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China introduces new quality and efficacy requirements for generics Posted 06/05/2016

The Chinese Food and Drug Administration (CFDA) has announced that generics in China must show bioequivalence to the originator reference product and has prohibited the use of locally made generics as reference products.

In 2013, CFDA issued guidelines that required generics to achieve bioequivalence to brand-name drugs in a drive to improve China’s pharmaceutical industry. The guidelines identified 75 different types of generics requiring testing.

Then in 2016, CFDA mandated that pharmaceutical companies must ensure that the quality and efficacy of their generics are on a par with brand-name drugs through in-house assessments. The move comes as part of an effort to improve the nation’s pharmaceutical industry.

Generics comprise 80% of the total drug market in China, which is the second largest market in the world after the US [1]. The government has made it clear that locally made generics cannot be used as a reference drug in the evaluation process, a point of contention with local pharmaceutical manufactures.

In March 2016, CFDA circulated a guidance document entitled Opinion of Generics Quality and Efficacy Evaluation outlining in detail the evaluation methods to be used. The guidance also provides a clearer definition of ‘reference drug’. The review and approval of generics will now take the brand-name (originator) drug as the reference to ensure that the quality and efficacy of the generic drug is consistent with that of the originator drug.

For generics that have been approved for marketing in China prior to the reform, the requirement for the consistency evaluation will be rolled out in phases. Generics approved before 1 October 2007 are required to be tested by the end of 2018. The deadline for generics undergoing clinical trials is the end of 2021.

In vitro dissolution testing still remains the primary testing method, however, in vivo testing has also been introduced and a list of which drugs should be tested in this way will be released.

The names of generics manufacturers whose drugs pass the comparison test will be listed on the CFDA website and the credit can be included on the drug label for marketing purposes.

The guidance document also states that generics that pass the bioequivalence tests will be prioritized by reimbursement policies and as preferred drugs for public hospitals.

Local drug firms have, however, resisted past efforts to use brand-name products as the reference in quality control. A crackdown on quality that began in 2015 has already seen a number of pharmaceutical companies withdraw generic drug candidates for approval.

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1. GaBI Online - Generics and Biosimilars Initiative. China’s healthcare reform in 2010 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Policies-Legislation/China-s-healthcare-reform-in-2010

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Source: SFDA

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