China FDA lays down new guidelines on bioequivalence for generics

China FDA has said that generic drugs need to show bioequivalence to the related branded products, adding that the current use of locally made generics will no longer suffice. 

  China FDA's Bi Jingquan  

CFDA Commissioner Bi Jingquan signaled the push in January and repeated it in late February, marking that the quality of generic drugs would be a priority for the regulator in 2016.

The latest note on the requirement was released last week, citing a detailed circular that was issued in Chinese language.

"Pharmaceutical companies have been ordered to make sure the quality and efficacy of their drugs are on par with brand-name drugs, a move that aims to improve the nation's pharma industry," the CFDA said in a release that carried an English-language story from state-run news agency Xinhua.

"According to a circular issued by the State Council General Office, generic drugs already available on the market should be assessed on whether they are consistent with brand-name drugs, and if they could be used clinically."

However, there remains some time before full implementation with generics approved before October 2007 slated to meet the terms by the end of 2018. For drugs that face clinical trials, the deadline is 2021. Local drug firms have resisted past efforts to use branded products as the reference in quality control.

But a crackdown on quality that began last year in China has already seen dozens of firms withdraw generic candidates up for approval. CFDA has also said that firms that follow the new standards will be able to cite such testing on the drug label.

- here's the note from China FDA

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