Editor's Notes: Monthly recap is a collection of China's recent pharmaceutical laws, regulations, policies, and standards mainly issued by the following authorities:
National Medical Products Administration (NMPA);
NMPA's Center for Drug Evaluation (CDE);
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 Jan. 2023:
1. China Issues the 2022 National Reimbursement Drug List
2. China Approves Two Homegrown Drugs for COVID-19
3. China Releases Two Lists of RLDs
4. China Issues GLP Certification Regulation
5. China Rolls Out Pharmaceutical Guidelines
6. Chinese Pharmacopoeia Commission Issues Drafts of Standards
1. China Issues the 2022 National Reimbursement Drug List
On Jan. 18, China’s National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security issued the 2022 National Reimbursement Drug List (NRDL), a list of drugs fully or partially reimbursed by China’s national basic health insurance.
111 drugs entered the 2022 NRDL after bidding or price negotiation between NHSA and pharmaceutical companies. The average price cut reached 60.1%.1
The adjusted NRDL covers 2,967 drugs, including 1,586 western (chemical/biological) drugs and 1,381 Chinese patent medicines. Learn more at BaiPharm News.
2. China Approves Two Homegrown Drugs for COVID-19
On Jan. 28, China NMPA conditionally approved two drugs for COVID-19.
1) Simcere Pharmaceutical Group’s Simnotrelvir Tablets / Ritonavir Tablets (XIAN NUO XIN);
2) Shanghai Vinnerna Biosciences (joint venture of Shanghai Junshi Biosciences and Suzhou Wangshan Wangshui Biomedicine)' Deuremidevir Hydrobromide Tablets (MIN DE WEI).
Both are approved for treating adult patients with mild-to-moderate COVID-19 infection.2
So far, six drugs have acquired marketing authorization in China for COVID-19 treatment. Read more at BaiPharm News.
3. China Releases Two Lists of RLDs
In Jan. 2023, China NMPA released the 63rd3 and the 64th4 lists of reference listed drugs (RLDs), including Eli Lilly’s Verzenios and Chiesi Farmaceutici’s Curosurf. China’s RLD Catalog now covers 5,619 drugs. View the full data at BaiPharm Database.
4. China Issues GLP Certification Regulation
After consulting on the draft in Oct. 2022, China NMPA issued the Administrative Measures for Good Laboratory Practice (GLP) Certification on Jan. 19. The regulation will take effect on July 1, 2023, stipulating that GLP certification is mandatory for institutions that conduct non-clinical safety evaluation studies for drug registration applications in China.5
5. China Rolls Out Pharmaceutical Guidelines
In Jan. 2023, China NMPA and its affiliated office CDE published a series of guidelines and adopted some guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
No. | Guidelines | Authority | Status | Issuance | Enforce-ment |
1 | ICH & NMPA | In force | 29/01/2023 | 29/01/2023 | |
2 | ICH & NMPA | In force | 29/01/2023 | 29/012023 | |
3 | R&D Guidelines on the Oral Combination Drugs for Type 2 Diabetes Mellitus | CDE | Draft | 03/01/2023 | / |
4 | CDE | Draft | 06/01/2023 | / | |
5 | ICH & CDE | Draft | 06/01/2023 | / | |
6 | Technical R&D Guidelines on Improved Traditional Chinese Medicines | CDE | Draft | 06/01/2023 | / |
7 | Clinical R&D Guidelines on New Drugs for Chronic Lymphocytic Leukemia | CDE | Draft | 19/01/2023 | Jan. 19, 2023 |
8 | Guidance for Electronic Common Technical Document (eCTD) Implementation V1.1 | CDE | Draft | 29/01/2023 | / |
9 | CDE | Draft | 29/01/2023 | / |
6. Chinese Pharmacopoeia Commission Issues Drafts of Standards
In January 2023, Chinese Pharmacopoeia Commission released the following drafts of drug standards for public comments.
