Editor's Notes: Monthly recap is a collection of China's laws, 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 December 2023.
1. China Encourages the Development of 39 Generic Drugs
2. China CDE Updates eCTD Structure for Drug Registration Applications
3. China Releases the 74th List of Reference Drugs
4. China Grants One Rx-to-OTC Switch
5. China Consults on Matters Related to Drug Supply and Use
6. China Seeks Public Comments on GMP Addendum on Blood Products
7. China Releases Pharmaceutical Guidelines
8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
1. China Encourages the Development of 39 Generic Drugs
On December 25, 2023, China’s National Health Commission (NHC) and four other authorities jointly issued the third list of encouraged generic drugs. The list comprises 39 drugs based on their active ingredients, encompassing a total of 75 different strengths.
The authorities are encouraging the industry to develop the listed drugs, including facilitating clinical trials, prioritizing their review and approval process, as well as supporting research on critical generic technologies.
2. China Updates eCTD Structure for Drug Registration Applications
On December 11, 2023, China’s Center for Drug Evaluation (CDE) announced important updates regarding the electronic submission of drug registration applications. These updates are compiled into the Technical Requirements for Compact Disks Containing Application Dossiers and Electronic Common Technical Document (eCTD) Structure. In addition, CDE has also introduced the eCTD Validation Criteria as a regulatory document. These three documents will come into effect on March 1, 2024. More details at BaiPharm News.
3. China Releases the 74th List of Reference Drugs
On December 15, 2023, China's NMPA unveiled the 74th list of reference listed drugs (RLDs), comprising a total of 32 products. For the complete RLD list, please refer to BaiPharm Database.
4. China Grants One Rx-to-OTC Switch
On December 15, 2023, China NMPA announced the approval of the over-the-counter (OTC) status for Gujing Yangyuan Mixture, which was previously available only by prescription. To access the full list of OTC drugs, please visit the BaiPharm Database.
5. China Consults on Matters Related to Drug Supply and Use
On December 22, 2023, China’s NMPA released the draft of Matters Related to the Implementation of Administrative Measures for Supervising the Quality of Drug Supply and Use. The draft requires that marketing authorization holders or suppliers who outsource the storage and transportation of drugs must enter into an entrustment quality agreement to clarify each other’s responsibilities. Additionally, regular quality audits should be conducted on the outsourced party.
Related: China's Regulations on Drug Supply Come into Effect
6. China Seeks Public Comments on GMP Addendum on Blood Products
On December 26, 2023, China’s NMPA published the revised draft of Blood Product Addendum to the Good Manufacturing Practices for Drugs. The draft focuses on human plasma protein products as the specific category of blood products. This addendum applies to the manufacturing management, quality control, storage, distribution, transportation, and processing of human blood products. Notably, it prohibits the sharing of facilities, equipment, and devices between blood products and other medicines.
7. China Releases Pharmaceutical Guidelines
In December 2023, China started to enforce five guidelines and issued four guideline drafts.
No | Guidelines | Authority | Status | Issued | Enforced |
1 | Technical Guidelines on Clinical Trials of Therapeutic Drugs for Atopic Dermatitis | CDE | In force | 01/12/2023 | 01/12/2023 |
2 | CDE | In force | 01/12/2023 | 01/12/2023 | |
3 | Technical Guidelines on Clinical Safety Evaluation of New Drugs | CDE | In force | 01/12/2023 | 01/12/2023 |
4 | ICH Q13 Guideline: Continuous Manufacturing of Drug Substances and Drug Products | ICH & NMPA | In force | 14/12/2023 | 14/12/2023 |
5 | Technical Guidelines on Clinically Related Communication of Cell and Gene Therapy Products | CDE | In force | 29/12/2023 | 29/12/2023 |
6 | Technical Guidelines on Clinical Trials of Therapeutic Drugs for Chronic Hepatitis D Virus Infection | CDE | Draft | 01/12/2023 | / |
7 | Technical Guidelines on Clinical Trials of Meningococcal Vaccines | CDE | Draft | 07/12/2023 | / |
8 | ICH & CDE | Draft | 12/12/2023 | / | |
9 | CDE | Draft | 12/12/2023 | / |
8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
In December 2023, the Chinese Pharmacopoeia Commission released the following draft standards.
