Registration of APIs, Pharmaceutical Excipients and Packaging Materials in China
Language:
[Tuesday , 22nd Jun 2021]
Registration of APIs, Pharmaceutical Excipients and Packaging Materials in China
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 3: Registration of APIs, Pharmaceutical Excipients and Packaging Materials in China

In 2017, NMPA announced the new review and approval regulations for APIs, pharmaceutical excipients and packaging materials (AEPs) in China. The regulations changed AEPs' registration pathway, consequently impacting the FDF (Finished Dosage Form) registration approach. The current AEP management system in China is like a combination of US DMF system and EU CEP system; however, the registration scope, and active status management and technical requirements are still different. In this webinar, our guest speaker Mrs. Xia will interpret how to register APIs, pharmaceutical excipients and packaging materials in China.

Session 1: China Drug Administration & Regulation System 

https://baipharm.chemlinked.com/new-webinar/chinese-drug-administration-regulation-system

Session 2: Chinese Drug Legislative Framework

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

Contents

1.       Introduction of the API, excipient & packaging material (AEP) registration system: its chronology and current regulations in China

2.       Summary of the new DMF filing requirements for AEPs in China

3.       The DMF filing, review & approval process of AEPs in China

4.       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.