Chinese Drug Legislative Framework
[Monday, 31st May 2021]
Chinese Drug Legislative Framework
L. Xia

Understanding China Pharmaceutical Regulations Webinar Series in H1 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 easily accessible for Chinese patients.

Given the growing concern of the Chinese people for health and the huge consumption potential of the Chinese pharmaceutical market, more and more international pharmaceutical companies are targeting this market.

To help relevant industry enterprises and individuals understand the current pharmaceutical regulations and the future trend in China, the BaiPharm team under ChemLinked plans to launch this webinar series in the upcoming months of 2021.

There will be at least 10 topics, covering China's drug regulatory authorities, major laws & regulations, DMF system, MAH rules, drug registration classifications, new drugs, generic drugs, clinical requirements, change management, pharmacovigilance, etc. Topics could be revised or added based on the needs of all members. Welcome to drop your feedback to

Session 2: Chinese Drug Legislative Framework

China joined the ICH (International Council for Harmonisation Technical Requirements for Pharmaceuticals for Human Use) in 2017. Since then, the country has been reforming its pharmaceutical regulatory system, including establishing the MAH (marketing authorization holder) system to implement ICH's standards and guidelines. These changes significantly impact on the domestic and foreign pharmaceutical companies' registration strategy and approach to the NMPA. In the second session of the webinar series, our guest speaker Ms. Xia will introduce China's drug legislative framework and elaborate on specific regulations.

Session 1: Chinese Drug Administration & Regulation System

Session 3: China DMF Filing System for APIs, Pharmaceutical Excipients and Packaging Materials


1.       Overview of China drug legislative framework

2.       General law of drug administration

3.       General regulation of drug registration

4.       Site inspection regulation

5.       The MAH (marketing authorization holder) system

6.       Variation management

7.       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.
If you have any question about this webinar, please contact us:
+86 (0)571 8710 3829