Life Science Regulations around the world

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FALSIFIED AND COUNTERFEIT DRUGS AND MEDICINES ARE A REAL RISK TO CUSTOMERS’ HEALTH. AS FALSIFIED MEDICINES BECOME MORE SOPHISTICATED, THE RISK OF THEM REACHING PATIENTS INCREASES. THEY REPRESENT A SERIOUS THREAT TO GLOBAL HEALTH AND CALL FOR A COMPREHENSIVE STRATEGY AT BOTH NATIONAL AND INTERNATIONAL LEVELS.

FOR THAT REASON, GOVERNMENT AUTHORITIES ALL AROUND THE WORLD ARE DEFINING AND IMPLEMENTING REGULATIONS WITH WHICH THE PHARMACEUTICAL INDUSTRY MUST COMPLY.

Drug Supply Chain Security Act (DSCSA)

In the U.S., the Food and Drug Administration (FDA) has defined standards to secure the drug supply chain. Standardized numerical identification for prescription drug packages is now required. This is serialization.

Serialization entails marking packages with a product identifier (GTIN), a unique serial number, a lot number and an expiration date. The serialization must be done to the smallest packaging level of a product, should it be a box, a vial or a bottle, and all data must be included in a 2D Data Matrix (GS1) data carrier.

Aggregation is the next logical step and requirement of the DSCSA. All companies that have just finished implemented the serialization process are expected to undertake this next critical step by 2023.

 

The Medicines Directive (FMD) of the European Union

Understanding the EU FMD is no easy task, but this law has had a significant impact throughout the pharmaceutical and healthcare industries, affecting operations from one end of the supply chain to the other, from manufacturing to dispensing.

Pharmaceutical manufacturersparallel importers and contract manufacturing organisations (CMOs) must guarantee the authenticity of all prescription drugs by identifying individual packs and checking whether the outer packaging of medicines has been tampered with.

Wholesalers and distributors must guarantee the authenticity of prescription drugs and identify whether the outer packaging of medicines has been altered.

European hospitals and retail pharmacies are then be required to decommission prescription medications using unique identifiers before distributing them to patients.

The National Agency of Sanitary Surveillance in Brazil (ANVISA)

In Brazil, Law No. 13.410 of 28 December 2016, together with RDC 157 (Resolução da Diretoria Colegiada, Resolution of the Board of Directors No. 157), gives the pharmaceutical industry until April 2022 to implement traceability in its chain of prescribed drugs. This system must be connected to the central database called the Sistema Nacional de Controle de Medicamentos (National Drug Control System, SNCM), created by the Agência Nacional de Vigilância Sanitária (Brazilian Health Regulatory Agency, ANVISA), in order to deliver better quality and safety to the final consumer.

The implementation of traceability occurs through the serialization and aggregation of the products. This means that drugs will receive a unique identification printed on the packaging, known as the “Identificador Único de Medicamentos” (“Unique Drugs Identifier”, IUM). The IUM is made up of:

  • 2D Data Matrix encoded with Global Trade Item Number, GTIN;
  • ANVISA’s drugs registration code;
  • Serial number;
  • Expiry date;
  • Batch ID;

Serialization For Russian Federal Law No. 425-FZ

The Russian Federal Law No. 425-FZ (decree No 1556) which came into effect October 1, 2020, states that to track supply chain activity, certain pharmaceutical products must be serialized. Unlike the EU’s serialization requirements under the FMD, Russian regulations apply to a wider range of pharmaceutical products. These include:

  • Prescription medications
  • Over-the-counter medications
  • 12 Nosologies: Medications for rare diseases that are expensive to treat, such as hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, myeloid leukemia, multiple sclerosis, immunosuppressive therapy for organ transplant patients, Hemolytic-uremic syndrome, juvenile arthritis with systemic onset, and Mucopolysaccharidosis type I, II and IV.
  • Free samples

Reporting of serialized products takes place through a centralized database called the Federal State Information System for Monitoring Drug Circulation (FSIS MDC). Manufacturers must onboard with the FSIS MDC and report all serial numbers and batch numbers to the centralized system. Along with the information required by U.S. and European regulations (a GTIN and serial number), the Russian regulations call for a crypto key (four characters from the GS1 characters set 82) and crypto code (44 characters: symbols, numbers, and lowercase and uppercase letters from the Latin alphabet).

Each individual unit must be serialized with a 2D barcode that is placed on the box or bottle. This 2D code contains the following information:

  • • 14-digit Global Trade Item Number (GTIN)
  • Serial number (SN): 13 symbols of numeric or alphanumeric sequence of the Latin alphabet; can be random
  • Crypto key
  • Crypto code

CHINA’S DRUG TRACEABILITY STANDARDS

The Drug Administration Law tasked the National Medical Products Administration (NMPA) with establishing unified traceability standards and specifications for drug products. China has since adopted 10 drug traceability standards and specifications to guide relevant parties to jointly build a national Drug Traceability Information System.

 

The move helps to break down barriers between various independent systems and companies by unifying drug traceability code requirements, standardizing the basic technical requirements for drug traceability systems, defining the content and format of information companies are required to record during the traceability process, and outlining data exchange requirements.

 

On October 10, 2020, the China National Drug Administration (CNDA) made a public announcement confirming the deadline of December 31, 2020, for the drug market authorization holders to complete the construction of the traceability system and collect traceability information throughout the entire process, for products such as the national drug centralized procurement, narcotic drugs, psychotropic drugs, and blood products.

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OTHER LEGISLATION AROUND THE WORLD

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