Pharma Regulatory Requirements in China
The Chinese National Medical Products Administration (NMPA) published a set of documents on April 28, 2019, to clarify the country’s new serialization code. The documents cover certain Chinese pharma regulations that range from coding requirements to event reporting guidelines.
These documents are extremely valuable because they provide guidance for an otherwise complicated process. They state that manufacturing authorization holders must build a traceability system, which can be created in-house or by a third party. In order to trade at an item level, issuing agencies must create a serial number generation strategy to ensure one-of-a-kind traceability codes.
Chinese Pharma Reporting
The new serialization code has put new methods of reporting in place in order to build a more transparent traceability system. First, prior to serialization, manufacturing authorization holders (MAHs) must report their serial number generation strategy or the third-party generator that is managing the strategy. There is no obligation to request/receive serial numbers from a central or state-controlled source, provided that numbering schemes are compliant. This differs markedly from previous Chinese systems and allows manufacturers much more control over the software solutions they use.
Furthermore, information generated and reported is now also exchanged with supply chain partners, who must report their own data to the government.
Chinese Pharmaceutical Coding Requirements
New Chinese pharmaceutical coding requirements are made for current manufacturing needs, but are also forward-looking to anticipate future supply chain scenarios. In fact, the NMPA advises that drug traceability strategies should incorporate current and future manufacturing and production needs.
According to the new Chinese pharma regulations, the drug identification code, product identification code, and drug traceability code must include the specific information below.
Drug Identification Code
This code must identify:
- The license holder
- The generic drug name
- The manufacturer
- The formulation
- The dosage form
- Specifications
- Package specifications
Production Identification Code
This code must provide the drug manufacturing information, which is data about the drug and its properties during the manufacturing process.
Drug Traceability Code
The new coding requirements state that a drug traceability code:
- Can use China’s proprietary 20-character Drug Electronic Administration Code (DEA Code/eCode) in a linear barcode
- Can use codes that comply with the ISO/IEC 15459 Series standard, such as GS1 GTINs, in a 2D DataMatrix code
- Is used for unit-level tracking
- Includes the Drug Identification and Production Codes
- Must be included in some compliance reports
Chinese Life Sciences Printing Regulations
The new pharmaceutical regulations in China also include changes to printing regulations for the life sciences. First, all codes must be human- and machine-readable. China’s eCode uses a linear 1D barcode, while the ISO-compliant codes can use a 1D linear barcode, a 2D DataMatrix code, or an RFID tag. Furthermore, the printing regulations also state that the following must be included:
- Batch & serial number
- Production date
- Pharmaceutical form
- MAH info
- Use-by date
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