Editor's Notes: Monthly recap is a collection of China's regulations, policies, and standards on medicines, including chemicals and biologics. Generally, they are issued by these authorities:
National Medical Products Administration (NMPA);
Center for Drug Evaluation (CDE), NMPA;
National Health Commission (NHC);
National Healthcare Security Administration (NHSA);
National Joint Drug Procurement Office;
Chinese Pharmacopoeia (ChP) Commission.
The following are the regulatory updates in September 2023.
1. NMPA Publishes the 2022 China Drug Evaluation Report
2. NHC Releases the 2nd Catalog of Rare Diseases
3. NMPA Adjusts Anesthetic and Psychotropic Drug Catalogs
4. CDE Unveils 2022 Report on the Progress of New Drug Clinical Trials in China
5. NMPA Grants Three Rx-to-OTC Switches
6. ICH, NMPA, and CDE Release Pharmaceutical Guidelines
7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
1. NMPA Publishes the 2022 China Drug Evaluation Report
On Sept. 6, China’s NMPA released the 2022 Drug Evaluation Report. According to the report, China approved a total of 21 innovative drugs, including three first-in-class new drugs, and authorized a record high of 66 pediatric drugs last year.
Download the 2022 annual data on China’s drug approvals at BaiPharm Insight.
2. NHC Releases the 2nd Catalog of Rare Diseases
On Sept. 20, China’s NHC and five other authorities collaborated to release the Second Catalog of Rare Diseases, which comprises 86 rare diseases across various medical specialties including hematology, dermatology, rheumatology & immunology, pediatrics, neurology, and endocrinology.
This new catalog supplements the initial announcement made in 2018, expanding the number of recognized rare diseases in China to 207. Find the full catalog at BaiPharm News.
3. NMPA Adjusts Anesthetic and Psychotropic Drug Catalogs
On Sept. 11, China’s NMPA, Ministry of Public Security, and NHC announced the adjustments to the Catalogs of Anesthetics and Psychotropic Drugs. The changes are as follows:
Tegileridine is included in the Catalog of Anesthetics.
Dimdazenil and etomidate (excluding pharmaceutical preparations containing etomidate that have been authorized for marketing in China) are included in the Catalog of Category II Psychotropic Drugs.
Modafinil, previously categorized as a category I psychotropic drug, is recategorized as a category II psychotropic drug.
The adjustments took effect on Oct. 1, 2023.
Find out more about how China regulates anesthetics and psychotropics.
4. CDE Unveils 2022 Report on the Progress of New Drug Clinical Trials in China
On Sept. 7, CDE rolled out the 2022 Report on the Progress of New Drug Clinical Trials in China. According to the report, a remarkable total of 3,410 clinical trials were registered on CDE's clinical trial registration and publication platform in 2022, setting a new record. Among these trials, 1,974 were related to new drugs, representing a slight decrease from the 2,033 clinical trials conducted in 2021.
Chemical drugs accounted for 50% of the registered clinical trials, while biologics constituted 40%. Notably, there were 46 clinical trials focusing on cell and gene therapies, including 12 trials specifically dedicated to mesenchymal stem cell therapies.
5. NMPA Grants Three Rx-to-OTC Switches
On Sept. 13, China NMPA announced three formerly prescription drugs had been granted OTC status. The three drugs are all Chinese patent medicines and include:
Bupleurum Falcatum Granules (Xiaochaihu Keli);
Rhodiola cretinii subsp. Sinoalpina Oral Solution (Gaoshan Hongjingtian Koufuye);
Zhongsheng Tablets (Zhongsheng Pian).
View the full OTC drug catalog at BaiPharm Database.
6. ICH, NMPA, and CDE Release Pharmaceutical Guidelines
In September 2023, China drug regulators issued the following guidelines:
7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
In September 2023, the Chinese Pharmacopoeia Commission released the following draft standards.
No. | Draft standard | Type | Consultation |
1 | Monograph on TCM | 05/09/2023-05/12/2023 | |
2 | General chapter | 07/09/2023-08/10/2023 | |
3 | General chapter | 07/09/2023-08/10/2023 | |
4 | General chapter | 07/09/2023-08/10/2023 | |
5 | General chapter | 07/09/2023-08/10/2023 | |
6 | General chapter | 07/09/2023-07/12/2023 | |
7 | General chapter | 07/09/2023-07/12/2023 | |
8 | General chapter | 07/09/2023-08/10/2023 | |
9 | General chapter | 07/09/2023-08/10/2023 | |
10 | Monograph on TCM | 07/09/2023-07/12/2023 | |
11 | Monograph on TCM | 07/09/2023-07/12/2023 | |
12 | Monograph on excipient | 08/09/2023-08/12/2023 | |
13 | General chapter | 13/09/2023-13/12/2023 | |
14 | 1105 Microbiological Examination of Nonsterile Products, Microbial Enumeration Tests | General chapter | 13/09/2023-13/12/2023 |
15 | 1106 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms | General chapter | 13/09/2023-13/12/2023 |
16 | 1107 Microbiological Acceptance Criteria of Nonsterile Pharmaceutical Product | General chapter | 13/09/2023-13/12/2023 |
17 | General chapter | 13/09/2023-13/12/2023 | |
18 | Monograph on API | 13/09/2023-13/12/2023 | |
19 | General chapter | 14/09/2023-15/10/2023 | |
20 | General chapter | 14/09/2023-15/10/2023 | |
21 | General chapter | 14/09/2023-15/10/2023 | |
22 | General chapter | 14/09/2023-14/12/2023 | |
23 | General chapter | 14/09/2023-14/12/2023 | |
24 | General chapter | 14/09/2023-14/12/2023 | |
25 | General chapter | 14/09/2023-14/12/2023 | |
26 | General chapter | 14/09/2023-14/12/2023 | |
27 | General chapter | 14/09/2023-14/12/2023 | |
28 | General chapter | 14/09/2023-14/12/2023 | |
29 | General chapter | 14/09/2023-14/12/2023 | |
30 | General chapter | 14/09/2023-15/10/2023 | |
31 | 5300 Plastic Containers and Components for Pharmaceutical Packaging 5301 Plastic Containers and Components for Solution for Injection 5302 Plastic Bottles and Components for Eye Drops 5303 Plastic Bottles and Components for Topical Solution 5304 Composite Tubes and Components for Topical Ointment 5305 Plastic Bottles and Components for Oral Solution 5306 Plastic Bottles and Components for Oral Solid Dosage Forms 5307 Composite Films and Packages for Oral Solid Dosage Forms 5308 Hard Plates for Oral Solid Dosage Forms | General Chapter | 14/09/2023-14/12/2023 |
32 | Monograph on excipient | 14/09/2023-14/12/2023 | |
33 | 0982 Determination of Particle Size and Particle Size Distribution | General chapter | 25/09/2023-25/12/2023 |
34 | Monograph on TCM | 25/09/2023-25/12/2023 | |
35 | Monograph on TCM | 25/09/2023-25/12/2023 | |
36 | Monograph on TCM | 25/09/2023-25/12/2023 | |
37 | Monograph on excipient | 27/09/2023-27/12/2023 | |
38 | Monograph on excipient | 27/09/2023-27/12/2023 |
Contact BaiPharm if you’d like to know more about drug regulations in China.
