Understanding China Pharmaceutical Regulations Webinar Series in H2 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 accessible to Chinese patients.
Given the growing concern of the Chinese people for health and the huge potential of the Chinese market, more and more international pharmaceutical companies are trying to enter the market or claim a bigger share.
To help enterprises and individuals understand the current drug regulations and the industry trend in China, our ChemLinked BaiPharm Team launched a webinar series on China drug regulations.
In May and June this year, we organized three webinars "Chinese Drug Administration & Regulation System", "Chinese Drug Legislative Framework", and "DMF Filing for APIs, Pharmaceutical Excipients and Packaging Materials in China" (Know more at baipharm.chemlinked.com/webinar).
In the second half of 2021, we will hold webinars focusing on drug registration. We'll also introduce China's Marketing Authorization Holders (MAH) rules and drug licensing in/out deals. Stay tuned and we'll update the webinars' specific contents.
Webinar topics could be revised or added based on the needs of our ChemLinked BaiPharm members. If you have any questions or advice, welcome to send an email to firstname.lastname@example.org.
Session 6: New Chemical Drug Application Procedures in China
Since the reform of the drug review and approval system in 2017, China drug regulators have been stepping up incentives for developing innovator drugs. The regulators offer policy support in terms of review and approval to encourage the innovator drug products in urgent clinical needs or with distinct clinical value.
This webinar session will introduce basic concepts of new chemical drug application (NDA) in China, the application procedures, and the clinical data requirements. The session will also analyze the chances and challenges for NMPA-EMA and NMPA-FDA drug applications as there is an increasing number of simultaneous submissions to regulators in different regions.
NMPA: China National Medical Products Administration
EMA: European Medicines Agency
FDA: US Food & Drug Administration