BRIEF—China instigates bio-equivalence testing for generic injectables

China on May 12 initiated bio-equivalence testing for generic injectables, including those are already in the market as well as those that have not filed a New Drug Application (NDA) according to the National Medical Products Administration (NMPA).

Like the testing for generic non-injectables, injectables also have to be tested against their branded versions.

The injectables with proven clinical value whose branded counterparts are no longer available are allowed to skip the testing.

These injectables include glucose and saline injection.

The market size of generic injectables in China was about 626.4 million renminbi ($88.2 million) as of 2018, according to NMPA.