Monthly Recap: China Pharmaceutical Regulatory Updates | August 2022

by Grace Wang Sep 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.

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

Contents:

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

  2. China NMPA Publishes the 57th List of RLDs

  3. China NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol

  4. China NMPA to Adopt ICH E8 (R1) and E14 Guidelines

  5. CDE Seeks Public Comments on Pharmaceutical Guideline Drafts

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

On Aug. 26, NMPA granted OTC status to Omeprazole Enteric-coated Tablets, a widely used drug for gastrointestinal diseases. According to Menet Database, Omeprazole's sales value in China's retail market reached 1.068 billion yuan (circa 155 million USD) in 2020.

China NMPA has approved 5,041 OTC drugs, including 1,111 chemical drugs, 3,921 traditional Chinese medicines, and 9 biological products. Among the approved OTC drugs, 805 were former prescription drugs and granted OTC status via Rx-to-OTC switch, while 192 of the 805 have both Rx and OTC statuses.

Related: How to Sell OTC Drugs to China via Cross-Border E-Commerce

2. China NMPA Publishes the 57th List of RLDs

On Aug. 26, China NMPA released the 57th List of Reference Listed Drugs (RLDs). The list covers 86 RLDs, including Alcon Laboratories' Balanced Salt Solution and Novartis Europharm Limited's Dabrafenib Mesylate Capsules. RLDs are used to see if generic drugs are equivalent with them in quality and efficacy.

3. China NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol

On Aug. 9, China National Healthcare Commission (NHC) added Azvudine Tablets, to COVID-19 Pneumonia Diagnosis and Treatment Protocol (9th Edition). The recommended dosage is 5 mg (five 1mg tablets) per day for a course no longer than 14 days. The drug, developed by  Chinese company Genuine Biotech, is priced at 270 per bottle with 35 tablets. Thus, one course of Azvudine costs no more than 540 yuan.

4. China NMPA to Adopt ICH E8 (R1) and E14 Guidelines

On Aug. 12, China NMPA announced that clinical trials starting on or after July 31, 2023 shall comply with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)'s E8 (R1) Guideline: General Considerations for Clinical Studies and E14 Guideline: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs. ICH E8 Guideline will then no longer be in force. NMPA's adoption of the ICH guidelines manifests a further step in the process of aligning China's drug registration standards with international ones.

5. CDE Seeks Public Comments on Pharmaceutical Guideline Drafts

In August, China Center for Drug Evaluation (CDE) published 11 drafts of pharmaceutical guidelines, involving clinical trials and real world data.

No.

Draft

Release Date

1

Technical Guidelines on Clinical Trials for Therapeutic Drugs for Primary Biliary Cholangitis

Aug. 1

2

Common Pharmaceutical Issues and Relevant Technical Requirements for the Meeting Prior to Phase III Clinical Trials for Innovative Chemical Drugs

Aug. 2

3

Technical Guidelines on Conducting Patient-centric Clinical Trials

Aug. 9

4

Technical Guidelines on Designing Patient-centric Clinical Trials

Aug. 9

5

Technical Guidelines on Evaluating Benefits and Risks of Patient-centric Clinical Trials

Aug. 9

6

Technical Guidelines on the Application of Physiological Pharmacokinetic Models in Developing Pediatric Drugs

Aug. 17

7

Implementation Advice and Chinese Version of ICH M10 Guideline: Bioanalytical Method Validation and Study Sample Analysis

Aug. 17

8

Guidelines on Communications for Drug Registration Applications Supported by Real World Evidence

Aug. 17

9

Technical Guidelines on Clinical Trials for Drugs for Respiratory Syncytial Virus Infection

Aug. 18

10

Technical Guidelines on Pharmaceutical Researches on Generic Eye Drops (Consultation Draft)

Aug. 29

11

Writing Guidelines for Chemical Drugs' Medication Package Inserts and Labels

Aug. 30

6. Chinese Pharmacopoeia Commission Consults on Drug Standards

In August, Chinese Pharmacopoeia (ChP) Commission released drafts of three testing methods and nine national standards on active pharmaceutical ingredients (APIs) and finished chemical drugs. The drafts, after consultation, are expected to become general chapters and monographs in the next edition of Chinese Pharmacopoeia.

No.

Draft

Release Date

1

Harmonized Protocol Between Pharmaceutical Excipient Monographs and ICH Q3C Guideline

Aug. 1

2

General Chapter: Determination of Moisture in Gas—Dew Point Method

Aug. 2

3

General Chapter: Determination of Impurities in Gas—Gas Detector Tube Method

Aug. 3

4

General Chapter: Dropping Point Detection Method

Aug. 4

5

Monograph: Kitasamycin

Aug. 9

6

Monograph: Kitasamycin Tablets

Aug. 9

7

Monograph: Tosufloxacin Tosilate

Aug. 9

8

Monograph: Tosufloxacin Tosilate Tablets

Aug. 9

9

Monograph: Tosufloxacin Tosilate Capsules

Aug. 9

10

Monograph: Tosufloxacin Tosilate Dispersible Capsules

Aug. 9

11

Monograph: Omeprazole

Aug. 30

12

Monograph: Bleomycin A5 Hydrochloride

Aug. 31

13

Monograph: Bleomycin A5 Hydrochloride for Injection

Aug. 31

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Grace Wang
ChemLinked Regulatory Analyst
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