Monthly Recap: China Pharmaceutical Regulatory Updates | February 2023

by Grace Wang Mar 07, 2023

Editor's Notes: Monthly recap is a collection of China's recent pharmaceutical laws, regulations, policies, and standards 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.


The following are the regulatory updates in Feb. 2023:

1. China NMPA Issues TCM Registration Rules

2. China CDE Rolls Out Pharmaceutical Guidelines

3. Chinese Pharmacopoeia Commission Issues Draft Standards

1. China NMPA Issues TCM Registration Rules

On Feb. 10, 2023, NMPA released the Special Rules for the Administration of Traditional Chinese Medicine (TCM) Registration (hereafter referred to as the Special Rules), which will take effect on July 1, 2023.

The Special Rules has 11 chapters1:

Chapter I: General Provisions

Chapter II: TCM Classification and Marketing Authorization Review

Chapter III: Appropriate Application of Human Use Evidence

Chapter IV: Innovative TCM

Chapter V: Improved new TCM

Chapter VI: Combination TCM in Ancient Classical Prescription

Chapter VII: Medicines with the Same Name and Formulation

Chapter VIII: Post-approval Changes

Chapter IX: TCM Registration Standards

Chapter X: Drug Name and Medication Package Insert

Chapter XI: Supplementary Provisions 

The Special Rules requires that TCMs, like chemical drugs and biological products, should be clinical-value-oriented. The Special Rules also recognizes TCMs’ special characteristic—abundant human use experience embodying effectiveness and safety information.

2. China CDE Rolls Out Pharmaceutical Guidelines

In Feb. 2023, China CDE published a series of home-drafted guidelines and a guideline of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) with Chinese translation.

No.

Guidelines

Authority

Status

Issued

Enforced

1

Technical Guidelines on Chemistry, Manufacturing, and Control (CMC) Studies and Evaluations of Oncolytic Virus Products (Trial)

CDE

In force

13/02/2023

13/02/2023

2

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

CDE

In force

13/02/2023

13/02/2023

3

Technical Guidelines on Clinical Trials for Therapeutic Drugs for Primary Biliary Cholangitis (PBC)

CDE

In force

13/02/2023

13/02/2023

4

ICH Guideline M13A: Bioequivalence for Immediate-release Solid Oral Dosage Forms and its Chinese Translation

ICH & CDE

Draft

14/02/2023

/

5

Technical Guidelines for Quality Attribute Researches on Chewable Tablets (Chemical Drugs) (Trial)

CDE

In force

14/02/2023

14/02/2023

6

Technical Guidelines on Clinical Evaluation of In Vivo Therapeutic Radiopharmaceuticals

CDE

In force

15/02/2023

15/02/2023

7

Guidelines on Design and Protocol of Drug Real-world Evidence Study (Trial)

CDE

In force

16/02/2023

16/02/2023

8

Guidelines on Communication About Drug Registration Application Supported by Real-world Evidence

CDE

In force

16/02/2023

16/02/2023

9

Technical Guidelines for CMC Studies on Generic Chemical Ophthalmic Solutions

CDE

In force

16/02/2023

16/02/2023

10

Technical Guidelines on Microbial Limit Researches for Non-sterile Chemical Drugs, Active Pharmaceutical Ingredients, and Excipients (Trial)

CDE

In force

21/02/2023

21/02/2023

11

Technical Guidelines on CMC Researches on Chemically Synthesized Peptide Drug Products

CDE

In force

21/02/2023

21/02/2023

12

Technical Guidelines on Clinical R&D of Type-2 Diabetes Mellitus Drugs for Adults

CDE

In force

21/02/2023

21/02/2023

3. Chinese Pharmacopoeia Commission Issues Draft Standards

In Feb. 2023, Chinese Pharmacopoeia Commission released the following draft standards for public comments.

No.

Draft Standards

Type

Issued

1

4204 Determination of Extractables of Pharmaceutical Packaging Materials

Determination method

07/02/2023

2

Geshan Xiaoji Keli (granules)

Monograph of finished dosage form

07/02/2023

3

1) 5100 Glass Containers for Pharmaceutical Packaging;

2) 5101 Glass Infusion Bottles;

3) 5102 Glass Ampoules;

4) 5103 Glass Sleeves for Prefilled Syringes;

5) 5104 Glass Barrels of Prefilled Syringes;

6) 5105 Glass Components of Injector Pens;

7) 5106 Glass Medicine Bottle.

General chapter

09/02/2023

4

Angong Niuhuang Shuan (suppositories)

Monograph of finished dosage form

09/02/2023

5

1) 4003 Determination of Internal Forces of Glass Containers;

2) 4017 Determination of Resistance to Internal Stress of Glass Containers;

3) 4018 Determination of Breaking Force of Glass Ampoules;

4) 4019 Determination of Glass Containers’ Thermal Shock and Its Strength; Determination of Glass Containers’ Thermal Shock and the Strength of Thermal Shock

5) 4020 Determination of Vertical Axis Deviation and Circular Runout of Glass Containers;

6) 4021 Determination of Linear Thermal Expansion Coefficients of Glass;

7) 4022 Determination of Average Linear Thermal Expansion Coefficients of Glass;

8) 4023 Determination of Light-shielding Properties of Colored Glass Containers;

9) 4024 Determination of Capacity of Glass Containers;

10) 4201 Determination of Water Resistance of Glass Particles at 121°C;

11) 4202 Determination of Water Resistance of the Internal Surface of Glass Containers;

12) 4203 Determination of Diboron Trioxide in Glass.

Determination method

09/02/2023

6

Xinmaitong Pian (tablets)

Monograph of finished dosage form

16/02/2023

7

1) 5200 Rubber Closures for Pharmaceutical Packaging;

2) 5201 Rubber Closures for Injections’ Packaging;

3) 5202 Rubber Closures for Oral Dosage Forms’ Packaging.

General chapter

16/02/2023

8

1) 4219 Determination of Volatile Sulfide in Rubber Closures;

2) 4220 Ash Content in Rubber Closures;

3) 4221 Water Content in Rubber Closures;

4) 4222 Silicone Oil on the Surface of Rubber Closures;

5) 4223 Special Residues in Silicone Rubber Closures.

Determination method

16/02/2023

 Regulation/policy coming into effect in Mar. 2023:

Contact BaiPharm if you need more details of the summarized contents above.

Read more:

Monthly Report: New Drug Approvals in China | February 2023

Grace Wang
ChemLinked Regulatory Analyst & Editor
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