Background
China has become a powerhouse that manufactures and imports generic drugs. These years, the country’s Center for Drug Evaluation (CDE) has approved substantial abbreviated new drug applications (ANDA) for generics. In 2020, CDE completed reviewing 1,700 ANDAs, accounting for 19.75% of all the 8,606 applications that entailed technical review. In China, the competition is spiraling up for generics as the drug regulators mandate consistency evaluation for generic products and slash prices through negotiation for volume-based procurement (VBP). Nevertheless, the Chinese market still has huge potential for generic drug products, especially for generics that overcome technical barriers.
In this webinar, we will introduce how to apply for generic drug registration in China and answer the following questions:
- What are the corresponding requirements for registering generics under each different classification?
- What are the specific requirements in China for Chemistry, Manufacturing and Controls (CMC) changes to approved ANDAs？
- Will overseas clinical/bioequivalence (BE) data be accepted by China CDE?
