Monthly Recap: China Pharmaceutical Regulatory Updates | January 2023

by Grace Wang Feb 06, 2023

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 Q3D (R2) Guideline on Elemental Impurities

NMPA

In force

Jan. 29, 2023

Jan. 29, 2023

2

ICH M10 Guideline on Bioanalytical Method Validation

NMPA

In force

Jan. 29, 2023

Jan. 29, 2023

3

R&D Guidelines on the Oral Combination Drugs for Type 2 Diabetes Mellitus

CDE

Draft

Jan. 3, 2023

/

4

ICH E19 Guideline on a Selective Approach to Safety Data Collection in Specific Late-stage Pre-approval or Post-approval Clinical Trials, its Chinese translation, and implementation advice

CDE

Draft

Jan. 6, 2023

/

5

ICH M11 Guideline on Clinical Electronic Structured Harmonized Protocol (CeSHarP), its technical specifications, Chinese translation, and implementation advice

CDE

Draft

Jan. 6, 2023

/

6

Technical R&D Guidelines on Improved Traditional Chinese Medicines

CDE

Draft

Jan. 6, 2023

/

7

Clinical R&D Guidelines on New Drugs for Chronic Lymphocytic Leukemia

CDE

Draft

Jan. 19, 2023

Jan. 19, 2023

8

Guidance for Electronic Common Technical Document (eCTD) Implementation V1.1

CDE

Draft

Jan. 29, 2023

/

9

Standards for eCTD Validation V1.1

CDE

Draft

Jan. 29, 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

4044 Determination Method for the Unscrew Torque of Prefilled Syringe's Conical Semi-steel Luer Lock Cap

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

5510 Prefilled Syringes

General Chapter

Jan. 4, 2023

12

5511 Semi-assembled Prefilled Syringes

General Chapter

Jan. 4, 2023

13

4209 Determination of Ethylene Oxide in Pharmaceutical Packaging Materials

General Chapter

Jan. 11, 2023

14

Determination Method for Dropping Point

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

5302 Plastic Containers and Components for Eye Drops

General Chapter

Jan. 16, 2023

18

5303 Plastic Containers and Components for Liquid for External Use

General Chapter

Jan. 16, 2023

19

5305 Plastic Containers and Components for Oral Liquid

General Chapter

Jan. 16, 2023

20

5306 Plastic Containers and Components for Oral Solid Dosage Forms

General Chapter

Jan. 16, 2023

21

4211 Determination Method for Moisture Content and Moisture Absorption Rate of Desiccant in the Moisture-proof Combination Caps

Determination Method

Jan. 16, 2023

22

4028 Determination Method for Optical Transmittance of Plastics

Determination Method

Jan. 16, 2023

23

4025 Testing Method for Drop Resistance of Plastics

Testing Method

Jan. 16, 2023

24

4205 Testing Method for Discoloration of Plastics

Testing Method

Jan. 16, 2023

25

4208 Determination Method for Acetaldehyde in Plastics

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

4215 Determination Method for Ethylene Glycol in Plastics

Determination Method

Jan. 16, 2023

29

4216 Determination Method for Terephthalic Acid in Plastics

Determination Method

Jan. 16, 2023

30

Mannitol

Pharmaceutical Excipient Standard

Jan. 16, 2023

31

1142 Testing Method for Pyrogen

Testing Method

Jan. 31, 2023

32

1144 Testing Method for Pressor Substances

Testing Method

Jan. 31, 2023

33

1145 Testing Method for Antihypertensive Substances

Testing Method

Jan. 31, 2023

34

1148 Testing Method for Hemolysis and Coagulation

Testing Method

Jan. 31, 2023

35

1205 Bioassay Method for Vasopressin

Bioassay Method

Jan. 31, 2023

36

1206 Assay Method of Cytochrome C Activity

Assay Method

Jan. 31, 2023

37

Methacrylic Acid-Methyl Methacrylate Copolymer (1:2)

Pharmaceutical Excipient Standard

Jan. 31, 2023

38

Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion

Pharmaceutical Excipient Standard

Jan. 31, 2023

39

Amino Methacrylate Copolymer

Pharmaceutical Excipient Standard

Jan. 31, 2023

40

Partially Neutralized Methacrylic Acid and Ethyl Acrylate Copolymer

Pharmaceutical Excipient Standard

Jan. 31, 2023

41

Methacrylic Acid-Ethyl Acrylate Copolymer

Pharmaceutical Excipient Standard

Jan. 31, 2023

42

Methacrylic Acid-Methyl Methacrylate Copolymer (1:2)

Pharmaceutical Excipient Standard

Jan. 31, 2023

 Contact BaiPharm if you need more details of the summarized contents above.

Read more:

BaiPharm Monthly Report: New Drug Approvals in China | Jan. 2023

Search for China's Pharma Regulations in BaiPharm Regulatory Database

Grace Wang
ChemLinked Regulatory Analyst / Editor
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