enterprises and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection.

AV Group provides a unique and comprehensive ecosystem of technologies — including software and hardware — to guarantee product quality (inspection systems and equipment) and end-to-end traceability (from raw materials to production, from distribution to the consumer), through integrated data management, applying artificial intelligence and blockchain too.

AV Group is active in the life sciences (pharmaceuticals, biomedical devices, and hospitals), beverage, food, and cosmetics industries, and is expanding into other sectors. The world leader in track and trace systems for pharmaceutical products, it provides major global manufacturers, including more than 50 percent of the Top 20 multinationals, and numerous government authorities with solutions to monitor their supply chains and validate product authenticity.

Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from May 2021 in the STAR segment of the Mercato Telematico Azionario (MTA) (electronic equity market), AV Group operates in 60 countries, employs approximately 1,000 people, and has a consolidated network of more than 40 international partners. antaresvisiongroup.com

rfxcel, part of AV Group, has deep expertise in providing leading-edge software solutions to help companies build and manage digital supply chains, lower costs, protect products and brand reputations, and engage consumers. rfxcel.com

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

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.

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:

  1. Global Trade Item Number (GTIN)
  2. A 13-digit ANVISA Medicine Registry Number
  3. A unique 13-digit serial number
  4. An expiration date (in the MM/YY format for human-readable form)
  5. 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:

Brazil ANVISA IUM

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

  1. All prescription medicines must be serialized.
  2. All manufacturers and importers must have a “serialization plan” in the SNCM portal.
  3. 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

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

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:

Understanding the Supply Chain in Africa: Essential Insights for the Track and Trace Industry

Welcome to Part 2 of our look at the supply chain in Africa. In Part 1, we did “Africa by the numbers,” getting into the details of the continent’s geography, demographics, economy, and goals of “Agenda 2063.” Today, we’re talking about three challenges and three opportunities. There’s a lot to cover, so let’s get started.

Three challenges for the supply chain in Africa

As we said in Part 1, Africa is big: about 11.7 million square miles (30.3 million square km). The continent has eight primary physical regions — the Sahara, the Sahel, the Ethiopian Highlands, the savanna, the Swahili Coast, the rain forest, the African Great Lakes, and Southern Africa — and traversing these diverse landscapes is not always easy.

Which brings us to the first challenge for the supply chain in Africa: physical and electronic infrastructure. Stated simply, Africa has a long way to go with infrastructure. McKinsey & Company’s “Solving Africa’s infrastructure paradox” (March 2020) provides a good overview of this challenge, the paradox being that there’s a high demand for projects and sufficient capital, but not much action. Specifically,

“… infrastructure investment in Africa has been increasing steadily over the past 15 years, and … international investors have both the appetite and the funds to spend much more across the continent. The challenge, however, is that Africa’s track record in moving projects to financial close is poor: 80 percent of infrastructure projects fail at the feasibility and business-plan stage.”

One eye-opening statistic from the McKinsey article: More than two-thirds of the world’s population that does not have access to electricity lives in sub-Saharan Africa. That’s 600 million people. The challenge is self-evident. Agenda 2063 has ambitious infrastructure components (e.g., rail, air, water) and could very well smash this paradox. But it will take time.

Here are two other key challenges for the supply chain in Africa:

The informal economy. The Center for Global Development reports that Africa’s informal sector is the largest in the world, citing International Labor Organization statistics that it accounts for almost 90 percent of the economy in sub-Saharan Africa and about two-thirds in North Africa. Research from 2019 showed that the informal sector provided 90 percent of all new jobs and 70 percent of all employment across sub-Saharan Africa.

In Africa’s urban areas — the fastest-growing in the world — World Bank data shows that almost 81 percent of jobs are in the informal sector, while the International Labor Organization reported that almost 96 percent of youth ages 15-24 and a little more than 93 percent of women work in the informal economy.

This means that a significant part of the supply chain in Africa is informal, operating through non-official channels and without government oversight, regulation, or taxation. This makes it difficult for businesses to operate in Africa and enables an environment in which other supply chain problems can arise.

Counterfeits. Illegal copying and counterfeiting is widespread in Africa, as it is in other parts of the world with unregulated informal economies and insufficient supply chain protections. Bad actors are only too happy to exploit these conditions.

