Generic Drug Application Procedures in China
Generic Drug Application Procedures in China
L. Xia
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Understanding China Pharmaceutical Regulations Webinar Series in H2 2021

China's pharmaceutical industry is experiencing rapid development these years. The growth can't be achieved without the incentive policies introduced by the Chinese government. The government has been working to improve the pharmaceutical regulatory environment and ensure that medicines are accessible to Chinese patients.

Given the growing concern of the Chinese people for health and the huge potential of the Chinese market, more and more international pharmaceutical companies are trying to enter the market or claim a bigger share.

To help enterprises and individuals understand the current drug regulations and the industry trend in China, our ChemLinked BaiPharm Team launched a webinar series on China drug regulations.

In May and June this year, we organized three webinars "Chinese Drug Administration & Regulation System", "Chinese Drug Legislative Framework", and "DMF Filing for APIs, Pharmaceutical Excipients and Packaging Materials in China" (Know more at

In the second half of 2021, we will hold webinars focusing on drug registration. We'll also introduce China's Marketing Authorization Holders (MAH) rules and drug licensing in/out deals. Stay tuned and we'll update the webinars' specific contents.

Webinar topics could be revised or added based on the needs of our ChemLinked BaiPharm members. If you have any questions or advice, welcome to send an email to

Session 5: Generic Drug Application Procedures 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 centralized procurement. Nevertheless, the Chinese market still has huge potential for generic drug products, especially for generics that overcome technical barriers.

In this session, we will introduce basic concepts in generic drug registration and the application procedures in China. We’ll 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?

Session 4: China Drug Registration Classification System

Session 6: New Chemical Drug Application Procedures in China (in Oct. 2021)

Session 7: Decoding China's MAH System (in Nov. 2021)


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

2. Differences of 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.

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.