Decoding China's MAH System
Decoding China's MAH System
L. Xia
If you have any question about this webinar, please contact us:
+86 (0)571 8710 3829

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 7: Decoding China's MAH System

 As the amended Drug Administration Law took effect in Dec. 2019, the drug Marketing Authorization Holder (MAH) system required by the law has become part of China's drug regulation framework.

According to the law, an MAH shall be responsible for safety, efficacy and quality control of the drugs in the process of development, manufacture, supply and usage.

For international pharmaceutical companies, understanding China's MAH system can help them assess risks and ensure their products are compliant with Chinese regulations.

This webinar will specify the qualifying criteria for MAHs in China, and addresses the MAH-related issues significant to overseas pharma companies:

  • Differences between an MAH and a local agent in China;

  • How to transfer the product ownership to another MAH in China;

  • Case sharing: how to choose an MAH for drugs imported to China.

Session 4: China Drug Registration Classification System

Session 5: Generic Drug Application Procedures in China

Session 6: New Chemical Drug Application Procedures in China


1. Introducing MAH of APIs and FDFs in China

2. The different roles of MAH and local agent in China;

3. How to change the MAH of a drug product: procedures, timeline and fees;

4. For drugs imported to China: how to choose an MAH;

5.  Case analysis;

6. Questions & answers.


  • API: active pharmaceutical ingredient/drug substance;

  • FDF: finished dosage form/finished drug product.

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.