For a few years now, China has been building a library of documents that define standards for traceability, but no dates have appeared in any of them (see “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”, “China Posts New Draft Pharma Serialization Guidelines”, “China: NMPA Drug Traceability Guidance”, “China Commits To The Digital Future In Healthcare, Including Pharma Traceability” and “China Inches Closer To Another Pharma Serialization Mandate”). In a new posting on their website yesterday, the China National Medical Products Administration (NMPA) provided a notice of aggressive deadlines for vaccine traceability. Let’s take a look at it because a vaccine traceability mandate is probably a herald of a near-term future pharmaceutical traceability mandate.
The notice can be found here. I use the Google Chrome browser and it offers to translate the text to English (after about 30 seconds). If it doesn’t for you, then you will have to find an online translator to do it. Basically it says that the standards for vaccine traceability have already been established through the guidance documents I referred to in my essays above, and all that is left is for the federal and provincial governments to implement their portions of the government’s side, and for marketing authorization holders (MAH) to implement their side of the system. Piloting is currently going on in seven cities, including Beijing and Shanghai. They will complete their regional connections to the State Drug Administration’s (a division of NMPA) vaccine traceability service platform and supervision system (referred to as a “collaborative platform”) by the end of 2019. It’s unclear if vaccine manufacturers are participating in the pilot.
The notice says that “…vaccine information traceability systems should be established through the country to achieve traceability of the entire process of all marketed vaccines and ensure that the smallest packaging unit of the vaccine is traceable and verifiable…” by March 31, 2020. That appears to include the work vaccine MAHs would need to do to connect to the collaboration platform.
The new notice from the NMPA has been rumored for a few months so to some, it isn’t a surprise. The serious problem of vaccine counterfeiting in China became a true scandal in 2015 when it was discovered that a mother-daughter-run crime syndicate had been selling counterfeit vaccines for immunizing children in 20 of China’s 26 provinces for several years. It included 300 illegal distributors.
Coincidentally in October 2019, China’s President Xi Jinping announced that China would focus on blockchain technology (not just for vaccines or pharma traceability but generally). The problem and its potential solution have quickly come together. The attention the government has given to counterfeit vaccines since the problem was exposed triggered the development of a blockchain-based vaccine traceability solution by a company in China called VeChain. They make it sound like they have the inside track with the government and they may very well have. We’ll have to watch developments in the next few months to know for sure. But odds are, China’s solution to vaccine traceability will be/is based on blockchain technology. Can blockchain-based pharma traceability be far behind?
No new RxTrace essays for the rest of the year. Happy Holidays to everyone. Watch for RxTrace news in January!