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 email@example.com.
Session 3: China DMF Filing System for APIs, Pharmaceutical Excipients and Packaging Materials
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 to filing, 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 Ms. Xia will interpret how to register APIs, pharmaceutical excipients and packaging materials in China.
Besides watching the webinar video or downloading the slides, you can also read our article "China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients and Packaging Materials".