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”).
Tesla Gigafactory 3 near Shanghai, China, June 22, 2019. Screengrab from YouTube video posted by Jason Yang.
I finally had time to finish applying Google Translate to
the document issued on May 23, 2019 by the Comprehensive and Planning Finance
Department of the China National Drug Administration (CNDA), called “State Drug
Administration: Action Plan to Accelerate
the Promotion of Smart Drug Supervision”.
I originally thought “Smart Drug Supervision” was solely related to supply
chain supervision, serialization and traceability, but that’s only a part of
their plan.
Most RxTrace readers will recall that China was an early adopter of drug traceability. Back in 2007, companies were required to begin printing unique identifiers in linear barcodes on certain drug packages. The unique identifiers had to be purchased from a government contractor. The list of drugs grew each year to the point where all drugs were effectively covered by early 2016. But shortly after that, the whole requirement was suspended (see “China’s Retreat From Pharma Serialization: Will This Become A Global Trend?” and “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”). Then last summer, a new government agency, the National Medical Products Administration (NMPA), posted three draft guidance documents for review and comments (see “China Posts New Draft Pharma Serialization Guidelines”). Finally, last month, the NMPA published two of those documents in final form, “Implemented on April 19, 2019”.
As I was preparing today’s RxTrace essay on Friday I received notice from GS1 Healthcare that China had posted draft guidance for comment for a new pharmaceutical traceability system.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.
Everyone who markets drugs in China has been watching for the publication of revised requirements for tracing drugs there since the government apparently suspended their previous requirements earlier this year. Interpreting Chinese government announcements is very hard to do. Even knowing for sure exactly what has been suspended about the previous regulation is very difficult. Google Translate does a poor job of making Chinese understandable enough to provide me with confidence.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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Everyone who markets drugs in China has been watching for the publication of revised requirements for tracing drugs there since 