Monthly Recap: China Pharmaceutical Regulatory Updates | May 2024

by Angelita Hu Jun 11, 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 May 2024:

1. China CDE Solicits Public Comments on the 82nd RLD List

On May 6, China CDE consulted on the draft of the 82nd list of reference listed drugs (RLDs). The list encompasses 28 products, such as Diazepam nasal spray, Aprepitant for Oral Suspension, Ciclesonide Nasal Spray, etc.

2. China CDE Releases Dossier Requirements for Imported Chemical Drugs' Transfer to Domestic Production

On May 9, China CDE released the Dossier Requirements for Marketing Authorization Applications of Approved Imported (Chemical) Drugs to Be Transferred to Domestic Production. According to the regulation, when transferring approved imported drugs to domestic production, the domestic applicant is required to submit a marketing authorization application following the guidelines for chemical generic drugs. The application should be prepared and submitted in accordance with the current version of the "M4: Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use," following the specified CTD format and sequence of sections. A clear statement indicating the transfer of approved imported drugs to domestic production, along with the corresponding drug approval number, must be included in the special declaration section.

3. China CDR Consults on Principles for Determining the Scope of Indications for OTC Drugs

On May 10, China's Center for Drug Reevaluation under the NMPA announced to invite feedback on the draft Principles for Determining the Scope of Indications for OTC Drugs. This document outlines the specific principles for indications such as common ailments, recurring conditions and chronic illnesses. Feedbacks can be submitted via email to zycdr@cdr-adr.org.cn until June 12th, 2024.

4. China NMPA Consults on Requirements for Re-Registration Applications of Domestically Manufactured Drugs

On May 13, China's NMPA initiated a public consultation on the Notice Concerning the Procedures and Dossier Requirements for Re-Registration Applications of Domestically Manufactured Drugs. This regulation requires domestic manufacturers of drugs and APIs to submit their re-registration applications online via the NMPA's service portal (https://zwfw.nmpa.gov.cn) between twelve and six months before their drug approval documents expire. The notice also outlines the necessary dossiers, the re-registration application procedures, and the review process stipulated by the competent authorities.

5.   China Consults on Guidelines for Switching Prescription Drugs to OTC Status

On May 20, 2024, China's Center for Drug Reevaluation under the NMPA released the draft Guidelines on the Scope of Applications for Switching Prescription Drugs to Over-the-Counter (OTC) Drugs for public consultation. The draft outlines the key criteria and exclusions for such drug switching.

According to the draft, MAHs or the agents designated by MAHs of imported drugs can apply for switching the prescription drugs to OTC if the drugs meet the following conditions:

  • The drugs comply with the evaluation guidance principles and technical requirements for switching to OTC status.

  • The drugs are suitable for consumer self-awareness, self-judgment, self-medication, and self-monitoring.

  • The drugs have been widely used clinically in China with a good safety profile (including preparations or ingredients).

6. China Changes Controls on Certain Drugs Including Dextromethorphan

On May 7, 2024, several Chinese government agencies - the NMPA, Ministry of Public Security (MPS), and NHC —jointly announced changes to the classification of certain ingredients and drugs under China's psychotropic drugs catalog:

  • Dextromethorphan (including salts and single-ingredient preparations), nalfurafine (including salts, isomers and single-ingredient preparations), lorcaserin (including salts, isomers and single-ingredient preparations), and compound diphenoxylate preparations will be moved to Category II Psychotropic Drugs.

  • Midazolam active pharmaceutical ingredients (including salts and isomers) and injections will be reclassified from Category II to Category I Psychotropic Drugs. 

At the end of May, China's NMPA and NHC further clarified that beginning onJuly 1, 2024, the research, procurement, mailing, transportation, import, and export of the affected ingredients and drugs will be governed by the Drug Administration Law and the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances. Furthermore, the NMPA and NHC outlines enforcement rules regarding the manufacture, labeling, supply, and traceability of the affected ingredients and drugs. 

