Monday, March 31, 2008

More on the Heparin Saga

Chinese quality stinks!!! Chinese drug regulation stinks!!!


"issued a plea"...

"safeguarding the legality, quality and safety of active pharmaceutical
ingredients (APIs)" is ultimately the responsibility of the importing

These people are unbelievable...

China's drug regulatory authority is finally responding to curb its damaged reputation by urging its local authorities to take a more proactive role in stemming what is fast becoming a global heparin contamination, sparked by material sourced in the country.

According to Chinese media reports, the State Food and Drug Administration (SFDA) issued a message on its website urging its regional offices to boost their supervision of the production methods of heparin manufacturers in their locality.

The watchdog has also urged heparin producers to source their raw heparin from registered suppliers only, and issued a plea to heparin manufacturers to ensure they are producing the material in accordance with the approved standards.

In addition, the SFDA warned manufacturers that they must take the initiative to closely follow the clinical effects of their products that are on the market and if any problems are linked back to their manufacturing facilities, they must halt production immediately and recall any implicated products from the market.

Moreover, the agency told raw heparin suppliers to tighten their management and quality checks of raw and supplementary materials. The SFDA's latest actions indicate a softening of the stance on drug exports from the country that it took this time a month ago, when it effectively sent out a message to the world of "buyer beware".

link to full article

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