Category Archives: China

China Posts New Draft Pharma Serialization Guidelines

As I was preparing today’s RxTrace essay on Friday I received notice from GS1 Healthcare that China had posted draft guidance for comment for a new pharmaceutical traceability system.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

The Intrigue Contained In The New China Drug Code

The CFDA “Bit Code”

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 Adds Traceability Requirement To CFDA Drug Quality Management Specification

CFDA.logoEveryone 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