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Egypt Pharmaceutical Supply Chain: News and Regulations

If you follow our blog (and we know you do), you’ve probably detected a theme over the last few days: global pharma compliance. We’ve written about Russia Chestny ZNAK, United Arab Emirates Tatmeen, Uzbekistan ASL BELGISI, and our rfxcel DSCSA Compliance Library. Today, we’re looking at the Egypt pharmaceutical supply chain. Let’s get started.

Notable news about the Egypt pharmaceutical supply chain

Last August, Egyptian Prime Minister Mostafa Madbouli told a gathering of government officials that the country would prioritize the “localization” of the pharma industry. He said President Abdel Fattah al-Sisi had tasked the government with developing an executive plan to this end.

It seems to be working: the Egypt pharmaceutical supply chain is enjoying strong growth. Last month, Egyptian Drug Authority (EDA) Director Dr. Tamer Essam said the country’s pharma exports had risen to 35 percent, an all-time high. “There is no medicine in the world or vaccine that is not manufactured in Egypt,” he said. In February 2021, the EDA announced it was launching an export subsidy initiative and had begun reviewing and updating all export procedures to ensure they complied with global regulatory requirements.

In April 2021, the head of the General Division of Drug Traders at the Federation of Egyptian Chambers of Commerce (FEDCOC), Ali Auf, said Egypt produced about 85 percent of its pharmaceutical needs domestically (and imported only 15 percent).

Auf made these statements two days after President Sisi inaugurated Gypto Pharma City, which embodies Egypt’s drive for pharmaceutical self-sufficiency. Situated on roughly 44.5 acres in Khanka, about 20 miles from Cairo, it’s one of the largest “medicine cities” in the region. It has facilities for production, administration, industrial services, and networks.

Egypt envisions Gypto Pharma 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.”

The Egyptian Pharmaceutical Track & Trace System

The goal of the Egyptian Pharmaceutical Track & Trace System (EPTTS) is end-to-end traceability and product authentication across the Egypt pharmaceutical supply chain to reduce counterfeits, increase efficiency, and protect consumers. Appropriately, this dovetails into what the government has said about Gypto Pharma City — that it will “help citizens obtain high-quality and safe pharmacological treatment, end monopolistic practices, and control the prices of medicines.”

At first, the Ministry of Health and Population managed EPTTS; however, Law No. 151 of August 2019 essentially transferred those duties to the newly formed EDA. (It also created another organization, the Egyptian Authority for Unified Drug Procurement, a “centralized procurement and supply interface.”) The EDA was initially affiliated to the prime minister, but Presidential Decree 18/2020 of January 2020 gave it more autonomy.

The EDA “inherited” three organizations from the Ministry of Health and Population:

    • The Central Administration of Pharmaceutical Affairs (CAPA) registers pharma products, issues licenses for the establishment of pharma entities, and licenses the import and export of pharma products. It’s also responsible for regulating prices and evaluating clinical trials and studies of drugs.
    • The National Organization for Drug Control and Research (NODCAR) works to ensure the quality, safety, and effectiveness of pharma products, cosmetics, and insecticides. NODCAR must certify every pharmaceutical product before it can be registered, marketed, advertised, distributed, imported, or exported.
    • The National Organization for Research and Control of Biologicals (NORCB) monitors, inspects, and releases all biological products for human or animal use, such as vaccines.

Like most countries, the Egypt pharmaceutical supply chain follows GS1 labeling standards, characterized by Global Trade Item Numbers (GTINs), Serialized Global Trade Item Numbers (SGTINs), 2D DataMatrix codes, GS1-128 barcodes, serial shipping container codes (SSCCs), and Global Location Numbers (GLNs). It is also using GS1’s Electronic Product Code Information Services (EPCIS) standard.

Secondary packaging must be marked with a 2D DataMatrix code with the GTIN, expiry date, batch number, and a randomized serial number. EPTTS’ original plan was to require these data points to be presented in a specific sequence, but this was nixed. Cases and pallets must have a GS1-128 barcode or a DataMatrix code with the SSCC.

EPTTS requires aggregation, including maintaining the parent-child relationship, but has yet to provide details. We’re also waiting for specifics about some aspects of serialization, including if serial numbers can be reused.

