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 on the China Food and Drug Administration (CFDA) website that refers to the recent adoption of some modifications to the CFDA Pharmaceutical Quality Management Specification.  Based on the Google Translate translation it appears that this specification includes the high-level quality requirements for establishments that procure, store, sell, and transport drugs in China.  This includes a wide range of requirements designed to ensure that quality management processes are followed by each establishment in the supply chain.  These recent modifications to the specification were promulgation as of July 13, 2016.

As I said, there are lots of changes to the specification.  One of those many changes was to add the ability to trace drugs “back”.  It is also pretty clear that no specific details were included to explain how that might be done.  This specification is clearly not intended to provide those details, but it is an indication that China has not given up on drug traceability.  Until the CFDA publishes the details of their updated requirements, the old regulation is apparently still suspended.

A number of people have asked me for guidance on how they should serialize and report drug shipments targeting China during the apparent “suspension” of the previous regulation.  I don’t know, but when I learn something I have confidence in, I will let you know.  Until then, your best avenue is to seek guidance from your local trading partner or China-based trade association.