As I was preparing today’s RxTrace essay on Friday I received notice from GS1 Healthcare that China had posted draft guidance for comment for a new pharmaceutical traceability system. I dropped everything and translated the three documents into English for RxTrace subscribers and GS1 Healthcare members to use.
The explanation provided by the China Office of the State Drug Administration for the drafts translates to:
“The Office of the State Drug Administration publicly solicits opinions on the ‘Guiding Opinions on the Construction of Drug Informationization Traceability System (Draft for Comment)’.
“Released on August 24, 2018
“In order to implement the ‘Opinions of the General Office of the State Council on Accelerating the Construction of Traceability System for Important Products’ (Guo Dang Fa  No. 95) and the Opinions of the Food and Drug Administration on Promoting the Retrospective System for Food and Drug Manufacturers (Food and Drug Administration) Supervisor  No. 122), further promote the construction of drug traceability system, establish a traceability system for drug information traceability that can be traced and traced, and the State Drug Administration drafted the guidance on the construction of drug information traceability system ( ‘Consultation Draft’), is now open to the public for comments. Please send your comments to the State Drug Administration (Pharmaceutical Supervision Department) by fax or email before September 20, 2018.
You will find this page at http://cnda.cfda.gov.cn/WS04/CL2051/330005.html. Of course, the page and the documents it contains are all in Chinese. But as an RxTrace subscriber, you can download my Google Translate English versions here:
- “Guidance on the Construction of Drug Information and Traceability System”
- Attachment 1: “National Drug Regulatory Information Standard”
- Attachment 2: “Drug Traceability Code Coding Requirements”
Be careful with these translations. They aren’t perfect and they could easily lead you astray. If you are striving for compliance, then get ahold of a professional translation. In this case, you get what you pay for. I’m providing these “as is”, with no claim to accuracy. In fact, the only guarantee I can give you is that there are certainly inaccuracies in there somewhere. I just don’t know where and neither do you.
Unfortunately I spent enough time refining the translations in important spots that I wasn’t left with enough time to offer my full analysis, so that will have to wait until another RxTrace essay. But here are a few early thoughts.
THIS IS BIG NEWS
China is back in the game. They call it “guidance”, but I’m pretty sure this is a regulation. If it’s not, then they will follow it up with a regulation that refers to these guidance documents.
The only date that appears in the three documents is where it says that “At the end of 2022, the complete coverage of the drug information and traceability system [will be] basically complete”.
China is looking for comments before September 20 to improve these documents. That’s a good sign that they are interested in creating a traceability system that stakeholders can implement. We’ll have to see just how willing they are to listen to those comments. GS1 Healthcare has already announced their intention to develop and submit comments. That should be very interesting to read.
It appears that China expects the industry to create (and fund) traceability systems and ensure that they are interoperable. The government will apparently supply the Drug Traceability Service Platform and other assistance.
The Drug Traceability Code is not well defined, but each sales packaging unit “at all levels” must be marked with one. The code must be unique, no less than 10 characters, composed of numbers, letters and symbols, and it must be associated with:
- The name of the drug listing license holder
- The name of the drug manufacturer
- The generic name of the drug
- The drug approval number
- The drug standard code
- The dosage form
- The formulation specification
- The packaging specification
- The date of manufacture
- The batch
- The expiration date, and
- The [unique serial number] (‘unique serial number’ is my best guess of the meaning of the words produced by Google Translate here)
If that last data element isn’t correct, then the document explicitly states, “The drug traceability code should include the serial number code segment of the product”. And finally, the drug traceability code should include a check digit to verify the correctness of the code.
This appears to define a number of the data elements that must make up the Drug Traceability Code but it’s not a very specific definition. Are they leaving it up to each company to define their own version of a code, as long as it conforms to the above? If so, that’s not going to work. Are they offering an initial proposal for a standards-based approach, but they aren’t well versed in GS1 or other global standards? Maybe. But if I were GS1, this description would make me pretty nervous. I’d have lots of comments, warnings and recommendations. They need to clearly define the code.
The size of China’s drug market is fourth, after the US, the EU and Japan, but it is growing very fast. Getting this right will be incredibly important toward ensuring a smooth, efficient and protective supply chain there. This one will be very interesting to watch. Stay tuned.