Monthly Recap: China Pharmaceutical Regulatory Updates | April 2024

by Angelita Hu May 13, 2024

Editor's Notes: Monthly recap is a collection of China's laws, regulations, standards, and policies on chemical drugs and biological products. Generally, the regulatory updates are from 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 April 2024.

1. China NMPA Adopts Electronic Documentation for Administrative Licensing in Drug Registration

On April 3, 2024, the National Medical Products Administration (NMPA) announced the adoption of electronic documentation for administrative licensing in drug registration. As of May 1, 2024, the NMPA will digitize administrative licensing documents related to drug registration, such as national drug standards, notices of termination for registration applications, and notifications of approval for the importation of reference drugs. These electronic documents will hold the same legal validity as their paper counterparts, ensuring a streamlined and effective process for drug registration.

2. China NMPA Rolls out the 79th RLD List

On April 16, 2024, the NMPA rolls out the 79th list of reference listed drugs (RLDs). The list encompasses 64 products, including Thiamine Hydrochloride Injection/Vitamin B1 Injection, Mavacamten capsules and Iloperidone Tablets. For the full OTC catalog, please visit BaiPharm Database.

3. China Enhances Supervision and Management of Drug Operations

On April 22, 2024, the National Medical Products Administration (NMPA) issued an announcement regarding the further enhancement of the supervision and management of drug operations. The announcement consists of thirteen articles that provide specific provisions on the admission management of drug operation enterprises, the management of drug operation licenses, the standardization of drug operation practices, and the supervision and management of drug warehousing and logistics. 

4. China Expedites Process for Transferring Overseas Drug Manufacturing Sites to China

On April 23, 2024, the NMPA published the Notice on Optimizing Marketing Authorization Applications for Transferring Manufacturing Sites of Approved Overseas Drugs to China.

The notice outlines the following three points.

1) In the case of drugs that have already received approval in China but are currently manufactured outside of China, if the applicant intends to transfer the manufacturing site to China, they must adhere to the requirements for and procedures of submitting drug marketing authorization applications.

2) For drugs mentioned in Point 1), for the marketing authorization application in China, the applicant is permitted to submit the original overseas marketing authorization dossier as supporting documentation, along with the research dossiers related to the transfer of the manufacturing site. The dossier requirements will be published by the Center for Drug Evaluation (CDE). 

3) For originator chemical drugs and biological products mentioned in Point 1, their marketing authorization applications will be admitted into the priority review process by the NMPA.

5. China NHC Undertakes the Management of Human Genetic Resources

On April 25, 2024, the China National Health Commission (NHC) issued an announcement, stating that starting from May 1, 2024, the management of human genetic resources would be undertaken by the National Health Commission instead of the Ministry of Science and Technology (MOST). The existing application process and platform (https://apply.hgrg.net) remains unchanged.

6. NMPA Grants Seven Rx-to-OTC Switches

In April 2024, NMPA granted over-the-counter (OTC) status to seven previously approved prescription drugs. They are:

1) Fuxuekang Granules (Fuxuekang Keli)

2) Xueshan Weibao Capsules (Xueshan Weibao Jiaonang)

3) Bismuth potassium Citrate Capsules

4) Weishuning Tablets (Weishuning Pian)

5) Qiushui Jianpi Powder (Qiushui Jianpi San)

6) Danzhi Xiaoyao Capsules (Danzhi Xiaoyao Jiaonang)

7) Linglianhua Granules (Linglianhua Keli)

For the complete OTC catalog, please refer to BaiPharm Database.

7. China Releases Pharmaceutical Guidelines

In April 2024, China unveiled the following guidelines on chemical drugs and biological products.

No

Guidelines

Authority

Status

Issued

Enforced

1

Technical Guidelines on Clinical Trial Design of Biosimilar Semaglutide Injection in Weight Management Indications

CDE

Draft

2024/04/01

/

2

Chemical, Manufacturing, and Controls (CMC) of Self-evaluation Reports on Class 3 Chemical Drug Registration Applications

CDE

Draft

2024/04/02

/

3

Summary of Bioequivalence Studies on Generics

CDE

In   force

2024/04/11

2024/04/11

4

CDE's Detailed Work Rules on Adding Pediatric Medication Information to the Medication Package Inserts of Approved Drugs (Trial)

CDE

In   force

2024/04/18

2024/04/18

5

Guidelines on Writing Chemistry, Manufacturing, and Controls (CMC) Study Application Dossiers for Combination Traditional Chinese Medicines (TCM) Regulated as Ancient Classic Prescriptions (Trial)

CDE

In   force

2024/04/23

2024/04/23

8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

In April 2024, the Chinese Pharmacopoeia Commission released 94 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods.

