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 1: Chinese Drug Administration & Regulation System
In this first session of the webinar series, our guest speaker Ms. 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
Session 3: China DMF Filing System for APIs, Pharmaceutical Excipients and Packaging Materials