China's API and drug manufacturing industries and their regulatory oversight are often painted as backward compared with the western drug manufacturing industry. But China's State Food and Drug Administration (SFDA) has set out new rules and a three-year plan that could move it ahead of the U.S. when it comes to monitoring drugs through the supply chain.
The SFDA updated its Good Supply (Distribution) Practices (GSP) rules which go into effect June 1 and are to be phased in over three years, explains Regulatory Focus. Among the provisions are requirements that companies use bar codes, electronic monitoring and standardized documentation to trace drugs through the supply chain. A rough Google translation of the document says that it sets out, among other aims, to improve cold-chain supply, storage and delivery.
The rule comes even as there are renewed calls for the U.S. to institute a track and trace system. An FDA-financed report not only calls for a national electronic tracking system, but it also says the U.S. needs to get a tighter regulatory grip on secondary wholesalers. The report from the Institute of Medicine (IOM) cited the recent discovery of counterfeit versions of Roche's ($RHHBY) Altuzan, the trade name in Turkey for the cancer drug branded Avastin in the U.S., as proof that the U.S. needs better protections. It points to the fact that many drugs and APIs come from countries like China where oversight is considered lax.
Proponents of having the drug industry institute some form of track and trace had inserted plans for a program in the proposed FDA user fee legislation last year. But it got cut out of the legislation at the last moment when lawmakers were unable to agree on details between what the FDA was seeking and what the industry was willing to accept.
The SFDA document calls China's distribution system "chaotic" and says documents setting out the quality of the drugs should accompany them through the supply chain. That kind of an improvement will increase "corporate responsibility for quality awareness," the announcement explains. Companies that don't get all of the new systems in place by 2016 will have to shut down.
- see the Regulatory Focus story
- here is the SFDA document (Chinese)