Chinese Drug Administration & Regulation System
Language:
[Wednesday , 26th May 2021]
Chinese Drug Administration & Regulation System
L. Xia
Contact
If you have any question about this webinar, please contact us:
+86 (0)571 8710 3829
contact@chemlinked.com
Background

Understanding China Pharmaceutical Regulations Webinar Series

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 contact@chemlinked.com.

Session 1: Chinese Drug Administration & Regulation System

In this first session of the webinar series, our guest speaker Mrs. Xia will give an overview introduction of the Chinese drug administration and regulation system and explain how it works. Under the current system, the NMPA (National Medical Products Administration) is the state-level drug regulatory authority, formerly known as CFDA (Chinese food and drug Administration). The CFDA was in charge of the regulatory supervision of food, health food, cosmetics, and medical products, while the NMPA focuses on drugs, medical devices and cosmetics. This session will present the main components of the entire system and give a full picture of NMPA's overall mechanism by introducing its subordinate offices’ functions.

Session 2: Chinese Drug Legislative Framework

https://baipharm.chemlinked.com/new-webinar/chinese-drug-legislative-framework

Session 3: Registration of APIs, Pharmaceutical Excipients and Packaging Materials

https://baipharm.chemlinked.com/new-webinar/registration-of-apis-pharmaceutical-excipients-and-packaging-materials-in-china

Contents

1. NMPA: history and evolution

2. The main components and offices of NMPA

3. Responsibilities of each office under NMPA

4. How do these subordinate offices work together

5. Questions & answers

Speakers
L. Xia
RA Manager
Ms. Xia has a deep understanding of the regulation of 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.