Generic Drug Application Procedures in China

Time: 3:00pm ~ 4:00pm, 22 June 2022 (UTC+8 China Time)

Language: English

Organizer: CPhI & P-MEC China

Co-organizer: BaiPharm

Agenda

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 definitions and registration classifications of generics in China?

·         How the RLD is regulated and how the RLD choice affect the ANDA pathway?

·         What is the main requirement of Quality and Therapeutic Equivalence in China?

·         Will overseas clinical/bioequivalence (BE) data be accepted by China CDE?

·         What is the key point in China to prepare ANDA dossier?

·         The timeline and registration fee for ANDA.

Speakers

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