Parts of the 94 draft standards

No.

Draft standard

Type

Consultation

1

Zhengqing Fengtongning Pian

Monograph-TCM

2024/04/01-2024/07/01

2

Guidelines for Packaging Systems of Drug Blister Packaging

Guideline

2024/04/01-2024/07/01

3

4041 Examination Method of Sealability for Components of Prefilled Syringes

General chapter

2024/04/01-2024/07/01

4

4040 Examination Method of Luer Conical Fitting of Prefilled Syringes

General chapter

2024/04/01-2024/07/01

5

4042 Determination of Opening Performance for Tip Cap/Needle Shield of Prefilled Syringes

General chapter

2024/04/01-2024/07/01

6

4043 Determination of Performance for Luer Lock Adaptor Collar of Prefilled Syringes

General chapter

2024/04/01-2024/07/01

7

4226 Determination of ExtractableTungsten for Prefilled Syringes

General chapter

2024/04/01-2024/07/01

8

4227 Determination of Silicone Oil Content for Prefilled Syringes

General chapter

2024/04/01-2024/07/01

9

5510 General Chapter of Prefilled Syringes

General chapter

2024/04/01-2024/07/01

10

5511 General Chapter of Subassembled Prefilled Syringes

General chapter

2024/04/01-2024/07/01

11

Wenglitong Keli

Monograph-TCM

2024/04/02-2024/07/02

12

Fufang Shouwu Buye

Monograph-TCM

2024/04/02-2024/07/02

13

Poloxamer 188

Monograph-excipient

2024/04/07-2024/07/07

14

Poloxamer 407

Monograph-excipient

2024/04/07-2024/07/07

15

Suanzaoren Peifangkeli

Monograph-TCM

2024/04/08-2024/05/09

16

Chaosuanzaoren Peifangkeli

Monograph-TCM

2024/04/08-2024/05/09

17

Sodium Alginate

Monograph-excipient

2024/04/09-2024/07/09

18

Ethanol

Monograph-excipient

2024/04/09-2024/05/10

19

Eugenol

Monograph-excipient

2024/04/09-2024/07/09

20

Dimethicone

Monograph-excipient

2024/04/09-2024/07/09

21

Sorbitol

Monograph-excipient

2024/04/09-2024/07/09

22

Anhydrous Citric Acid

Monograph-excipient

2024/04/09-2024/07/09

23

Ferrosoferric Oxide

Monograph-excipient

2024/04/09-2024/07/09

24

Olive Oil

Monograph-excipient

2024/04/09-2024/05/10

25

0251 Pharmaceutical Excipients

General chapter

2024/04/09-2024/07/09

26

Compound Amino Acid Injection (14AA)

Monograph-chemical drug

2024/04/09-2024/07/09

27

1143 Test for Bacterial Endotoxi

General chapter

2024/04/09-2024/05/10

28

1209 Biological Assay of Chorionic Gonadotrophin

General chapter

2024/04/09-2024/05/10

29

9301 Guidelines for Application of Safety Tests for Injection

Guideline

2024/04/09-2024/07/09

30

Polyethylene Glycol 400

Monograph-excipient

2024/04/10-2024/07/10

31

Polyethylene Glycol 300 (For Injection)

Monograph-excipient

2024/04/10-2024/07/10

32

Polyethylene Glycol 400 (For Injection)

Monograph-excipient

2024/04/10-2024/07/10

33

Polyethylene Glycol 600

Monograph-excipient

2024/04/10-2024/07/10

34

Polyethylene Glycol 1000

Monograph-excipient

2024/04/10-2024/07/10

35

Polyethylene Glycol 1500

Monograph-excipient

2024/04/10-2024/07/10

36

Polyethylene Glycol 4000

Monograph-excipient

2024/04/10-2024/07/10

37

Polyethylene Glycol 6000

Monograph-excipient

2024/04/10-2024/07/10

38

Povidone K30

Monograph-excipient

2024/04/15-2024/05/16

39

Squalene

Monograph-excipient

2024/04/15-2024/07/15

40

Hydrogenated Vegetable Oil

Monograph-excipient

2024/04/15-2024/07/15

41

Anhydrous Tert-butyl alcohol

Monograph-excipient

2024/04/17-2024/07/17

42

Compound Vitamin B Tablets

Monograph-chemical drug

2024/04/18-2024/07/18

43

Trometamolum

Monograph-excipient

2024/04/22-2024/07/22

44

Xylitol

Monograph-excipient

2024/04/22-2024/07/22

 Contact BaiPharm if you are interested in learning more about the draft standards or other drug registration regulations in China.

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Angelita Hu
ChemLinked Content Manager
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