With the revision and promulgation of the Drug Administration Law in 2019, Chinese drug review and approval system has been strengthened and improved. The result of policy reform reflects the perfection and improvement of rules and regulations and technical guiding principles, and this aspect is also embodied in the examination and approval results of varieties declared by enterprises. 

With the ongoing support and attention of the NMPA for innovative drugs, the R&D achievements have been continuously confirmed. According to incomplete statistics, by the end of December 19, 2021, NMPA has approved 75 new drugs (excluding new indications) in 2021, including 39 Chinese new drugs and 36 imported ones. These achievements are obtained with the joint efforts of review agencies, regulatory authorities and industry and enterprises. This paper, efforts are made to summarize and analyze briefly for the reference of industry professionals. 

Part I: Summary of new drug review in 2021 

The following is a summary of the drugs reviewed and approved by NMPA in 2021, which are embodied in different tables according to different approval types. 

Table 1 List of New Drugs Approved by NMPA in 2021 

Table 2 List of Chinese Innovative Drugs Approved in 2021 

Table  3 List of Vaccine Approved in 2021 

Table 4 List of Imported New Drugs Approved in 2021 

Analysis 

As for drug types, the approved drugs in 2021 include 42 chemical drugs, 11 traditional Chinese medicines, 17 biological drugs (including 2 cell therapy products) and 5 vaccines (including 3 COVID-19 vaccines). 

In terms of the analysis of drug formulation, there are 31 injections, accounting for around 41.3% of the total number, and others are oral preparations (including tablets, capsules, oral liquids, etc.). It indicates that the declaration and R&D of sterile innovative drugs still account for a large proportion in China. You could get more information about New Drugs Approved by NMPA in 2021 and other medical and surgical supplies at Pharmasources.com.

From the perspective of therapeutic field, apart from traditional Chinese medicine and vaccine products, among the other 59 products, anti-tumor products account for the largest proportion, up to 33 (including 12 Chinese drugs and 11 imported products). Other products involve drugs for anti-infection, immune system, blood system and some rare diseases, as well as hypoglycemic and lipid-lowering drugs. It reflects that the industry is unwilling to give up on the hot track, even though it is well known that the track is crowded. 

It shall be noted that the number of innovative traditional Chinese medicine approved this year is the largest in recent years, which embodies not only the profoundness of Chinese medicine, but also the achievements of national attention to traditional Chinese medicine. For specific analysis, please refer to 2021 Summary Analysis of New Regulations for Examination and Approval of Traditional Chinese Medicine New Drugs with Approval Quantity Reaching a New High. 

However, we must also be aware that in the secondary market, investors' recognition of the Chinese pharmaceutical innovation field is declining. It remains to be understood whether this embarrassing situation is a temporary market fluctuation or a preliminary indication of long-term investment trends. The practitioners in various sub-sectors in the industry shall attach great importance to it. 

About the Author:

zhulikou431

Zhulikou431, as a senior engineer, PDA member, ISPE member, ECA member, PQRI member, senior aseptic GMP expert, has deep knowledge in aseptic process development and verification, drug development and registration, CTD document writing and review, regulatory audit, international certification, international registration , quality system construction and maintenance, as well as sterile inspection, environmental monitoring and other fields. In recent years, he has focused on the analysis of trends in the macro pharmaceutical field and the risk management of pharmaceutical enterprise mergers and acquisitions projects.