For example, 42 percent of all fake medicines reported to the World Health Organization from 2013 to 2017 came from Africa. (WHO estimates one of every 10 medical products in low- and middle-income countries is substandard or fake.) Reading between the lines, the proliferation of counterfeit medicines in Africa’s supply chain might be even greater, as weak regulations and lax enforcement often results in under reporting.

To illustrate the problem, last year an Interpol-supported operation in Southern Africa targeting “trafficking of illicit health products and other goods” nabbed 179 suspects and seized products worth approximately $3.5 million. Examples of similar events include the following:

    • 2015-2018: Almost 20 tons of fake medicines seized in Mali
    • 2017: More than 420 tons of illegal pharmaceutical products seized in seven West African countries
    • 2018: 19 tons of counterfeit medicines seized in Ivory Coast, Guinea-Bissau, Liberia, and Sierra Leone
    • 2019: 12 tons of counterfeit pharmaceuticals intercepted in Ghana

But official channels are working to address the problem, including these initiatives:

    • The United Nations Office on Drugs and Crime announced a “holistic strategy” to combat crime and fake drugs in West and Central Africa.
    • The African Union announced that the African Continental Free Trade Area (AfCFTA) Secretariat had signed a letter of intent to work with other partners to combat counterfeit trade.
    • The Lomé Initiative is a binding agreement among the Republic of the Congo, Niger, Senegal, Togo, Uganda, Ghana, and the Gambia to criminalize trafficking falsified medicines.
    • The legal profession is also aware of the problem.

Three opportunities for the supply chain in Africa

The rise of manufacturing. African manufacturing made headlines last month when Afrigen Biologics and Vaccines in Cape Town, South Africa, announced it had successfully copied Moderna’s COVID-19 vaccine with no input from the U.S.-based company. At about the same time, the director of the Africa Centers for Disease Control and Prevention said 10 countries were making vaccines right now or planning to do so, with South Africa, Senegal, Rwanda, Algeria, and Morocco taking leading roles.

Led by organizations such as the African Partnership for Vaccine Manufacturing and the African Vaccine Manufacturing Initiative, a coordinated push is underway to manufacture vaccines in Africa “from scratch” (i.e., not merely “filling and finishing” imported products) and make the continent “vaccine independent.”

And this is emblematic of an African manufacturing renaissance of sorts. In the second quarter of 2021, for example, United Nations’ growth estimates indicated a 17.8 percent expansion of manufacturing output. (Output had dropped by 17.1 percent during the same period in 2020, primarily attributable to the pandemic.) Also in the second quarter of 2021, manufacturing output increased “in many African countries,” including South Africa (39.3 percent), Rwanda (30.2 percent), Senegal (22.6 percent), and Nigeria (4.6 percent).

Other examples are abundant: Carmaker Nissan is opening new facilities, and analysts see Africa emerging as an auto industry hub, including for electric vehicles. Overall, research shows that manufacturing on the continent is growing, or strongly rebounding from the pandemic, especially in key economies in sub-Saharan Africa.

A healthy manufacturing sector means a supply chain with opportunities to modernize alongside production facilities, to adopt international standards (e.g., GS1) and best practices, and to build the infrastructure to secure products from the time they leave the manufacturing floor to the time they reach consumers.

A large — and young — labor force. As we noted in Part 1 of our series, approximately 1.4 billion people live in Africa (about 17 percent of the world population) and the median age is 19.7, making it the youngest continent on the planet. According to the World Bank, half of the population in Sub-Saharan Africa will be under 25 by 2050.

This could poise African countries for an employment/ongoing manufacturing boom similar to what’s happened in Vietnam, Malaysia, Singapore, Mexico, and India. With more jobs in more sectors, including technology, and more products originating on the continent, the supply chain will need to grow and adapt. This will create opportunities for modernization and synchronization with global standards and best practices.

A consumer-centric economy. Africa is an enormous market for domestically produced and imported goods and services. As AfCFTA matures and projects under Agenda 2063 and other initiatives are completed, hundreds of millions of consumers should have more and easier access to these goods and services. They should also be willing to spend more money: As of 2021, the final household consumption expenditure in Africa was a little more than $1.9 trillion; McKinsey says this could reach 2.5 trillion by 2025.

This will have a huge impact on the supply chain in Africa — for manufacturing, logistics, distribution, warehousing, and “the last mile.” The more vigorous Africa’s economy becomes, the more businesses should anticipate development of new industries, dissipation of the informal sector, increased demand for better products, and a growing “consumer class” that will come to expect the supply chain to work everywhere on the continent.

