Monthly Recap: China Pharmaceutical Regulatory Updates | September 2022

by Grace Wang Oct 03, 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.

Contents:

  1. China SAMR to Permit Online Sales of Prescription Drugs Nationwide

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

  3. China NMPA Releases 183 RLDs

  4. China CFDI Consults on Inspection Guidance for Blood Products

  5. China NHSA Announces 343 Drugs Passing the Format Review for NRDL

  6. China CDE Releases Pharmaceutical Guidelines

  7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards and Guideline

1. China SAMR to Permit Online Sales of Prescription Drugs Nationwide

On Sept. 1, 2022, China State Administration for Market Regulation (SAMR) published the Administrative Measures for Supervising Online Sales of Drugs (hereafter referred to as the Measures), which will be enforced from Dec. 1, 2022. The Measures is the first official regulation that has permitted online sales of prescription (Rx) drugs nationwide.

To ensure the safety for selling drugs online, the Measures specifies regulatory requirements for online sellers and third-party online platforms. For example, online sellers are only allowed to sell prescription drugs to customers who show reliable and authentic prescriptions with their real names. For more details, please refer to BaiPharm's previous report.

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

On Sept. 20, China National Medical Products Administration (NMPA) granted OTC status to Santongshu Capsules, a former prescription drug. It is a traditional Chinese medicine (TCM) for relieving muscle pain. By far, 806 prescription drugs have obtained OTC status via Rx-to-OTC switches. Check China's OTC Drug Catalog at BaiPharm Database.

Related Article: How to Get China's Marketing Authorization for OTC Drugs

3. China NMPA Releases 183 RLDs

On Sept. 14, Sept. 27, and Sept. 30, China NMPA released the 58th, the 59th, and the 60th lists of reference listed drugs (RLDs) separately, altogether including 183 drugs. RLDs are reference drugs for evaluating generic drugs—generics should be equivalent to RLDs in quality and therapeutic efficacy. Check out China's RLD Catalog at BaiPharm Database.

Related Webinar: China's Quality and Therapeutic Equivalence Evaluations of Generic Drugs

4. China CFDI Consults on Inspection Guidance for Blood Products

On Sept. 15, Center for Food and Drug Inspection (CFDI) released the draft of Guidance for Inspecting Blood Product Manufacturing Sites (hereafter referred to as the Guidance). The Guidance applies to Good Manufacturing Practice (GMP) inspections of three categories of blood products: human albumin, human immunoglobulin products, and human coagulation factor products.

The inspection covers the below processes:

  • active ingredient and excipient management;

  • plasma collection;

  • plasma testing;

  • plasma packaging and labeling;

  • plasma storage and transportation;

  • plasma quality management;

  • manufacturing of blood product;

  • blood product quality management;

  • the warehouse entry management and sample retention of finished blood product.

5. China NHSA Announces 343 Drugs Passing the Format Review for NRDL

On Sept. 17, China National Healthcare Security Administration (NHSA) announced a list of 343 drugs which had passed the format review for entering the 2022 version of National Reimbursement Drug List (NRDL), a list of drugs covered by social health insurance.

The 343 drugs include China's first homegrown COVID-19 oral treatment drug Azvudine Tablets, Pfizer's COVID-19 Combination Therapy Nirmatrelvir Tablets and Ritonavir Tablets, as well as Roche's Risdiplam Powder for Oral Solution for treating the rare disease spinal muscular atrophy (SMA). The drugs passed the format review need to go through expert evaluation and price negotiation/bidding to finally enter the 2022 NRDL.

6. China CDE Releases Pharmaceutical Guidelines

The following table lists the guideline drafts released by Center for Drug Evaluation (CDE) in September.

No.

Guideline

Status

Release Date

Implementation Date

1

Technical Guidelines on Pharmaceutical Studies for Preventing the Abuse of Generic Solid Oral Opioid Drugs

Draft

Sept. 5

/

2

Technical Guidelines on Clinical Trials for Combination Drugs

Draft

Sept. 7

/

3

ICH Guideline Q3D (R2) on Elemental Impurities and its Chinese translation

Draft

Sept. 8

/

4

Technical Guidelines on Continuous Manufacturing of Solid Oral Chemical Drugs

Draft

Sept. 9

/

5

Technical Guidelines on Clinical Development for Antibody-drug Conjugates (ADCs) for Cancer Therapy

Draft

Sept. 15

/

6

Qualitative Methodology Guidelines on Extrapolation of Medication Data from Adults to Pediatric Patients

Draft

Sept. 19

/

7

Technical Guidelines on Quality Studies on Chewable Chemical Drugs

Draft

Sept. 26

/

8

Technical Guidelines on Clinical Development of New Drugs for Ovarian Cancer Therapy

Draft

Sept. 26

/

9

Technical Guidelines on Drugs' Clinical Dependence Studies

In force

Sept. 28

Sept. 28

     10Technical Guidelines on Non-clinical Studies on Drug Immunotoxicity     DraftSept. 30                /

7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards and Guideline

In September, Chinese Pharmacopoeia (ChP) Commission released a series of drafts,  including one drug naming guideline, 15 active pharmaceutical ingredient (API) standards, two excipient standards, and seven finished chemical drug standards. The standards, after consultation, are expected to become monographs in the next edition of Chinese Pharmacopoeia.

No.

Drug Guideline/Standard Draft

Product Category

Release Date

1

Non-proprietary Name Guidelines for Chemical Drugs

Finished chemical drug

Sept. 13

2

Monograph: Terbinafine Hydrochloride

API

Sept. 5

3

Monograph: Ciprofloxacin Hydrochloride

API

Sept. 5

4

Monograph: Tropicamide

API

Sept. 5

5

Monograph: Xylometazoline Hydrochloride

API

Sept. 5

6

Monograph: Doxapram Hydrochloride

API

Sept. 5

7

Monograph: Chlormethine Hydrochloride

API

Sept. 5

8

Monograph: Irbesartan

API

Sept. 7

9

Monograph: Lysine Hydrochloride and Calcium Hydrogen Phosphate Granules

Finished chemical drug

Sept. 7

10

Monograph: Prednisone

API

Sept. 7

11

Monograph: Glimepiride

API

Sept. 7

12

Monograph: Pancreatin Enteric-coated Tablets

Finished chemical drug

Sept. 8

13

Monograph: Pancreatin Enteric-coated Capsules

Finished chemical drug

Sept. 8

14

Monograph: Chlorobutanol

Excipient

Sept. 13

15

Monograph: Lumbrokinase

API

Sept. 13

16

Monograph: Lumbrokinase Enteric-coated Tablets

Finished chemical drug

Sept. 13

17

Monograph: Lumbrokinase Enteric-coated Capsules

Finished chemical drug

Sept. 13

18

Monograph: Pancreatin and Bile Enteric-coated Tablets

Finished chemical drug

Sept. 13

19

Monograph: Domperidone Tablets

Finished chemical drug

Sept. 13

20

Monograph: Tolperisone Hydrochloride

API

Sept. 28

21

Monograph: Acidum Oleanolicum

API

Sept. 28

22

Monograph: Calcium Dobesilate

API

Sept. 28

23

Monograph: Esmolol Hydrochloride

API

Sept. 28

24

Monograph: Carvedilol

API

Sept. 28

25

Monograph: White Beewax

Excipient

Sept. 28

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Grace Wang
ChemLinked Regulatory Analyst
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