New Chemical Drug Application Procedures in China
New Chemical 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 6: New Chemical Drug Application Procedures in China

Since the reform of the drug review and approval system in 2017, China drug regulators have been stepping up incentives for developing innovator drugs. The regulators offer policy support in terms of review and approval to encourage the innovator drug products in urgent clinical needs or with distinct clinical value.

This webinar session will introduce basic concepts of new chemical drug application (NDA) in China, the application procedures, and the clinical data requirements. The session will also analyze the chances and challenges for NMPA-EMA and NMPA-FDA drug applications as there is an increasing number of simultaneous submissions to regulators in different regions.


  • NMPA: China National Medical Products Administration

  • EMA: European Medicines Agency

  • FDA: US Food & Drug Administration

Session 4: China Drug Registration Classification System

Session 5: Generic Drug Application Procedures in China

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


1. Definition of new chemical drug registration application in China;

2. New chemical drug application in China: procedures, timeline and fees;

3. Clinical trial requirements: acceptance of data from overseas/multi-regional clinical trials;

4. Case sharing: opportunities and challenges for simultaneous NMPA-EMA or NMPA-FDA submissions;

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.