China modifies bioequivalence testing rules and sets new deadlines

By Wang Fangqing

- Last updated on GMT


Related tags Generics Pharmacology

Generic drugs in China must demonstrate bioequivalence (BE) to branded medicines under new CFDA rules prohibiting the use of locally-made generics as reference products.

In 2013 the Chinese Food and Drug Administration (CFDA) issued guidance for BE comparison and even picked 75 types of generics for which testing would be required.

So far little has been achieved, mainly because of the disputes from Chinese pharmaceutical companies over the evaluation methods and the definition of 'reference drug'.

This month​ the agency attempted to clarify the term in a guidance document called “Opinion of generics quality and efficacy evaluation."

According to the document, a reference product must be the brand name version of the generic drug or an imported, globally recognized generic version if the original branded drug is no longer available.

Previously, China had allowed locally made generics to be used as reference products.

According to the opinion, generics approved before October 1, 2007 are all required to be tested by the end of 2018.

For the drugs that have to go through clinical trials for the evaluation, the deadline is the end of 2021. Drugs that fail or skip the test will no longer be registered in China.

Testing methods

The rules on testing have also been modified.

Previously, China evaluated generics based on in vitro dissolution profiles only. However, pharma companies argued that the method is only useful for determining the equivalence of drugs with high permeability and low solubility.

While in vitro dissolution testing remains a primary testing method in the new guidance document, the CFDA has also announced plans to issue a list of drugs that should be evaluated using in vivo BE testing.


To reward the drug makers that produce generics which pass the comparison tests, the CFDA will publish the name of these drugs on its website. Manufacturers are also allowed to add the credit on the drug label for marketing purposes.

More importantly, the new opinion demands the drug which pass the BE tests are favoured by reimbursement policies. The rules also require public hospitals to prioritize these drugs in their procurement plans.

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