Monthly Recap: China Pharmaceutical Regulatory Updates | June 2022

by Grace Wang Jul 06, 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

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1. CDE Issues the 2021 China Drug Evaluation Report

On June 1, CDE issued the 2021 China CDE Drug Evaluation Report, revealing that 47 innovator drugs were approved in 2021. BaiPharm has selected critical information and compiled it into a report, which covers the following information:

  1. The accepted, reviewed, and approved drug applications;

  2. The expedited approvals;

  3. Onsite inspections;

  4. Approved medical products in significant therapeutic areas;

  5. Disapproval reasons;

  6. Reforms of the drug review & approval system.

ChemLinked BaiPharm members can download the report for free at BaiPharm Insight.

2. CDE Publishes the 2021 Clinical Trial Report

On June 7, China Center for Drug Evaluation (CDE) published the 2021 Report on the Progress of Clinical Trials for New Drugs in China. According to the report, over 3,000 clinical trials were filed on CDE website, including 2,033 investigational and confirmatory clinical trials for new drugs.

During the past three years, among all the filed clinical trials, 54.6% and 40.4% were for chemical drugs and biological products respectively, according to annual average data. The indications were primarily neoplasms; the most popular targets were PD-1 and PD-L1.

3. CDE Consults on Communication Procedures for Pediatric Drug Applicants

On June 21, CDE released the Work Procedures for the Application and Administration of Communication on Pediatric Drugs for public comments. The Work Procedures applies to pediatric drugs in any of the following categories:

  1. Drugs in the List of Pediatric Drugs Encouraged for R&D and Registration Application;

  2. Drugs whose target group are children and the indications have been listed as rare diseases by NHC and other authorities or recognized as major infectious diseases by NHC.

  3. Class 1 innovator drugs or class 2 improved drugs specially developed for children, including chemical drugs, prophylactic biological products, and therapeutic biological products.

  4. Drugs with overseas marketing authorization and pediatric use approval that are applying for pediatric use authorization in China and have high value for meeting the clinical treatment needs for pediatric patients in China.

When filling in the communication meeting application form, the applicant should specify which category the pediatric drug belongs to. If meeting the relevant requirements, CDE will adjust the meeting from class II to class I, thus shortening the waiting period between the application and the meeting from 60 to 30 workdays.

4. CFDI Issues the 2021 Drug Inspection Report

5. NMPA Consults on GMP for Pharmaceutical Packaging Materials

6. NMPA Releases the 55th RLD List

7. NMPA Publishes Drug Traceability Specifications

8. NMPA Encourages Companies and Third Parties to Participate in Formulating & Revising TCM Standards

9. NMPA Supports Hong Kong and Macao MAHs to Entrust Drug Manufacture to Companies in the Greater Bay Area

10. NHC & NMPA Permits the Interim Import of Urgently-needed Drugs

11. NMPA Information Center and CFDI Issues Guidance for Digital Records of Vaccine Manufacture & Tests

12. NHSA to Adjust the 2022 National Reimbursement Drug List

13. Guidelines / Testing Methods / Standards


Guidelines  / Testing Methods / Standards



Release Date


Statistical Guidelines of Clinical Research on Rare Disease Drugs (Trial)


In force

June 6


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



June 17


Technical Guidelines on the Applicability of Single-arm Clinical Trials to Support the Marketing Authorization Applications for Anti-neoplastic Drugs



June 20


Technical Guidelines on Clinical Research on New Drugs for Chronic Lymphocytic Leukemia



June 20


Ÿ   Guidelines on Bioequivalence Studies of Tadalafil Tablets;

Ÿ     Guidelines on Bioequivalence Studies of Loratadine Tablets;

Ÿ     Guidelines on Bioequivalence Studies of Tenofovir Alafenamide Fumarate Tablets



June 22


Technical Guidelines on Clinical Trial Plan Changes During the Ongoing Trial for Drugs   (Trial)


In force

June 23


Technical Guidelines on Clinical Research on Drugs for Type 2 Diabetes in Adults



June 27


Technical Guidelines on Clinical Evaluation of In Vivo Therapeutic Radiopharmaceuticals



June 28


Pharmaceutical Excipient Standards of Magnesium Trisilicate

ChP Commission


June 1


Pharmaceutical Excipient Standards of Disodium Edetate

ChP Commission


June 1


Pharmaceutical Excipient Standards of Aluminium Hydroxide

ChP Commission


June 1


Pharmaceutical Excipient Standards of Powdered Cellulose

ChP Commission


June 1


Chinese Pharmacopoeia Guidelines on Biological Evaluation and Selection of Tests for Pharmaceutical Packaging Materials

ChP Commission


June 10


Chinese Pharmacopoeia Guidelines on Inspections of Pharmaceutical Packaging Materials

ChP Commission


June 16


National Drug Standards of Rabies Vaccines (Hamster Kidney Cell) for Human Use

ChP Commission


June 21


National Drug Standards of Rabies Vaccines (Vero Cell) for Human Use

ChP Commission


June 21


Twelve Determination Methods for Glass Containers Used in Pharmaceutical Packaging:

Ÿ   4003 Determination of Internal Pressure of Glass Containers;

Ÿ   4017 Determination of Internal Pressure Resistance of Glass Containers;

Ÿ   4018 Determination of Break Strength of Glass Ampoules;

Ÿ   4019 Thermal Shock Resistance of Glass Containers and Determination of Thermal Shock Strength;

Ÿ   4020 Determination of Vertical Axis Deviation and Circular Runout of Glass Containers;

Ÿ   4021 Determination of Linear Thermal Expansion Coefficients of Glass;

Ÿ   4022 Determination of Average Linear Thermal Expansion   Coefficients of Glass;

Ÿ   4023 Determination of Light-shielding Properties of Colored Glass Containers;

Ÿ   4024 Determination of Capacity of Glass Containers;

Ÿ   4201 Determination of Water Resistance of  Glass Particles at 121℃;

Ÿ   4202 Determination of Water Resistance of Internal Surface of Glass Containers;

Ÿ   4203 Determination of Diboron Trioxide in Glass

ChP Commission


June 28


Six General Chapters on Glass Containers:

Ÿ     5100 Glass Containers Used in Pharmaceutical Packaging;

Ÿ     5101 Glass Bottles for Infusion;

Ÿ     5102 Glass Ampoules;

Ÿ     5103 Glass Bottles for Injection;

Ÿ     5104 Glass Components in Pencil Injectors;

Ÿ     5105 Pharmaceutical Glass Bottles

ChP Commission


June 28

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Grace Wang
ChemLinked Regulatory Analyst
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