Chinese Regulatory Agency: Drug and API Importers are Responsible for Supply Quality

GMP News
2 April 2008
 

Chinese Regulatory Agency:
Drug and API Importers are Responsible for Supply Quality

 
Although the Chinese State Food and Drug Administration (SFDA) frequently inspects API manufacturers in China and certifies them as pharmaceutical company after a successful inspection, the agency has clearly stated that "safeguarding the legality, quality and safety of APIs" is the responsibility of the importing country. That means that a pharmaceutical company importing an API and the respective regulatory agency should take a close look on the Chinese company before buying or importing any of its products. Sufficient supplier qualification and stringent quality control tests are therefore strongly recommended.
 
Special attention has to be paid with chemical manufacturers which are not registered by SFDA as a pharmaceutical company and therefore are not subject to SFDA inspection and approval. Recent incidents show that this is not an uncommon practice and might create critical quality problems.

Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

Source:
More information about the Chinese SFDA can be found here:
http://eng.sfda.gov.cn/eng/
 

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