BRIEF— Vaccine bioequivalence guidance from China's NMPA

China's National Medical Products Administration (NMPA) has issued a bioequivalence comparison guideline for Chinese generic vaccine manufacturers.

According to the guideline, comparison tests between the generic vaccine and its brand-name version should be run before and during clinical studies.

All the brand-name vaccines for testing must be already available in the China market.

China will also build a vaccine management system to ensure vaccine quality.

The system should include vaccine transportation, storage, tracking and recall.

China recently suffered a series of vaccine quality scandals, and the NMPA expects the guideline, which is not mandatory but an important reference for future policies, will help restore the nation's vaccine industry.