No. | Draft of Standards | Type | Issuance |
1 | 4040 Testing Method for Luer Cone Slip Connector of Prefilled Syringes | Testing Method | Jan. 4, 2023 |
2 | 4041 Testing Method for Sealing Property of Caps and Guards of Prefilled Syringe | Testing Method | Jan. 4, 2023 |
3 | 4042 Testing Method for Pull-off Force of Caps of Prefilled Syringes | Testing Method | Jan. 4, 2023 |
4 | 4043 Testing Method for Tightness of Caps and Guards of Prefilled Syringe | Testing Method | Jan. 4, 2023 |
5 | Determination Method | Jan. 4, 2023 | |
6 | 4045 Determination Method for the Torsion Resistance of Adapter Collars of Prefilled Syringes | Determination Method | Jan. 4, 2023 |
7 | 4046 Determination Method for the Pull-off Force of Adapter Collars of Prefilled Syringes | Determination Method | Jan. 4, 2023 |
8 | 4226 Determination Method for Tungsten Dissolution Amount in Prefilled Syringes | Determination Method | Jan. 4, 2023 |
9 | 4227 Determination Method for Silicone Oil in Prefilled Syringes | Determination Method | Jan. 4, 2023 |
10 | 4206 Determination Method for Insoluble Particles in Pharmaceutical Packaging Materials | Determination Method | Jan. 4, 2023 |
11 | General Chapter | Jan. 4, 2023 | |
12 | General Chapter | Jan. 4, 2023 | |
13 | 4209 Determination of Ethylene Oxide in Pharmaceutical Packaging Materials | General Chapter | Jan. 11, 2023 |
14 | Determination Method | Jan. 11, 2023 | |
15 | Guidelines on Determination of Critical Micelle Concentration | Guideline | Jan. 16, 2023 |
16 | 5300 Plastic Containers and Components for Pharmaceutical Packaging | General Chapter | Jan. 16, 2023 |
17 | General Chapter | Jan. 16, 2023 | |
18 | 5303 Plastic Containers and Components for Liquid for External Use | General Chapter | Jan. 16, 2023 |
19 | General Chapter | Jan. 16, 2023 | |
20 | 5306 Plastic Containers and Components for Oral Solid Dosage Forms | General Chapter | Jan. 16, 2023 |
21 | Determination Method | Jan. 16, 2023 | |
22 | 4028 Determination Method for Optical Transmittance of Plastics | Determination Method | Jan. 16, 2023 |
23 | Testing Method | Jan. 16, 2023 | |
24 | Testing Method | Jan. 16, 2023 | |
25 | Determination Method | Jan. 16, 2023 | |
26 | 4212 Determination Method for Ethanol Permeation Through Plastics | Determination Method | Jan. 16, 2023 |
27 | 4213 Determination Method for Oil Permeation Through Plastics | Testing Method | Jan. 16, 2023 |
28 | Determination Method | Jan. 16, 2023 | |
29 | Determination Method | Jan. 16, 2023 | |
30 | Pharmaceutical Excipient Standard | Jan. 16, 2023 | |
31 | Testing Method | Jan. 31, 2023 | |
32 | Testing Method | Jan. 31, 2023 | |
33 | Testing Method | Jan. 31, 2023 | |
34 | Testing Method | Jan. 31, 2023 | |
35 | Bioassay Method | Jan. 31, 2023 | |
36 | Assay Method | Jan. 31, 2023 | |
37 | Pharmaceutical Excipient Standard | Jan. 31, 2023 | |
38 | Pharmaceutical Excipient Standard | Jan. 31, 2023 | |
39 | Pharmaceutical Excipient Standard | Jan. 31, 2023 | |
40 | Partially Neutralized Methacrylic Acid and Ethyl Acrylate Copolymer | Pharmaceutical Excipient Standard | Jan. 31, 2023 |
41 | Pharmaceutical Excipient Standard | Jan. 31, 2023 | |
42 | Pharmaceutical Excipient Standard | Jan. 31, 2023 |
Contact BaiPharm if you need more details of the summarized contents above.