No. | Draft standard | Type | Consultation |
1 | General chapter | 07/12/2023-06/01/2024 | |
2 | 1) 4061 Determination of Surface Energy on Metal Coating 2) 4255 Determination of Bisphenol A Monomer Leaching from Metal Coating 3) 4051 Determination of Pressure Resistance Performance of Metal Cans 4) 4050 Determination of Corrosion Resistance Performance of Metal 5) 4055 Determination of Fracture Strength of Metal 6) 4054 Determination of Opening Force of Aluminum-plastic Covers 7) 4057 Determination of the Thickness of Aluminum and Aluminum Alloy Anodic Oxide Films 8) 4062 Determination of Contact Angle of Metal Coatings 9) 4254 Determination of Formaldehyde Monomer Leaching from Metal Coatings 10) 4252 Determination of Acrylic Monomer Leaching from Metal Coatings 11) 4060 Determination of Toughness of Metal Tubes for Ointment 12) 4058 Determination of Continuity of Metal Interior Coatings | General chapter | 07/12/2023-06/01/2023 |
3 | General chapter | 26/12/2023-31/03/2024 | |
4 | Determination of Ethylene Oxide in Pharmaceutical Packaging Materials | General chapter | 07/12/2023-07/03/2024 |
5 | 1) 4210 Determination of Vinyl Chloride Monomer and Vinylidene Chloride Monomer in Plastics 2) 4213 Determination of Oil Permeability of Plastic Containers 3) 4215 Determination of Ethylene Glycol in Plastic Containers 4) 4212 Determination of Ethanol Permeability of Plastic Containers 5) 4028 Determination of Transmittance of Plastics 7) 4216 Determination of Total Terephthalic Acid in Plastic Containers 8) 4026 Determination of Pressure Resistance Performance of Plastics 9) 4027 Determination of Dimensional Changes on Heating 10) 4208 Determination of Acetaldehyde in Plastics 11) 4205 Test for Decolorization of Plastics 12) 4025 Determination of Drop Impact Resistance Performance of Plastics | General chapter | 07/12/2023-07/03/2024 |
6 | Determination of Solvent Residues in Pharmaceutical Packaging Materials | General chapter | 07/12/2023-07/03/2024 |
7 | Determination of Insoluble Particles in Pharmaceutical Packaging Materials | General chapter | 07/12/2023-07/03/2024 |
8 | Determination of Leachables from Pharmaceutical Packaging Materials | General chapter | 07/12/2023-07/03/2024 |
9 | TCM monograph | 07/12/2023-07/03/2024 | |
10 | TCM monograph | 07/12/2023-07/01/2024 | |
11 | TCM monograph | 07/12/2023-07/03/2024 | |
12 | TCM monograph | 12/12/2023-12/03/2024 | |
13 | Guideline | 12/12/2023-12/03/2024 | |
14 | Particle Size and Particle Size Distribution Determination | General chapter | 12/12/2023-12/03/2024 |
15 | General chapter | 12/12/2023-12/03/2024 | |
16 | TCM monograph | 13/12/2023-13/03/2024 | |
17 | TCM monograph | 13/12/2023-13/03/2024 | |
18 | TCM monograph | 13/12/2023-13/03/2024 | |
19 | TCM monograph | 13/12/2023-13/03/2024 | |
20 | TCM monograph | 13/12/2023-13/03/2024 | |
21 | TCM monograph | 13/12/2023-13/03/2024 | |
22 | TCM monograph | 13/12/2023-13/03/2024 | |
23 | TCM monograph | 13/12/2023-13/03/2024 | |
24 | TCM monograph | 13/12/2023-13/03/2024 | |
25 | Biologic monograph | 13/12/2023-13/03/2024 | |
26 | Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus Type 1 Nucleic Acid Detection Kit | Biologic monograph | 13/12/2023-13/03/2024 |
27 | TCM monograph | 13/12/2023-13/03/2024 | |
28 | Excipient monograph | 13/12/2023-13/01/2024 | |
29 | Excipient monograph | 13/12/2023-13/01/2024 | |
30 | Excipient monograph | 13/12/2023-13/03/2024 | |
31 | Excipient monograph | 13/12/2023-13/03/2024 | |
32 | Excipient monograph | 13/12/2023-13/01/2024 | |
33 | Excipient monograph | 13/12/2023-13/03/2024 | |
34 | Excipient monograph | 13/12/2023-13/03/2024 | |
35 | Excipient monograph | 13/12/2023-13/03/2024 | |
36 | Excipient monograph | 13/12/2023-13/03/2024 | |
