Generic Drug Application Procedures in China
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[Wednesday , 20th Apr 2022]
Generic Drug Application Procedures in China
L. Xia
FREE
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Background

China has become the world's second largest pharmaceutical market. For foreign companies trying to enter the Chinese market, BaiPharm has organized a series of webinars to help them understand Chinese pharmaceutical regulations: 

This year, we'll bring more webinars on phamaceutical regulatory compliance in China. Webinar topics are open for discussion by our ChemLinked BaiPharm members. If you have any questions or advice, welcome to send an email to contact@chemlinked.com.

Generic Drug Registration in China

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?

Contents
  1. Generic drug application: procedures, timeline and fees;

  2. Differences between procedures for registering Class 3, Class 4, and Class 5 generics;

  3. Reference Listed Drug (RLD) requirements for generic drugs imported to China;

  4. Case sharing: generic drug registration;

  5. Questions & answers.

Speakers
L. Xia
Master of Pharmaceutical Chemistry and Technology (CTF), University of Milan
Ms. Xia has a deep understanding of the regulations on pharmaceutical products, APIs and excipients in China and Europe. She once worked in Industriale Chimica SRL and Flamma Spa in Italy for years and joined a Chinese pharmaceutical company Zhejiang Hengkang Pharmaceutical Co., Ltd. as RA manager in 2016. With her extensive experience on both RA and QA positions, she is familiar with submitting registration applications for domestic and imported finished drug products, APIs, and pharmaceutical excipients to China NMPA, and CEP applications to EDQM, etc.