Final thoughts

The supply chain in Africa is a work in progress. Some countries, particularly those in Sub-Saharan Africa, are farther along than others. The reasons for this are diverse, ranging from stronger institutions and more stable infrastructure to fortunate geography that facilitates better access to the flow of global trade.

It’s the wise organization that follows the progress and continuously prepares to do business in Africa. This means being able to work with the supply chain, complying with regulations as they’re rolled out and refined, optimizing your systems — and finding the right solution provider.

Contact us today to speak with one of our digital supply chain experts. In just a few minutes, they’ll demonstrate how our Traceability System will ensure your business can integrate with the supply chain in Africa. After doing that, move on to the last installment of our Africa supply chain series, which highlights the pharmaceutical regulatory environment. In the meantime, think about your supply chain and consider the words of Dr. Akinwumi Ayodeji Adesina, president of the African Development Bank Group:

The future belongs inexorably to the continent of Africa. By 2050, it will have the same population as China and India do now. There will be burgeoning consumer demand from a growing middle class, a population of nearly 2 billion people, of which around 800 million young people will be looking for meaningful and sustainable employment.

If we can harness this potential by aligning supply with demand, markets with customers, and skills with jobs, and keep most of these elements and links largely within Africa, then Africa will become an unstoppable economic force, capable of feeding itself and the rest of the world for good measure. That is the future scope for Africans to shape in their own interests and for their own economic ambitions.

 

Antares Vision Group Acquires ACSIS

AVG Chairman & Co-CEO Emidio Zorzella says the acquisition will allow Antares Vision Group to enter the multi-billion-dollar returnable asset management market.

Reno, Nevada, Feb. 15, 2022 (EINPRESSWIRE).  Antares Vision Group (AVG), a leading global provider of hardware and software track and trace solutions and one of the major players in inspection systems and smart data management, today announced that it had acquired ACSIS Inc. through its fully controlled company rfxcel for an enterprise value of $12 million.

Founded in 1996, ACSIS has been providing solutions and services to Fortune 1000 manufacturing companies with some of the most complex and highly regulated supply chains in the world for more than 20 years. It delivers innovative software solutions and services to companies with complex warehouse, distribution, and packaging challenges, assists with their data collection requirements for track and trace and inventory optimization through their supply chains, and delivers seamless integration of information to their ERP systems. ACSIS has had zero churn among its Top 10 customers, which include DuPont, Cintas, BIMBO, Hershey and Coca-Cola. AVG will retain ACSIS’ highly experienced and proven executive team.

“The ACSIS acquisition will further strengthen our unique end-to-end solution for the digital supply chain,” rfxcel CEO Glenn Abood said. “It will provide new customers and allow us to enter into new industry verticals, as well as into the relevant returnable asset management market, extending our presence in the United States.”

ACSIS CEO Jeremy Coote said the acquisition brought together industry-leading organizations and technologies. “For more than 20 years, our incredibly talented team has been at the forefront of creating some of the most sophisticated supply chain visibility solutions for manufacturing companies around the world,” he said. “The combination of Antares Vision Group’s world-class talent with ACSIS technology, domain expertise, and commitment to innovating supply chain ecosystems will help ensure our success in an increasingly competitive industry.”

With its deep domain expertise in data collection and serialization, ACSIS in 2019 launched the ACSIS Cloud Platform, a next-generation cloud-based supply chain visibility platform that spans data collection to business process to real-time analytics and uniquely enables personalized, private supply chain edge ecosystems. The ACSIS Cloud Platform solves the toughest supply chain visibility challenges, including:

Product traceability: item-level tracking using serialization, barcodes, RFID, and other sensors; edge data collection; visibility across multi-partner ecosystems to ensure regulatory compliance, improve public safety, and enable sustainable supply chains

Returnable asset management: tracks returnable transport items (RTIs) across the extended supply chain in real time to deliver accurate inventory status; ensures compliance and efficiency; controls shrinkage and ensures proper maintenance and inspection of RTIs; predicts demand to support improved planning and customer service

Partner collaboration: integrates with partners across operating ecosystems; delivers real-time supply chain and production visibility; creates more transparent and agile supply chains; maintains common enterprise standards; ensures consistent serialization data and uniform product labeling

About Antares Vision Group

Antares Vision Group is an outstanding technology partner in digitalization and innovation for enterprises and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection. Antares Vision Group is a technological enabler of supply chain transparency and sustainable transition to protect business competitiveness and the uniqueness of each country. It provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials and production to distribution to the consumer), with integrated data, production and supply chain management, also achieved through the application of artificial intelligence and the use of blockchains.

