Monthly Recap: China Pharmaceutical Regulatory Updates | July 2022

by Grace Wang Aug 05, 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.

For more details about the summarized contents below, please send an enquiry to contact@chemlinked.com.


1. China's 7th Volume-based Procurement Includes 327 Drug Products

On July 18, China National Joint Drug Procurement Office announced the official list of 327 drug products for the 7th volume-based procurement (VBP).1 217 bid-winning companies will supply the products to public health institutions. Among the companies, 6 are international enterprises—Hetero Labs, Bracco Sine, Almirall, Sandoz, and Pfizer. Please refer to BaiPharm's previous report for more details.

2. China NMPA Grants One Rx-to-OTC Switch

On July 11, China NMPA granted the OTC status to a former prescription drug Glucosamine Potassium Sulfate Tablets.2 View China's OTC medicine list at BaiPharm Database. Find out how to sell OTC drugs to China via cross-border e-commerce at BaiPharm Insight/Webinar.

webinar-how-to-sell-otc-drugs-to-china-via-cross-border-e-commerce.pngChemLinked BaiPharm Webinar: How to Sell OTC Drugs to China via Cross-border E-commerce

3. China NMPA Issues the 56th List of RLDs

On July 22, China NMPA released the 56th list of reference listed drugs (RLDs), including Teva Pharmaceuticals' Floxapen, Novartis Japan K.K.'s Betoptic and other 72 drugs.3 RLDs are reference products to which that generic drugs shall be equivalent in quality and efficacy. View the RLD lists at BaiPharm Database.

chemlinked-baipharm-database.pngBaiPharm Database

4. China NMPA Implements Vaccine Manufacture & Distribution Rules

On July 8, China NMPA started implementing the Administrative Rules on Vaccine Manufacture and Distribution (hereafter referred to as the Rules).4 According to the Rules, China adopts the marketing authorization holder (MAH) system for vaccines. MAHs shall take the primary responsibilities for vaccine's safety, efficacy, and quality controllability, and manage the manufacture and distribution of vaccines. Check out more details at BaiPharm News.

5. China CDE Consults on Procedures for Starting For-cause Inspections

On July 7, CDE released the draft of Work Procedures for Initiating For-cause Inspections During Drug Review for public comments.5 For-cause inspections will be initiated by CDE if the drug application data are found to be suspiciously inauthentic or the drugs are reported to have problems during the review, and the issues need to be verified on site. When necessary, CDE can conduct sample tests.

Related Article: China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications

6. China CDE Releases Q&As on Immediate Report of Adverse Drug Reactions (ADRs) in Clinical Trials

On July 19, CDE consulted on the Q&As on the Immediate Report of Safety Data During Drug Clinical Trials (Version 2.0).6 CDE clarifies the scopes of drugs and clinical trials for which applicants should immediately report the unexpected and severe ADRs that are confirmed/suspected to be relevant to the test drugs.

The involved drugs cover traditional Chinese medicines, chemical drugs, and biological products, including vaccines.

The clinical trials include:

  • Phase I/II/III clinical trials related to drug registration;

  • Bioequivalence studies approved according to investigational new drug (IND) applications;

  • Phase IV clinical trials particularly required in the drug approval document;

  • Clinical trials required for drugs with conditional approval.

  • Clinical trials required for marketed drugs that apply for adding a new target group or a new indication.

  • Clinical trials required for marketed drugs that have major variations (e.g. new dosage form, new administration route, new manufacturing technique, etc.)

Time limits7 for the immediate reports:

Ÿ   For unexpected and severe ADRs that are deadly or life-threatening, the applicant should report them as soon as possible—no later than the 7th day from the first knowledge* of the ADRs. The applicant should complete the follow-up information in the subsequent 8 days after the report date.

Ÿ   For unexpected and severe ADRs that are neither deadly nor life-threatening, the applicant should report them as soon as possible—no later than the 15th day from the first knowledge of the ADRs.

*The first knowledge means that the applicant has known about the ADRs for the first time. The day when the applicant gets the first knowledge is defined as the zeroth day.

Related Article: China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports

7. Pharmaceutical Guidelines/Standards

No.

