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Chinese guidelines for biosimilars Posted 21/11/2014

Last update:  21 November 2014

Since 2003, the China Food and Drug Administration (CFDA) (simplified Chinese: 国家食品药品监督管理局) is the Chinese authority that oversees all drug manufacturing, trade, and registration.

CFDA is in charge of comprehensive supervision on the safety management of food, health food, and cosmetics and is the competent authority of drug regulation in Mainland China.

The Chinese Government’s establishment of a single drug regulatory authority was an important step toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies, centralized the Chinese healthcare regulatory system, and made it more transparent. CFDA now oversees all medications, both Western and Traditional Chinese Medicines (TCM), as well as advertising.

CFDA administers the Drug Administration Law, which came into effect on 1 December 2001.

Applications from domestic applicants are handled according to the procedures and requirements for new drugs or generic drugs, whereas applications from overseas applicants are handled according to those for imported drugs.

On 29 October 2014, the Chinese Center for Drug Evaluation (CDE), which is part of CFDA, published draft biosimilars guidance.

Overarching guideline
This guideline covers all biosimilar products:

Draft guidancefor research and evaluation techniques for biosimilars
Released for consultation: 29 October 2014
End of consultation: 29 November 2014

Until the finalization of the guidance, biosimilars in China will still have to go through a new drug approval process, as is the case for all biologicals. This means that phase III trials have to be carried out.

Domestic copy biologicals have been on the market in China for 20 years, according to data from the Southern Medicine Economic Research Institute (SMEI) of CFDA. The first recombinant human interferon beta 1 was launched in 1989. Domestic erythropoietins, granulocyte colony-stimulating factors and monoclonal antibodies are also commercialized in China. The country has approved 382 genetically engineered drugs and genetically engineered vaccines, but only 21 products are innovative and the rest are copy biologicals, according to SMEI data [1].

Related article
EU guidelines for biosimilars

1.  GaBI Online - Generics and Biosimilars Initiative. China to release biosimilars guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 21]. Available from: www.gabionline.net/Guidelines/China-to-release-biosimilars-guidelines

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Source: CDE, CFDA

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