China Drug Registration Classification System
[Wednesday , 15th Sep 2021]
China Drug Registration Classification System
L. Xia
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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".

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. Please stay tuned to our updates.

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

Session 4: China Drug Registration Classification System 

Before registering a drug in China, pharmaceutical companies need to know which classification the drug product belongs to. After that, the applicant will be able to prepare documents compliant with specific requirements and submit them according to corresponding procedures.

China initiated a reformed system for drug registration classification with the Administrative Measures for Drug Registration implemented since July, 2020. In the same year, the country's drug regulator National Medical Products Administration (NMPA) issued Chemical Drug Registration Classification and Its Application Dossier Requirements and Biological Product Registration Classification and Its Application Dossier Requirements. The two regulations elaborated on the details of the reformed system.

This session will decode China's current drug registration classification system and analyze how the system impacts drug application.


  1. Drug registration classification system in China (the webinar focusing on the classifications of chemical drugs and biological products).

  2. What information should be included in an application submitted under the corresponding classification?

  3. Comparison with the previous classification system: what have changed & how the changes impact drug application?

  4. Questions & answers.

L. Xia
Master of Pharmaceutical Chemistry and Technology (CTF), University of Milan
Ms. Xia has a deep understanding of the regulations on 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.