Drug Serialization Requirements in China: New Guidance Documents
Last year, Chinese authorities published new regulations providing for the development of a new national drug traceability system by 2022 to replace the suspended former system. Developed by Alibaba’s AliHealth unit, it was deemed uncompetitive.
On April 28, 2019 the Chinese National Medical Products Administration (NMPA) published two documents to clarify some of the requirements set out in the new drug traceability code.
• Encoding requirements for drug traceability code
• Guidelines for drug traceability information system construction
These guidelines are welcome as, with the new system announced last year, manufacturing authorization holders (MAHs) are now responsible for building a traceability system, either developed inhouse or provided by a third party. ‘Issuing agencies’ (entities that generate the serial numbers) now need to define a serial number generation strategy that guarantees unique drug traceability codes at trade item level.
Coding and Serialization Requirements in China
Item level identification and traceability in China rely on three codes:
The drug traceability code is used to uniquely identify a sales package unit at each level of packaging, consisting of a list of numbers, letters, and/or symbols.
The drug identification code is a unique code used to identify a drug in regard to license holder, manufacturer, generic drug name, dosage form, formulation specifications, and package specifications.
The production identification code is a code used to identify data about the drug during the manufacturing process.
NMPA (Chinese National Medical Products Administration) advises ‘issuing agencies’ to define a drug traceability code generation strategy that takes into account current production needs and processes as well as future requirements (i.e. in terms of scalability, supply chain partners, etc.). The code can contain alphanumeric and special characters, should contain a check digit and be compliant with either of the 2 following:
- 20 characters with the first 7 characters being the drug identification code
- International ISO standards i.e. ISO/IEC 15459
Printing requirements for the Chinese market
Information needs to be printed in machine and human readable format, but requirements are relatively flexible, especially for the human readable data.
When it comes to machine readable data, companies can choose whether they use a linear bar code, 2D data matrix or RFID tag. Product and item-related information including MAH information, pharmaceutical form, date of production and use-by period, batch and serial number should be comprised in the machine-readable data.
Reporting requirements for pharmaceutical products
Before starting serialization activities, the MAH will have to report its serial number generation strategy as well as the entity generating the codes for them if it does not create them itself. Traceability information will have to be exchanged among trading partners along the supply chain and reported into the government system and such information kept for a minimum of five years.
Chinese authorities rarely publish official English versions of regulations but we will keep analyzing new information coming from China with an update on how the system shall look like coming soon.