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CDE data shows that since January 1, 2022, CDE has accepted a total of 3,355 drug registration applications (calculated by acceptance number, data statistics are as of April 14, 2022, the same below)
.
According to the statistics of drug types, 2391 chemical drugs, 428 traditional Chinese medicines, 533 biological products and 1 in vitro preparation were accepted
.
The following is the author's incomplete statistical analysis based on the acceptance of various drugs.
If there is any omission, please correct me
.
Data source: CDE, compiled by PharmaNet (Note: based on the acceptance number, the statistical time is from January 1, 2022 to April 14, 2022) Specifically, in chemical drug registration applications, compared with 2021, this year's 2,391 chemical drugs have been accepted, accounting for about 63% of the 3,800 acceptance numbers from January to June 2021
.
The application types for chemical drugs this year are mainly supplementary applications, with a total of 1165 acceptance numbers
.
Followed by imitation & existing national standards, reaching 633, 265 new drugs, 158 imported, and 97 imported and re-registered
.
Data source: CDE, collated by PharmaNet (Note: It is calculated based on the acceptance number, and the statistical time is from January 1, 2022 to April 14, 2022) As of April 14, 2022, 428 Chinese medicine registration applications have been accepted.
In terms of type, supplementary applications also account for half of the acceptance of traditional Chinese medicine, with a total of 404 applications accepted
.
In addition, there are 20 new drugs, 1 imitation & existing national standard, and 1 imported and re-registered
.
Data source: CDE, collated by PharmaNet (Note: based on the acceptance number, the statistical time is from January 1, 2022 to April 14, 2022) It is worth mentioning that compared with 2021, the registration application of traditional Chinese medicine has The number of accepted applications has exceeded the cumulative 401 TCM registration applications accepted by CDE from January to June 2021
.
The analysis believes that the reason behind it is expected to be closely related to the standardization of drug review materials and the rapid improvement of the efficiency of the review center
.
In recent years, favorable policies have continued to increase, boosting the rapid development of traditional Chinese medicine
.
In particular, the approval and review of new Chinese medicines has been significantly accelerated, which has greatly shortened the time for Chinese medicines to be marketed.
In 2021, a total of 12 new Chinese medicines have been approved for marketing, setting a new high in the number of years
.
Entering 2022, good news about the accelerated launch of new Chinese medicines has come one after another
.
Among them, the review period of icariin soft capsules, an innovative traditional Chinese medicine that passed the review and market in early 2022, was only 267 days, which was 92% shorter than that in 2017
.
A total of 533 applications for drug registration of biological products have been accepted, which is a significant increase compared with the 382 applications for registration of biological products accepted by CDE from January to June 2021
.
Among them, the number of supplementary application acceptance numbers reached 240, followed by 201 new drugs, 14 re-registration for import, and 60 for import
.
Data source: CDE, collated by PharmaNet (Note: based on the acceptance number, the statistical time is from January 1, 2022 to April 14, 2022) In addition, the in vitro preparations are only hepatitis B virus and hepatitis C of Wantai Bio Viruses and Human Immunodeficiency Virus (Type 1+2) nucleic acid detection kits (PCR-fluorescence method) are listed in the catalogue of varieties accepted by CDE, and the application type is supplementary application
.
Conclusion On the whole, the acceptance of drug registration applications in China since 2022 is remarkable, especially the situation of new drug applications of traditional Chinese medicines, which is worthy of attention
.
In the first quarter, CDE has accepted a total of 18 new Chinese medicine registration applications, which is more than the same period last year, and the types of new Chinese medicines applied for are focused on categories 1.
1 and 1.
2.
Some Chinese medicine companies are on the road to new drug research and development.
5 new Chinese medicine registration applications were accepted
.
The industry believes that with the support of a series of favorable policies, it is expected that new Chinese medicine drugs will usher in a big outbreak in the future
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to the statistics of drug types, 2391 chemical drugs, 428 traditional Chinese medicines, 533 biological products and 1 in vitro preparation were accepted
.
The following is the author's incomplete statistical analysis based on the acceptance of various drugs.
If there is any omission, please correct me
.
Data source: CDE, compiled by PharmaNet (Note: based on the acceptance number, the statistical time is from January 1, 2022 to April 14, 2022) Specifically, in chemical drug registration applications, compared with 2021, this year's 2,391 chemical drugs have been accepted, accounting for about 63% of the 3,800 acceptance numbers from January to June 2021
.
The application types for chemical drugs this year are mainly supplementary applications, with a total of 1165 acceptance numbers
.
Followed by imitation & existing national standards, reaching 633, 265 new drugs, 158 imported, and 97 imported and re-registered
.
Data source: CDE, collated by PharmaNet (Note: It is calculated based on the acceptance number, and the statistical time is from January 1, 2022 to April 14, 2022) As of April 14, 2022, 428 Chinese medicine registration applications have been accepted.
In terms of type, supplementary applications also account for half of the acceptance of traditional Chinese medicine, with a total of 404 applications accepted
.
In addition, there are 20 new drugs, 1 imitation & existing national standard, and 1 imported and re-registered
.
Data source: CDE, collated by PharmaNet (Note: based on the acceptance number, the statistical time is from January 1, 2022 to April 14, 2022) It is worth mentioning that compared with 2021, the registration application of traditional Chinese medicine has The number of accepted applications has exceeded the cumulative 401 TCM registration applications accepted by CDE from January to June 2021
.
The analysis believes that the reason behind it is expected to be closely related to the standardization of drug review materials and the rapid improvement of the efficiency of the review center
.
In recent years, favorable policies have continued to increase, boosting the rapid development of traditional Chinese medicine
.
In particular, the approval and review of new Chinese medicines has been significantly accelerated, which has greatly shortened the time for Chinese medicines to be marketed.
In 2021, a total of 12 new Chinese medicines have been approved for marketing, setting a new high in the number of years
.
Entering 2022, good news about the accelerated launch of new Chinese medicines has come one after another
.
Among them, the review period of icariin soft capsules, an innovative traditional Chinese medicine that passed the review and market in early 2022, was only 267 days, which was 92% shorter than that in 2017
.
A total of 533 applications for drug registration of biological products have been accepted, which is a significant increase compared with the 382 applications for registration of biological products accepted by CDE from January to June 2021
.
Among them, the number of supplementary application acceptance numbers reached 240, followed by 201 new drugs, 14 re-registration for import, and 60 for import
.
Data source: CDE, collated by PharmaNet (Note: based on the acceptance number, the statistical time is from January 1, 2022 to April 14, 2022) In addition, the in vitro preparations are only hepatitis B virus and hepatitis C of Wantai Bio Viruses and Human Immunodeficiency Virus (Type 1+2) nucleic acid detection kits (PCR-fluorescence method) are listed in the catalogue of varieties accepted by CDE, and the application type is supplementary application
.
Conclusion On the whole, the acceptance of drug registration applications in China since 2022 is remarkable, especially the situation of new drug applications of traditional Chinese medicines, which is worthy of attention
.
In the first quarter, CDE has accepted a total of 18 new Chinese medicine registration applications, which is more than the same period last year, and the types of new Chinese medicines applied for are focused on categories 1.
1 and 1.
2.
Some Chinese medicine companies are on the road to new drug research and development.
5 new Chinese medicine registration applications were accepted
.
The industry believes that with the support of a series of favorable policies, it is expected that new Chinese medicine drugs will usher in a big outbreak in the future
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