For data and compliance reporting, supply chain actors are required to submit data to a GS1 Global Data Synchronization Network (GDSN) database. They must upload photos — as many as six of them — that clearly show the product packaging and other details, including the GTIN, brand name, storage instructions, country of origin, product name, and any warning statement. To date, however, the government hasn’t published specifications for communicating with the EPTTS database.

A pilot to test EPTTS was held from December 1, 2019, to January 12, 2020. Participants have shared feedback, but there hasn’t been much movement since. GS1 Egypt and the EDA are apparently still working on the implementation guidelines, which are now in their third iteration.

Final thoughts

The Egypt pharmaceutical supply chain regulations are a work in progress, and we’ll continue to follow developments and share updates when there’s concrete news.

But as we said in our overview of UAE Tatmeen, the global push for pharmaceutical traceability and serialization is continuing at a furious pace. If you’re a manufacturer, a distributor, a third-party logistics provider, a dispenser — any actor in the supply chain — waiting for Egypt or any other country to formalize their regulations is not a wise strategy. You have to have a solution now, preferably one that will work in every country.

That’s what our Traceability System does. Our supply chain experts can demonstrate in a few minutes how it automates compliance and optimizes just about every other aspect of your operations. Contact us today to see it in action. And continue following our blog. We’ll be writing more about global pharma regulations in the coming weeks (and months and years).  For example:

Russia Chestny ZNAK Track and Trace: A Refresher Course

Russia is in the midst of creating the world’s most ambitious — and strict — supply chain track and trace system. Its National Track and Trace Digital System, known as Chestny ZNAK (and sometimes translated as Honest SIGN or Honest BADGE), is on track to be fully operational in 2024. Chestny ZNAK track and trace requirements are tough, and they’ll cover virtually every type of product you can imagine.

No matter what role you play in the supply chain, you have to understand how the system works and what the regulations mandate. Let’s examine Chestny ZNAK track and trace, from its origins to what it requires.

The origins of Chestny ZNAK track and trace

On December 29, 2017, Russian President Vladimir Putin signed Law No. 425-FZ, officially inaugurating the Chestny ZNAK track and trace system. Its goal is to streamline quality control, protect against counterfeits, and monitor supply and demand and expenditure. The regulations cover 12 product categories: medicines, furs, footwear, bottled drinking water, tires, tobacco, dairy, wheelchairs, bicycles, light industry, perfumes, and photo cameras and flashbulbs.

Chestny ZNAK is run by the Center for Research in Perspective Technologies (CRPT), a public-private partnership akin to the European Medicines Verification Organization. Its principal partner, with a 51 percent stake, is business giant USM, which was founded in 2012 and has interests in many of Russia’s key sectors, including metals/mining, telecom, technology, and internet.

According to USM, Chestny ZNAK is the country’s first public-private partnership in the IT sector and the first of its kind at the federal level. Private investments totaling more than 200 billion rubles ($2.5 billion) are expected over the next 15 years.

What are the requirements?

Chestny ZNAK track and trace regulations are arguably the strictest in the world. Companies that do not comply face fines and other penalties, including “deprivation of liberty” (prison), and can in essence be banned from doing business in Russia.

The requirements vary by industry, and deadlines and labeling requirements have changed, but the fundamentals have remained constant: serialization, aggregation, unit- and batch-level traceability, crypto codes, and electronic reporting and records management.

Products must be marked with 2D Data Matrix codes with an 85-character alphanumeric sequence that contains at least four groups of information: a Global Trade Item Number (GTIN), a serial number, a verification key, and a verification code (i.e., crypto code). Furthermore, the owner of goods must create a Universal Transfer Document (UTD) at the moment of ownership, then transfer it to the CRPT.

The crypto codes are an important part of Chestny ZNAK track and trace. At first, every code had to have 88 characters, but a federal decree in August 2019 that amended the procedure for applying drug labelling codes cut the requirement to 44 characters. The CRPT issues the codes, which only authorized representatives can request/receive. rfxcel is an approved partner of the CRPT; more on that below.

For the pharma sector, it’s prudent to note that Chestny ZNAK track and trace requires over-the-counter (OTC) drugs to be labeled, scanned, and recorded in the system. This is a significant departure from the EU Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA).