37 | Excipient monograph | 13/12/2023-13/01/2024 | |
38 | Kangle Rhinitis Tablets (Kangle Biyan Pian) (Standard Code: WS3-B-2423-97-14) | TCM monograph | 13/12/2023-13/03/2024 |
39 | Kangle Rhinitis Tablets (Kangle Biyan Pian) (Standard Code: WS3-B-2423-97-11) | TCM monograph | 13/12/2023-13/03/2024 |
40 | Kangle Rhinitis Tablets (Kangle Biyan Pian) (Standard Code: WS3-B-2423-97-6) | TCM monograph | 13/12/2023-13/03/2024 |
41 | TCM monograph | 13/12/2023-13/03/2024 | |
42 | Shenrong Heart-nourishing Kidney-benefiting Capsules (Shenrong Yangxin Yishen Jiaonang) | TCM monograph | 14/12/2023-14/01/2024 |
43 | TCM monograph | 14/12/2023-14/01/2024 | |
44 | TCM monograph | 14/12/2023-14/03/2024 | |
45 | TCM monograph | 14/12/2023-14/03/2024 | |
46 | General chapter on biologics | 20/12/2023-20/03/2024 | |
47 | Chemical drug monograph | 20/12/2023-20/03/2024 | |
48 | Guideline on Microbiological Testing of Pharmaceutical Packaging Materials | Guideline | 21/12/2023-21/03/2024 |
49 | Excipient monograph | 21/12/2023-21/03/2024 | |
50 | Excipient monograph | 21/12/2023-21/03/2024 | |
51 | Excipient monograph | 21/12/2023-21/03/2024 | |
52 | Excipient monograph | 21/12/2023-21/01/2024 | |
53 | Excipient monograph | 21/12/2023-21/03/2024 | |
54 | TCM monograph | 21/12/2023-21/03/2024 | |
55 | Chemical drug monograph | 22/12/2023-22/01/2024 | |
56 | Chemical drug monograph | 22/12/2023-22/01/2024 | |
57 | Chemical drug monograph | 25/12/2023-25/01/2024 | |
58 | Excipient monograph | 26/12/2023-26/03/2024 | |
59 | 1) Letrozole | Chemical drug monograph | 27/12/2023-27/03/2024 |
60 | General chapter | 27/12/2023-27/03/2024 | |
61 | Biologic monograph | 28/12/2023-28/03/2024 | |
62 | Human Immunoglobulin (pH4) for Intravenous Injection, Freeze-dried | Biologic monograph | 28/12/2023-28/03/2024 |
63 | Human Hepatitis B Immunoglobulin (pH4) for Intravenous Injection | Biologic monograph | 28/12/2023-28/03/2024 |
64 | Human Hepatitis B Immunoglobulin (pH4) for Intravenous Injection, Freeze-dried | Biologic monograph | 28/12/2023-28/03/2024 |
65 | Determination of Nuclease Residue (Fluorescence-based Nucleic Acid Method) | Biologic monograph | 28/12/2023-28/03/2024 |
66 | Guideline for Neutralizing Antibody Detection Based on Pseudovirus | Biologic monograph | 28/12/2023-28/03/2024 |
67 | Preparation and Quality Control of Animal Cell Matrix for Biological Product Production | General chapter | 28/12/2023-28/03/2024 |
68 | Preparation and Quality Control of Animal Cell Matrix for Biological Product Testing | General chapter | 28/12/2023-28/03/2024 |
69 | General chapter | 28/12/2023-28/03/2024 | |
70 | Biologic monograph | 28/12/2023-28/03/2024 | |
71 | TCM monograph | 28/12/2023-28/03/2024 | |
72 | TCM monograph | 28/12/2023-28/03/2024 | |
73 | TCM monograph | 28/12/2023-28/03/2024 | |
74 | Chemical drug monograph | 29/12/2023-29/03/2024 | |
75 | Chemical drug monograph | 29/12/2023-29/03/2024 | |
76 | Chemical drug monograph | 29/12/2023-29/03/2024 | |
77 | Imported Traditional Chinese Medicine Ingredient of Hydnocarpus Seeds | TCM monograph | 29/12/2023-29/03/2024 |
78 | Imported Traditional Chinese Medicine Ingredient of Hyoscyamus Niger | TCM monograph | 29/12/2023-29/03/2024 |
79 | Imported Traditional Chinese Medicine Ingredient of Asafoetida | TCM monograph | 29/12/2023-29/03/2024 |
80 | Biologic monograph | 29/12/2023-29/03/2024 | |
81 | Biologic monograph | 29/12/2023-29/03/2024 | |
82 | Biologic monograph | 29/12/2023-29/03/2024 | |
83 | Biologic monograph | 29/12/2023-29/03/2024 | |
84 | Biologic monograph | 29/12/2023-29/03/2024 | |
85 | Biologic monograph | 29/12/2023-29/03/2024 | |
86 | Biologic monograph | 29/12/2023-29/03/2024 | |
87 | Biologic monograph | 29/12/2023-29/03/2024 | |
88 | Biologic monograph | 29/12/2023-29/03/2024 |
