Investigation and countermeasures to the current status of the generics quality consistency evaluation

Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2015, Vol. 20 ›› Issue (1): 118-120.

Investigation and countermeasures to the current status of the generics quality consistency evaluation

YU Shan-shan¹, ZHANG Zheng-fu², LI Zheng-qi²

¹Anhui Center for Food and Drug Evaluation and Certification, Hefei 230052, Anhui, China;
²Center for Certification of Drug, China Food and Drug Administration, Beijing 100061, China

Received:2014-04-09 Revised:2014-07-17 Published:2020-07-20

Abstract

Abstract: In order to improve the quality of marketed generic drugs and eliminate those unqualified in either intrinsic quality or clinical efficacy, the program of “quality consistency evaluation for generics” has been started by the China Food and Drug Administration. Based on the investigation into the current status of domestic generics, we explored the factors restricting the evaluation of quality consistency for generic drugs, and eventually put forward particular countermeasures for the reference of industry and supervision department.

Key words: generic drugs, quality consistency evaluation, current status, countermeasures

CLC Number:

YU Shan-shan, ZHANG Zheng-fu, LI Zheng-qi. Investigation and countermeasures to the current status of the generics quality consistency evaluation[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2015, 20(1): 118-120.

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