Guidelines/Standards

Authority

Status

Release Date

1

Guidelines on General Considerations for Organizing Patients to Joining in Drug Development

CDE

Draft

July 6

2

Technical Guidelines on Antibody-drug Conjugates (ADCs)' Non-clinical Researches

CDE

Draft

July 6

3

Technical Guidelines on Alcohol-induced Dose-dumpling Tests for Oral Modified-release Formations of Generic Drugs

CDE

Draft

July 7

4

Guidelines on the Design and Plan Framework of Real World Studies on Drugs

CDE

Draft

July 7

5

Technical Guidelines on Bioequivalence Studies on Amphotericin B Liposome for Injection

CDE

Draft

July 7

6

Guidelines on Clinical R&D of New Drugs for Acute Myeloid Leukemia (AML)

CDE

Draft

July 19

7

Technical Guidelines on Drug Registration Based on Animal Rules

CDE

Draft

July 22

8

Guidelines on Blinded Clinical Trials of Drugs

CDE

Draft

July 25

9

ICH M12 Guideline on Drug Interaction Studies

CDE

Draft

July 29

10

Monograph: Lincomycin Hydrochloride Injection

Chinese   Pharmacopoeia (ChP) Commission

Revised   Draft

July 7

11

Monograph: Clindamycin Phosphate Injection

ChP Commission

Revised Draft

July 7

12

Monograph: Calcium Carbonate

ChP   Commission

Draft

July 7

13

Monograph: Nitrogen

ChP Commission

Draft

July 7

14

Guidelines on Determining the Flowability of Powder

ChP   Commission

Draft

July 7

15

9650 Research Guidelines on Sealing Properties of Pharmaceutical Packaging Systems

ChP Commission

Draft

July 11

16

*No. 16-40 are draft standards of pharmaceutical packaging materials

5510 General Chapter on Prefilled Syringes

ChP   Commission

Draft

July 11

17

5511 General Chapter on Glass Barrels of Prefilled Syringes

ChP Commission

Draft

July 11

18

5512 General Chapter on Plastic Barrels of Prefilled Syringes

ChP   Commission

Draft

July 11

19

5513 General Chapter on Stainless Steel Needles of Prefilled Syringes

ChP Commission

Draft

July 11

20

4040 Test for Luer Taper of Prefilled Syringes

ChP   Commission

Draft

July 11

21

4041 Sealing Property Test for Protective Caps of Prefilled Syringes

ChP Commission

Draft

July 11

22

4042 Pull-off Force Test for Protective Caps of Prefilled Syringes

ChP   Commission

Draft

July 11

23

4043 Sealing Property Test for Pistons of Prefilled Syringes

ChP Commission

Draft

July 11

24

4044 Unscrewing Torque Determination for Luer Lock Rigid Tip Caps of Prefilled Syringes

ChP   Commission

Draft

July 11

25

4045 Torsion Resistance Determination for Adapter Collars of Prefilled Syringes

ChP Commission

Draft

July 11

26

4046 Pull-off Force Determination for Adapter Collars of Pre-filled Syringes

ChP   Commission

Draft

July 11

27

4209 General Chapter on the Determination of Ethylene Oxide in Pharmaceutical Packaging Materials

ChP Commission

Draft

July 11

28

4226 Determination of Tungsten Dissolution Amount in Prefilled Syringes

ChP   Commission

Draft

July 11

29

4227 Determination of Silicone Oil in Prefilled Syringes

ChP Commission

Draft

July 11

30

5200 General Chapter on Rubber Closures for Pharmaceutical Packaging

ChP   Commission

Draft

July 13

31

5201 General Chapter on Rubber Closures for Injections' Packaging

ChP Commission

Draft

July 13

32

5202 General Chapter on Rubber Closures for Oral Dosage Forms' Packaging

ChP   Commission

Draft

July 13

33

4204 Determination of Extractables and Leachables of Pharmaceutical Packaging Materials

ChP Commission

Draft

July 14

34

4206 Determination of Insoluble Particles in Pharmaceutical Packaging Materials

ChP   Commission

Draft

July 15

35

4214 Determination of Metal Elements and Ions in Pharmaceutical Packaging Materials

ChP Commission

Draft

July 16

36

4219 Determination of Volatile Sulfide in Rubber Closures

ChP   Commission

Draft

July 17

37

4220 Determination of Ash Content in Rubber Closures

ChP Commission

Draft

July 18

38

4221 Determination of Water Content in Rubber Closures

ChP   Commission

Draft

July 19

39

4222 Determination of Silicone Oil on the Surface of Rubber Closures

ChP Commission

Draft

July 20

40

4223 Determination of Special Residues in Silicone Rubber Closures

ChP   Commission

Draft

July 21

41

Monograph: Minocycline Hydrochloride Tablets

ChP Commission

Revised Draft

July 20

42

Monograph: Bismuth Subnitrate

ChP   Commission

Draft

July 20

43

Monograph: Bismuth Subnitrate Tablets

ChP Commission

Draft

July 20

44

Monograph: Magnesium Sulfate Injection

ChP   Commission

Revised   Draft

July 20

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Grace Wang
ChemLinked Regulatory Analyst
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