7. NMPA Grants Two Rx-to-OTC Switches

In May 2024, NMPA granted over-the-counter (OTC) status to two previous prescription drugs. They are:

  • Zhongsheng Tablets (Zhongsheng Pian)

  • Qiangshen Tablets (Qiangshen Pian)

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

8. China Releases Key Points for Addressing Malpractice in Drugs and Medical Services in 2024

On May 27, in a unified effort to improve the integrity and quality of the healthcare sector, China's NHC, together with 14 other ministries, issued a detailed notice outlining the Key Points for Correcting Malpractice in the Purchase and Sale of Drugs and Medical Services in 2024.

Key highlights include "accelerating volume-based procurement to streamline circulation," "enhancing internal management and standardizing business service practices," "strengthening supervision and law enforcement to combat illegal activities" and “concentrating on illegal activities and violations in areas such as assisted reproduction, medical testing, health screenings, cosmetic procedures, and internet-based healthcare services.”

9. China NMPA Requires the Addition of Pediatric Use Information to the Instructions of Seven Drugs

On May 27, China's NMPA announced to require the addition of pediatric use information to the instructions of seven drugs including Flumazenil, Colchicine, Methotrexate, Dasatinib, Posaconazole, and Levetiracetam

The marketing authorization holders for these seven products are obligated to submit supplementary applications to the NMPA, revise the sections on indications and dosage in the instructions, and improve safety information. If these revisions impact drug labeling, the labels should be updated accordingly. Upon approval of the supplementary application, the MAHs must promptly gather and report adverse reaction information and ensure effective risk control and pharmacovigilance for pediatric drugs.

10. China NMPA Implements International Guidelines for Drug Registration

On May 28, the NMPA announced its decision to adopt the ICH guidelines Q2(R2) on Validation of Analytical Procedures and Q14 on Analytical Method Development.

Effective from November 24, 2024, all relevant studies conducted by applicants are required to adhere to the principles outlined in Q2(R2)/Q14 guidelines. These guidelines provide three options for method development, allowing applicants to choose between traditional or enhanced methods, or a combination of both.

Q14 addresses the entire lifecycle of analytical methods and change management, involving aspects covered in Q12, such as Established Conditions (EC). Applicants submitting registration applications that simultaneously involve Q12-related content are required to comply with the applicable announcements regarding Q12.

11. China NMPA Rolls Out the 80th RLD List

On May 28, the NMPA rolled out the 80th list of reference listed drugs (RLDs). The list encompasses 44 products, including Niraparib Tosilate Capsules, Belumosudil Mesylate Tablets, Hydromorphone Hydrochloride Tablets, etc. For the full OTC catalog, please visit BaiPharm Database.

12. China Seeks Input on New Safety Manufacture Guidelines for Narcotic and Psychotropic Drug

On May 30, the Center for Special Drug Inspection of the NMPA called for public input on revised safety manufacture guidelines for anesthetic drugs, psychotropic substances, and drug precursors. Comments can be emailed to tsypjczx@163.com by June 6, 2024..

13. China Implements Procedures for Inclusion of Drugs in National Reimbursement Drug List (NRDL) 

On May 31, China's National Healthcare Security Administration (NHSA) announced the issuance and implementation of the Procedures for Determining the Inclusion of Drugs in the National Reimbursement Drug List (Trial) (hereinafter referred to as "Procedures").

The Procedures address cases where the names or dosage forms of drugs differ from the listings in the NRDL, such as those caused by renaming. In these instances, stakeholders believe that, according to the NRDL's related provisions, these drugs should be identified as either included in or excluded from the NRDL.

The determination process involves four key stages: application submission, application confirmation, expert review, and result publication.

14. China CDE to Keep Posting Pediatric Drug Approvals

On May 31, the CDE announced that it would persist in posting approvals for pediatric drugs with priority review the "Pediatric Drugs" section on its website. This aims to help research organizations in better grasping pediatric drug development. 

15. China Releases Pharmaceutical Guidelines

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

No

Guidelines

Authority

Status

Issued

Enforced

1

Technical Guidelines on Bioequivalence   Studies of Acetylcysteine Granules

CDE

In   force

2024/05/14

2024/05/14

2

Technical Guidelines on Bioequivalence Studies of Etomidate Medium and Long Chain Fat Emulsion Injection

CDE

In   force

2024/05/14

2024/05/14

3

Technical Guidelines on Bioequivalence Studies of Epalrestat Capsule

CDE

In   force

2024/05/14

2024/05/14

4

Technical Guidelines on Bioequivalence Studies of Thioctic Acid Capsule

CDE

In   force

2024/05/14

2024/05/14

5

Technical Guidelines on Bioequivalence Studies of Lidocaine and Prilocaine Cream

CDE

In   force

2024/05/14

2024/05/14

6

Technical Guidelines on Bioequivalence Studies of Azathioprine Capsule

CDE

In   force

2024/05/14

2024/05/14

7

Technical Guidelines on Bioequivalence Studies of Mercaptopurine Capsule

CDE

In   force

2024/05/14

2024/05/14

8

Technical Guidelines on Bioequivalence Studies of Regorafenib Capsule

CDE

In   force

2024/05/14

2024/05/14

9

Technical Guidelines on Bioequivalence Studies of Octreotide Acetate Microspheres for Injection

CDE

In   force

2024/05/14

2024/05/14

10

Technical Guidelines on Bioequivalence Studies of Omeprazole and Sodium Bicarbonate for Suspension

CDE

In   force

2024/05/14

2024/05/14

11

Technical Guidelines on Bioequivalence Studies of Omeprazole and Sodium Bicarbonate Capsule

CDE

In   force

2024/05/14

2024/05/14

12

Technical Guidelines on Bioequivalence Studies of Leuprorelin Acetate Micrspheres for Injection

CDE

In   force

2024/05/14

2024/05/14

13

Technical Guidelines on Bioequivalence Studies of Eltrombopag Olamine Tablet

CDE

In   force

2024/05/14

2024/05/14

14

Technical Guidelines on Bioequivalence Studies of Enzalutamide Soft Capsule

CDE

In   force

2024/05/14

2024/05/14

15

Technical Guidelines on Decentralized Clinical Trials in Clinical Research of Rare Disease Drugs

CDE

In   force

2024/05/28

2024/05/28

16

Technical Guidelines on Analysis and   Handling of SUSAR in Clinical Trials of Antineoplastic Drugs

CDE

Draft

2024/05/31

/

16. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

In May 2024, the Chinese Pharmacopoeia Commission released 163 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods.

Parts of the 163 draft standards

No.

Draft standard

Type

Consultation(yyyy-mm-dd)

1

Plasters

General chapter

2024/05/06-2024/07/06

2

Medium and Long Chain Fat Emulsion   Injection

Monograph-chemical drug

2024/05/07-2024/08/06

3

Tribasic Calcium Phosphate

Monograph-excipient

2024/05/10-2024/07/10

4

Sodium Methyl Hydroxybenzoate

Monograph-excipient

2024/05/10-2024/06/10

5

Sodium Ethyl Hydroxybenzoate

Monograph-excipient

2024/05/10-2024/07/10

6

Dimethyl Sulfoxide

Monograph-excipient

2024/05/10-2024/07/10

7

Hydrogenated Palm Oil

Monograph-excipient

2024/05/10-2024/08/09

8

Palm Oil

Monograph-excipient

2024/05/10-2024/08/09

9

Enterosoluble Vacant Gelatin Capsules

Monograph-excipient

2024/05/10-2024/07/10

10

Oleic Acid

Monograph-excipient

2024/05/10-2024/07/10

11

Vacant Gelatin Capsules

Monograph-excipient

2024/05/10-2024/06/10

12

Arginine Hydrochloride

Monograph-excipient

2024/05/10-2024/06/10

13

Dimethyl Ether

Monograph-excipient

2024/05/10-2024/07/10

14

Paraffin

Monograph-excipient

2024/05/10-2024/07/10

15

Ambrisentan Tablets

Monograph-chemical drug

2024/05/13-2024/07/13

16

Iopamidol

Monograph-chemical drug

2024/05/13-2024/07/13

17

Histidine Hydrochloride

Monograph-excipient

2024/05/29-2024/08/28

18

Phenol

Monograph-excipient

2024/05/29-2024/06/29

19

Polyoxyl 15 Hydroxystearate

Monograph-excipient

2024/05/31-2024/07/01

20

Mannitol

Monograph-excipient

2024/05/31-2024/07/01

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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