Registration of Proprietary Chinese Medicines > Requirements for test laboratories

Laboratories conducting the product safety tests, product quality tests, principal pharmacodynamic tests and general pharmacological tests for pCms must have met the requirements set by the International Standardization Organization (i.e. ISO/IEC 17025), Good Laboratory Practice (GLP), or any other laboratories which are accepted by the Chinese Medicines Board. Other municipal Institutes for Drug Control in China that are recognized both by the State Food & Drug Administration (SFDA) and the Chinese Medicines Board will also be accepted.

Centres conducting the clinical trials for pCms must have met the requirements of "Good Clinical Practice for proprietary Chinese medicines" or other equivalent standards. Other clinical trial centres in China that are recognised both by the SFDA and the Chinese Medicines Board will also be accepted.

  1. For information on local laboratories providing pCm tests accredited with ISO/IEC 17025, please refer to Information on Local Laboratories (For reference only).

  2. The list & relevant information of municipal Institutes for Drug Control in China that are recognized both by the State Food & Drug Administration (SFDA) and the Chinese Medicines Board.(Chinese Version Only).

 

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