These are the broad strokes of the Chestny ZNAK track and trace regulations. There are other requirements — such tracking products with Universal Transfer Documents (UTDs), which must be sent to the CRPT when ownership of goods changes — but we won’t get into those here.

How does it work?

Chestny ZNAK track and trace is a five-step process that calls for complete traceability all the way to consumers. Let’s walk through these steps.

First, the CRPT sends the manufacturer, wholesaler, retailer, or importer — referred to as “economic agents” in the regulations — a unique digital code for every product that must be affixed to the packaging. Only a CRPT-authorized representative can request codes. Every product is logged in Chestny ZNAK’s catalogue of marked goods.

In the second “logistics” step, the digital code becomes an immutable “passport” that legitimizes the product at every step of the supply chain. Every transfer of ownership must be recorded.

Next, the product arrives at the location where it will be sold or dispensed. The receiver scans the item, Chestny ZNAK receives a transfer confirmation, and it’s ready for sale.

Fourth, the product is sold or dispensed. The seller is required to have a point-of-sale cash register, a system connected to the internet that typically includes a touchscreen, a scanner to read 2D Data Matrix codes and other codes, a credit card scanner, and a printer. The product is scanned at checkout and the cash register reports to Chestny ZNAK that “the code has left circulation.” If the scanned data doesn’t match what’s in the catalogue of marked goods, the product is counterfeit or otherwise illegitimate and cannot be sold.

In the last step, the consumer takes over and becomes the final supply chain quality control checkpoint. Using the Chestny ZNAK app for smart devices, described as “your main assistant for product quality tracking and counterfeit detection,” a person scans the 2D Data Matrix code on the product and gets instant access to rich information directly from Chestny ZNAK. If a scan reveals a “violation” — meaning the product is counterfeit or not in compliance with marking regulations —  consumers can report it directly to the CRPT. They can also send questions about how the app works and suggestions to improve it

Here, we want to point out that the Chestny ZNAK track and trace app reminds us of our own MobileTraceability app, only for consumer use. Both can show the date, time, and place of production, the expiration date, and details about the product’s journey from the farm or factory to the store. Our MobileTraceability app is a powerful tool for track and trace in any industry. Check out our short video about how it works in the food and beverage supply chain.

Final thoughts

If you follow our blog or read our news, you know rfxcel is the leader in Chestny ZNAK track and trace compliance. That’s a bold statement, but we think we have the facts to back it up:

  • We’re an official integration, software, and tested solution partner with the CRPT. We’ve demonstrated that our solutions, particularly our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Chestny ZNAK track and trace requirements and ensure companies stay compliant.
  • rTS works seamlessly with Chestny ZNAK track and trace, including a Russian-language user interface that makes integration and startup much quicker.
  • We’ve prepared for Chestny ZNAK since 2018.
  • We’re one of the few providers with active implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting.

Contact us today learn more about how we can help you with Chestny ZNAK track and trace. No matter how far along you are in your preparations to meet the requirements, you should talk to us — even if you’re already working with another provider. Our powerful software ensures companies in any industry remain compliant with the complex regulations.

 

Supply Chain Visibility Can Fight Fraud in the Time of COVID-19

Earlier this month, the U.S. Food and Drug Administration (FDA) posted an update about actions it’s taking to keep fraudulent COVID-19 treatments off the market. The examples of fraud the Agency gave illustrate why all industries — not just the pharmaceutical industry — need to embrace supply chain visibility. Let’s take a look at what the FDA said and why supply chain visibility is a panacea for the problem.

Consumer vulnerability, scammers, and unproven and potentially dangerous products

The FDA’s update addressed “the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic.”

This statement reveals one reason fraud exists: consumer vulnerability. When people are confronted with a problem, especially one they feel they cannot control (such as a pandemic), some may tend to seek solutions without pausing to think them through. Peddlers of fake and substandard products are always ready to exploit this situation.

Which brings us to the scammers, many of whom use the internet to sell their bogus goods. Today, the FDA says, unscrupulous actors are claiming their products “mitigate, prevent, treat, diagnose, or cure COVID-19.” With the pandemic dominating headlines and weighing heavily on people’s minds, these quacks are only more than happy to offer unproven and potentially dangerous products.