Antares Vision Group is active in the life sciences sector (pharmaceutical, biomedical devices, and hospitals), in the beverage, food, and cosmetics industries, and has potential in other sectors. The world leader in track and trace systems for pharmaceutical products, it provides major global manufacturers (more than 50 percent of the Top 20 multinationals) and numerous government authorities with solutions to monitor their supply chains and validate product authenticity.

Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from May 14, 2021, in the STAR segment of the Mercato Telematico Azionario (MTA) (electronic equity market), Antares Vision Group recorded a turnover of Euro 162 million in 2020, operates in 60 countries, employs approximately 1,000 people, and has a consolidated network of more than 40 international partners. For more information, visit antaresvision.com and antaresvisiongroup.com.

About rfxcel

Part of Antares Vision Group, rfxcel has a long history of providing leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, protect their products and brand reputations, and engage consumers. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s Traceability System to power end-to-end supply chain solutions in track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. Founded in 2003, the company is headquartered in the United States.

Uzbekistan ASL BELGISI Update: Deadline for Pharma Serialization Extended

On February 7, 2022 — just 10 days after we posted our Uzbekistan ASL BELGISI update — the country’s State Tax Committee announced that it was “extending the timeframe for the phased introduction of mandatory digital markings” of pharmaceutical products.

The requirements were originally scheduled to take effect on February 1.

The extension was announced in a letter signed by Mubin Mirzaev, the first deputy chairman of the State Tax Committee. A new deadline was not stipulated, so the country’s serialization scheme for pharmaceuticals is effectively on hold until further notice. The letter did not mention 2022 deadlines for other regulated product categories (e.g., tobacco products; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks).

Delay or not, we expect the serialization and labeling requirements, which are based on Russia’s Chestny ZNAK system, to remain the same. Read our Uzbekistan ASL BELGISI update for more details about the regulations.

More provisions for Uzbekistan ASL BELGISI from the State Tax Committee

Deputy Chairman Mirzaev’s letter outlined two provisions:

      • A provision to instruct the State Tax Committee and CRPT Turon, which operates Uzbekistan ASL BELGISI, to submit proposals to the country’s Cabinet of Ministers for a system to recognize marking codes from other countries, “primarily markings applied [in] the territory of the Russian Federation.”
      • A provision to “implement a mechanism for electronic registration of non-resident foreign manufacturers of pharmaceutical products with the tax authorities.” Manufacturers would be assigned a non-resident taxpayer identification number (TIN) and would have to obtain a non-resident electronic digital signature (EDS).

The letter also said that the “norms for amending the Technical Regulations for the production of pharmaceutical products were transferred from the project for labeling ‘household appliances’ to the project for mandatory digital labeling of pharmaceutical products.”

As we wrote in our Uzbekistan ASL BELGISI update, a pilot for appliances began on July 1, 2021, and mandatory labeling is being introduced in phases. Vacuum cleaners, refrigerators, freezers, washing machines, TVs, and monitors were required to be labeled beginning December 1, 2021.

Final thoughts

The Uzbekistan ASL BELGISI delay illustrates a truth about supply chain regulations: Deadlines change. All the time. Announcements like the one we talked about today should never come as a surprise or catch you off guard.

The good news is that deadline changes are not the end of the world. What’s important is for you to have a supply chain solution that meets established standards, such as the world-leading GS1 standard. If your solution is fast, flexible, scalable, and automated — like our Traceability System — you will be ready to comply and keep your supply chain moving. All the time.

We’ll continue to monitor Uzbekistan ASL BELGISI as we do with other supply chain regulations. In just the last two weeks or so, we’ve written about the Africa supply chain (first of a two-part series), Egypt’s pharmaceutical regulations, Russia Chestny ZNAK requirements for beer and dietary supplements, the United Arab Emirates’ “Tatmeen” platform, and the U.S. Drug Supply Chain Security Act (DSCSA). Count on us to keep you informed about regulations around the world.

And contact us if you have any questions or want to see our solutions in action. Our digital supply chain experts are always here to listen to you, help you evaluate your needs, and work directly with you to design a solution customized for your business.