In late August, the China National Medical Products Administration (NMPA) issued three new drug and vaccine traceability guidance documents. Then in mid-September, they issued five draft documents for comment related to the data exchange protocol for drug traceability. Based on those publications, it appears that China really is accelerating their move toward traceability of drugs (see “China Commits To The Digital Future In Healthcare, Including Pharma Traceability”).
It’s not hard to find out when new documents are release by NMPA—GS1 Healthcare keeps pumping out the notices to its members whenever that happens—but it is hard to keep up with understanding exactly what is going on in China…the big picture. I’ve used Google Translate to translate some of the older documents but have not had time to do anything other than some quick ad hoc translating of paragraphs in some of these more recent documents so I can see what each one focuses on. I’m particularly interested in dates but those published in the last year do not seem to include any. Or did I miss the one document that ties them all together with a timeline? You’d tell me if I did, right?
What I should do is take a few days and do a full document translation of each of the 8 to 10 documents that have come out in the last year, then sit down and read them in sequence so I might be able to stitch together that big picture. Until I have time for that, here are the links to the pages that have links to the August and September documents.
The August release includes the following documents:
- Basic technical requirements for drug traceability system.pdf
- Basic Dataset for Vaccine Traceability.pdf
- Basic technical requirements for vaccine traceability data exchange.pdf
The September release includes the following documents:
- Traceable basic data sets for drug manufacturers (Draft for Comment).pdf
- Traceable basic data set of drug management enterprises (draft for comments).pdf
- Traceable basic data sets for drug use units (draft for comments).pdf
- Drug traceability consumer inquiry basic data set (draft for comments).pdf
- Basic technical requirements for drug traceability data exchange (draft for comments).pdf
Most of these documents are XML and JSON data set specifications, as the titles imply. Each of those documents explain how companies will need to communicate with the government’s central or regional repositories. The data exchange appears to be event-based so as a collection of specifications, they appear to fill the role of GS1’s Electronic Product Code Information Services (EPCIS) standard specification, maybe combined with GS1 US’ DSCSA Implementation Guide, but with less explanation.
If you are a drug company doing business in China, you will need to have these documents translated and study them.