What is the FDA doing, exactly?

The Agency has launched Operation Quack Hack to find and stop scammers. It’s located scores of phony products online, including fraudulent drugs, COVID-19 testing kits, and personal protective equipment. The FDA has issued 42 warning letters to companies making false COVID-19 claims and has sent hundreds of abuse complaints to domain name registrars and internet marketplaces, most of which have voluntarily removed the offending product pages.

One of the warning letters went to an organization selling fraudulent chlorine dioxide products as a COVID-19 treatment. When it refused to cease and desist sales of its so-called Miracle Mineral Solution, or “MMS,” a federal court issued a preliminary injunction requiring it to immediately stop distributing the product. The FDA characterizes chlorine dioxide as the equivalent of industrial bleach and since 2010 has been warning consumers about MMS and other products with names such as Master Mineral Solution, Chlorine Dioxide Protocol, and Water Purification Solution (WPS).

The FDA also intercepted and investigated a case of mislabeled COVID-19 “treatment kits” that someone was trying to import into the United States. Also, an FDA investigation led to a U.S. Department of Justice criminal complaint against a British man “who sought to profit from [the] pandemic and jeopardize public health.”

How supply chain visibility can fight fraud

Visibility means using data to gain insight into how a supply chain is functioning and to take steps to make it run more efficiently. The goal is to see everything.

A company must have systems that can gather and report data from one end of the supply chain to the other. Data should be as “rich” as possible; today, that means a digital supply chain with real-time access to unit-level data about everything from ingredients to temperature.

Here’s a rundown of how supply chain visibility can fight fraud. We’re using the pharma industry in our example, but the tenets apply to any product in any industry.

    • You know the origin of your ingredients. Supply chain visibility allows a manufacturer to verify that all the ingredients of a drug are legitimate. It can track every ingredient up until the time they’re combined to make the drug.
    • You can follow the drug’s every move: Part 1. After the drug has been manufactured, bottled, and packed into cases, you can see everywhere those cases go after they leave the plant — warehouses, stores, pharmacies, hospitals, etc. — and you can track their movements in real time. With supply chain visibility, you can anticipate traffic bottlenecks and reroute the delivery vehicle, keeping the shipment on time. You’ll also know if the delivery vehicle has been diverted from its prescribed route, which could indicate theft.
    • You know if the drug has been harmed or compromised. Supply chain visibility means you’ll be alerted if there’s a problem with the shipment. For example, if there’s been a change in temperature, light, or humidity that can affect the drug’s efficacy, or if the cases have been dropped or jolted in a way that might have damaged the bottles, packets, or vials inside. And we’ve already mentioned route diversion and theft.
    • You can follow the drug’s every move: Part 2. When the cases are separated (e.g., taken off a pallet), you can follow each one; when a case is opened, supply chain visibility lets you follow the individual bottles or packets all the way to check-out at the cash register or stocking at a pharmacy or hospital.

Final thoughts

Supply chain visibility creates an “airtight” supply chain that leaves virtually no room for unproven, potentially dangerous, fake, or otherwise fraudulent products to sneak in. And if such a product does appear, supply chain visibility means you can remove it faster. After all, when you can see everything, it’s easier to spot imposters and get rid of them.

rfxcel can provide supply chain visibility in any industry. Our signature rfxcel Traceability System (rTS) is a full-stack visibility and track and trace platform that comprises solutions that empower end-to-end supply chain visibility, including:

    • rfxcel Integrated Monitoring (rIM) is an award-winning solution that uses Internet of Things (IoT)-enabled devices to provide real-time data about 12+ environmental conditions (e.g., location, temperature, shock) of products anywhere in the world.
    • rfxcel MobileTraceability brings the power of an rTS digital supply chain to your smartphone, tablet, or other mobile device.

As FDA Associate Commissioner for Regulatory Affairs Dr. Judy McMeekin said, “It is imperative that we continue our efforts to find and prevent the sale and distribution of products that may be harmful to the public health.” Supply chain visibility is the way to do this. Contact us today to find out how we can help you.