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.Continue reading China Sets Aggressive Date for Vaccine Traceability
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”).Continue reading China Inches Closer To Another Pharma Serialization Mandate
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.Continue reading China Commits To The Digital Future In Healthcare, Including Pharma Traceability
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”.Continue reading China: NMPA Drug Traceability Guidance
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: Continue reading China Posts New Draft Pharma Serialization Guidelines
Over the last few weeks, the pharma serialization and tracing landscape has begun to shift in China. The China Food and Drug Administration (CFDA) announced a new use for an existing “National Drug Code” in Public Notice 2017-1 that, according to Google Translate (a helpful but very imperfect translator), will be referred to as the “Bit Code”. In addition, a new notice has appeared on the AliHealth-hosted web portal that drug companies have been using for the last seven years or so to obtain serial numbers for their drug packages. Automated translation tools leave too much to speculation so companies should not use them for compliance purposes. However, here are my thoughts/speculation on what is happening. Continue reading The Intrigue Contained In The New China Drug Code
China once had one of the most aggressive pharma serialization mandates of any market. Their compliance timeline began in 2007 with a list of “essential drugs” and ended in January of this year when, effectively, all drug packages were required to carry a unique serial number. Shortly after that milestone the government suspended that requirement, pending a new regulation. Since that time the China Food and Drug Administration (CFDA) has posted several documents related to their new plans (see “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”). Last month a new notice from the CFDA Continue reading China’s Retreat From Pharma Serialization: Will This Become A Global Trend?
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.
With all that said, a few weeks ago a notice appeared Continue reading China Adds Traceability Requirement To CFDA Drug Quality Management Specification