1 EU requirements

The European Union (EU) has a harmonized legal framework for the packaging and labeling of medicinal products, which is based on the Directive 2001/83/EC and its amendments, and the Regulation (EC) No 726/2004. This framework requires that the packaging and labeling must be clear, legible, indelible, and in the official language or languages of the member state where the product is marketed. Furthermore, it must include information such as the name of the product, active substance, strength, pharmaceutical form, route of administration, batch number, expiry date, name and address of the marketing authorization holder, and any special storage or disposal conditions. Additionally, a package leaflet with detailed information on the product must be included as well as a unique identifier (a 2D barcode or a matrix code) and an anti-tampering device on the outer packaging. This is part of the EU Falsified Medicines Directive (FMD), which aims to prevent counterfeit medicines from entering the legal supply chain.

2 US requirements

The United States' regulatory system for the packaging and labeling of drugs is based on the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Code of Federal Regulations (CFR), and the guidance documents issued by the Food and Drug Administration (FDA). The US requires that the packaging and labeling of drugs must be accurate, truthful, and not misleading, and comply with FDA-approved labeling. This includes the established name of the drug, its active ingredient, quantity, dosage form, route of administration, lot number, expiration date, name and address of the manufacturer or distributor, special storage or handling instructions, a National Drug Code (NDC) number, a barcode or radiofrequency identification (RFID) tag on the packaging, as well as a prescribing information (PI) or patient package insert (PPI) with detailed information on the drug's indications, usage, dosage, warnings, precautions, adverse reactions, drug interactions. All of this is part of FDA's track-and-trace system which aims to enhance security and efficiency in the drug supply chain.

3 China requirements

In China, the packaging and labeling of pharmaceutical products must adhere to the Drug Administration Law (DAL), the Regulations for the Implementation of the Drug Administration Law (RIDAL), and the standards and guidelines issued by the National Medical Products Administration (NMPA). These requirements include being clear, legible, durable, and in Chinese language; including the name of the product, active ingredient, strength, dosage form, specification, batch number, production date, expiry date, name and address of manufacturer or importer; including a package insert with detailed information on the product; and having a serial number or QR code on the packaging as part of the NMPA's electronic drug supervision system. This system is designed to improve traceability and quality control of pharmaceutical products.