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 Then last summer, a new government agency, the National Medical Products Administration (NMPA), posted three draft guidance documents for review and comments (see “China Posts New Draft Pharma Serialization Guidelines”).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As I was preparing today’s RxTrace essay on Friday I received notice from GS1 Healthcare that China had posted draft guidance for comment for a new pharmaceutical traceability system.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
Medical device manufacturers have a choice of standards to use when identifying their products for the U.S. market. The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose. So far, three organizations have been FDA-accredited: HIBCC, ICCBBA and GS1.
ICCBBA has a lock on the identification of Continue reading GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care
Last week SAP announced the availability of their brand new software module they are calling “SAP Advanced Track and Trace for Pharmaceuticals”, or ATTP. Pharmaceutical Commerce magazine published an article about it recently that provides the details of what is contained in this new module. The same issue contained a sponsored article from SAP about the module. As long-term readers of RxTrace know, I do not endorse specific products and I rarely even write about specific products. This essay is not an endorsement— Continue reading SAP Makes Bold Move Into Pharma Traceability
Last week, Rx-360, a pharma supply chain consortium aimed at patient safety through a secure supply chain, quietly published the white paper on Traceability Data Exchange Architecture (TDEA) (see “Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture”).
This is a new addition of major importance to the thin collection of public resources companies have available to understand the scope and the specifics of pharma serialization and traceability regulations around the world—and that’s just the first half of the document. In fact, that half is so complete and well written that it should be downloaded and read immediately by anyone facing those regulations anywhere in the world…especially if Continue reading InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper