Monthly Recap: China Pharmaceutical Regulatory Updates | November 2022

by Grace Wang Dec 09, 2022

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.



Contents

1. China NMPA Renews Classifications of Sodium Hyaluronate Products

2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks

3. China NMPA Consults on Chemical API Registration Renewal Regulation

4. China NMPA Announces Drug Banned from Online Sales

5. China NMPA Requires Online Drug Sellers and E-commerce Platforms to File Information

6. China NMPA to Enforce Drug Retail Delivery Regulations

7. China NMPA Consults on Drug MAH’s Main Responsibilities

8. China CDE Implements Work Procedures for Changes During Drug Review

9. China CDE Implements Rules on Timekeeping for Drug Review

10. China Pushes Forward the Real World Study on Drugs in Hainan

11. CDE Issues a Series of Guidelines

12. Chinese Pharmacopoeia Commission Releases Drafts of Drug Standards

1. China NMPA Renews Classifications of Sodium Hyaluronate Products

China issues the new classifications of sodium hyaluronate products on Nov. 14 with immediate effect. Based on intended use and mechanism of action, the products are classified into drugs, medical devices, drug-led combination products, and device-led combination products.1 Find out the detailed classifications at BaiPharm's report.

2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks

On Nov. 30, NMPA announced that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted electronically in compact disks with no paper required. The requirement will start on Jan. 1, 2023.2 Learn about relevant requirements at BaiPharm's report.

3. China NMPA Consults on Chemical API Registration Renewal Regulation

On Nov. 4, NMPA released the draft of Announcement on the Administration of Chemical API Registration Renewal for comments. A one-year transition period will be given from the date when the draft takes effect.3

After the transition period, all manufacturers of approved APIs shall apply for registration renewal no later than 6 months before the expiration of the approval number/notification. Find out detailed timing requirements at BaiPharm's report.

4. China NMPA Announces Drug Banned from Online Sales

After consulting the draft list in early November, NMPA issued the List of Drug Banned from Online Sales (1st Version), which includes vaccines, blood products, anesthetics, psychiatric drugs, etc.4 The list took effect on Dec. 1, 2022, the same day when the Administrative Measures for Supervising Online Sales of Drugs came into force.  More details at BaiPharm's report.

5. China NMPA Requires Online Drug Sellers and E-commerce Platforms to File Information

On Nov. 30, NMPA required third-party online drug transaction platforms to file records at local provincial-level medical products administrations. The record information includes:

Ÿ   The platform's company name

Ÿ   Legal representative person;

Ÿ   Unified social credit code;

Ÿ   Website name;

Ÿ   Domain name, etc.5

Online drug sellers shall report the following information to local medical products administrations:

Ÿ   The seller's company name;

Ÿ   Website name;

Ÿ   Application (App) name;

Ÿ   IP address;

Ÿ   Domain name;

Ÿ   Drug manufacturing license or drug supplying license, etc.

Read about details at BaiPharm’s report.

6. China NMPA to Enforce Drug Retail Delivery Regulations

On Nov. 30, NMPA released the Sixth Appendix to Good Supply Practices (GSP) for Pharmaceuticals: Quality Management for Drug Retail Delivery. The Appendix applies to the delivery after drug retail transactions, including online transactions.

Delivery covers selecting, verifying, packing, sealing, sending, and transporting the drug needed by the customer to the required place until the sign after receipt.

The Appendix requires drug retailers to take effective quality management measures and ensure the drug information is traceable during delivery.6 Find out details at BaiPharm's report.

7. China NMPA Consults on Drug MAH's Main Responsibilities

On Nov. 29, NMPA released the draft of Administrative Rules on Supervising Drug Marketing Authorization Holders on Carrying Out Main Responsibilities. The Rules specifies MAH's obligations including arranging qualified persons responsible for manufacturing, quality control, and pharmacovigilance, as well as ensuring GMP-compliant storage and the traceability of drugs, etc.7 Find more about MAH system in China at BaiPharm's insight.

8. China CDE Implements Work Procedures for Changes During Drug Review

On Nov. 11, China CDE issued the Work Procedures for Changes During the Review of Drug Registration Application (Trial) with immediate effect. The Work Procedures stipulates that during the review of marketing authorization application, the applicant should withdraw the application if major change impacting safety, efficacy, and/or quality controllability is made, and resubmit after additional researches.8

9. China CDE Implements Rules on Timekeeping for Drug Review

On Nov. 16, CDE released the Administrative Rules on Stopping and Resuming the Time Clock for Drug Review. The clock stops due to situations like CDE asking the applicant to submit supplemental documents, and other necessary scenarios. The clock will continue when the required documents are submitted to CDE.9

10. China Pushes Forward the Real World Study on Drugs in Hainan

On Nov. 18, the Provisions for Real World Study on Drugs came into effect. According to the Provisions, if one drug is in urgent need and approved to be only imported to Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, the applicant can apply for China's national marketing authorization by using the real world data in the zone.10 Learn more at BaiPharm's insight.

11. CDE Issues Guidelines

In November 2022, CDE issued 19 guidelines:

No.

Guidelines

Status

Issuance

Enforce-ment

1

Technical Guidelines on the Design and Evaluation of the Taste of Pediatric Drugs

Effective

Nov. 2

Nov. 2

2

Technical Guidelines on Clinical Development of Pediatric Anti-cancer Drugs

Draft

Nov. 8

/

3

Technical Guidelines on the Chemistry, Manufacturing, and Control (CMC) Studies on Alcohol-induced Dose Dumpling (ADD) Trial for Oral Modified-release Generic Drugs

Effective

Nov. 8

Nov. 8

4

Q&A on Dissolution Profile in the "Technical Guidelines on Researches on CMC Changes to Approved Drugs (Trial)"

Effective

Nov. 8

Nov. 8

5

Technical Guidelines on Benefit-risk Evaluation for New Drugs

Draft

Nov. 8

/

6

Technical Guidelines on the Clinical Development of Bispecific Antibody Drugs for Cancer

Effective

Nov. 14

Nov. 14

7

Technical Guidelines on Clinical Trials for Drugs Treating Lupus Nephritis

Draft

Nov. 16

/

8

Technical Guidelines on Clinical Trials for Drugs Treating Chronic Kidney Diseases

Draft

Nov. 16

/

9

Technical Guidelines on New Traditional Chinese Combination Medicines Related to Malicious Cancer Treatment

Draft

Nov. 17

/

10

Technical Guidelines on Clinical Trials for Drugs Treating Multiple Sclerosis

Draft

Nov. 18

/

11

Technical Guidelines on Clinical Trials for Drugs Treating Dry Eyes

Draft

Nov. 18

/

12

Technical Guidelines on Clinical Trials for Drugs Treating Atopic Dermatitis

Draft

Nov. 18

/

13

Guidelines on General Considerations for Patients' Engagement in Drug Development (Trial)

Effective

Nov. 25

Nov. 25

14

Technical Guidelines on Clinical Trials for Photodynamic Therapy

Draft

Nov. 25

/

15

Technical Guidelines on Bioequivalence Studies on Tenofovir Alafenamide Fumarate Tablets

Effective

Nov. 25

Nov. 25

16

Technical Guidelines on Bioequivalence Studies on Loratadine Tablets

Effective

Nov. 25

Nov. 25

17

Technical Guidelines on Bioequivalence Studies on Tadalafil Tablets

Effective

Nov. 25

Nov. 25

18

Technical Guidelines on Bioequivalence Studies on Amphotericin B Liposome for Injection

Effective

Nov. 25

Nov. 25

19

ICH Guideline Q5A(R2) on Viral Safety Evaluation of Biotechnology and its Chinese Translation

Draft

Nov. 28

/

12. Chinese Pharmacopoeia Commission Releases Drafts of Drug Standards

Chinese Pharmacopoeia Commission issued the following drafts of drug standards for comments.

No.

Draft of Standards

Type

Issuance

1

Edetate Disodium

Standard of excipient standard

Nov. 4

2

Determination of Gas Impurities-Gas Tube Method

Determination method

Nov. 8

3

Determination of Gas Moisture-Dew Point Method

Determination method

Nov. 8

4

Guidelines on Biological Evaluations and Trial Selection of Pharmaceutical Packaging Materials

Guideline

Nov. 21

5

Guidelines on Validation of Alternatives of Microbial Testing for Drugs

Guideline

Nov. 29

6

Calcium Dobesilate

Standard of active pharmaceutical ingredient (API)

Nov. 29

7

Nitrendipine

Standard of API

Nov. 29

8

Testing of Burkholderia Cepacia Complex

Testing method

Nov. 29

9

Guidelines on Microbial Whole-genome Sequencing

Guideline

Nov. 29

 Please contact us if you need more details of the summarized contents above.

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Grace Wang
ChemLinked Regulatory Analyst / Editor
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