Monthly Recap: China Pharmaceutical Regulatory Updates | September 2021

by Grace Wang Oct 31, 2021

Editor's Note: Monthly recap is a brief collection of recently-issued drug laws, regulations and policies in China, especially those issued by National Medical Products Administration (NMPA) and its affiliating office Center for Drug Evaluation (CDE).

1. eCTD Format for Drug Marketing Application Dossiers

NMPA will start to accept the electronic common technical document (eCTD) format for drug application dossiers on Dec. 29, 2021.1 Currently, the eCTD format is only applicable to Class 1 and Class 5.1 chemical drugs, and Class 1 therapeutic and prophylactic biological products.

The format is NOT mandatory but alternative, so drug applicants can stay with the current method—submitting compact disks containing dossiers. Read more about the eCTD requirements.

China eCTD Application Scope:

Marketing Authorization Application Dossiers for Medical Products

Class 1 chemical drug: An innovative chemical drug that has never been granted marketing authorization in or outside China.

Class 5.1 chemical drug: An innovative or improved chemical drug with overseas marketing authorization and applying for marketing authorization in China. The improved drug shall have distinct clinical advantages.

Class 1 therapeutic biological product: An innovative therapeutic biological product that has never been granted marketing authorization in or outside China.

Class 1 prophylactic biological product: An innovative vaccine that has never been granted marketing authorization in or outside China.

2. Medical Device or IVD Reagent Regulations

2.1. NMPA Underlines Points for Attention on Implementing Administrative Measures for Medical Device Registration and Filing and Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing.

Before the two measures took effect on Oct. 1, 2021, NMPA pointed out noteworthy items on Sept. 29.2

For medical devices under the review but not yet approved before the implementation of the two measures, NMPA will continue the review and grant qualified devices according to the previous regulations.

For medical devices involving biological testing in their biological evaluation, the biological testing report shall be submitted with the marketing authorization application. If the report is from laboratories outside China, the applicant shall provide quality assurance documents proving that the laboratory complies with Good Laboratory Practice (GLP) requirements.

Medical devices imported to China shall be registered/filed by overseas registration/filing applicants. Medical devices manufactured by international companies in China shall be registered/filed by Chinese manufacturers.

2.2. NMPA Rolls Out the List of Medical Devices Exempted from Clinical Evaluation3 and the List of In Vitro Diagnostic Reagents Exempted from Clinical Trials4

The two lists, both released by NMPA on Sept. 18, allow stakeholders to spare themselves from conducting clinical evaluation/trials if the products are eligible for exemption.

A total of 1,010 categories of Class II/Class III medical devices and 423 categories of Class II/Class III IVD reagents are exempted from clinical evaluation or trials. Click here for exemption conditions and corresponding submission requirements.

2.3. NMPA Releases Format Requirements for Medical Devices' or IVD Reagents' Registration Application Dossiers and Approval Documents

Format Requirements for

Registration Application Dossiers and Approval Documents

Medical Device5

IVD Reagent6

Medical Device Registration Certificate (Template) in the People's Republic of China

Medical Device Variation Application/Filing Documents (Template) in the People's Republic of China

NMPA Feedback (Template) on the Review of the Clinical Trials for Medical Devices

 Format Requirements for Medical Device's Registration Application Dossiers and Approval Documents

 Requirements and Instructions on Medical Device's Registration Application Dossiers

 Requirements and Instructions on Medical Device's Renewal Application Dossiers

 Requirements and Instructions on Medical Device's Variation Filing/Registration Application Dossiers

 Requirements and Instructions on Medical Device's Clinical Trial Application Dossiers

 List of Essential Principles of Safety and Performance of Medical Devices

Medical Device (IVD Reagent) Registration Certificate (Template) in the People's Republic of China

Medical Device (IVD Reagent) Variation Application/Filing Documents (Template) in the People's Republic of China

Format Requirements for Medical Device (IVD Reagent)'s Registration Application Dossiers and Approval Documents

Requirements and Instructions on IVD Reagent's Registration Application Dossiers

Requirements and Instructions on IVD Reagent's Renewal Application Dossiers

Requirements and Instructions on IVD Reagent's Variation Filing/Registration Application Dossiers

List of Essential Principles of Safety and Performance of IVD Reagents

For English translations of the specific content in the regulatory documents above, welcome to contact us via contact@chemlinked.com.

2.4. Guidelines on Medical Devices and IVD Reagents

Guidelines

Medical Device7

Technical Guidelines on the Clinical Evaluation of Medical Devices

Technical Guidelines on Deciding Whether to Conduct Clinical Trials for Medical Devices

Technical Guidelines on the Equivalence of Medical Devices in Clinical Evaluation

Technical Guidelines on the Clinical Evaluation Report for Medical Device's Registration Application

Technical Guidelines on Comparing Clinical-Evaluation-Exempted Medical Devices and Approved Devices

The First Part of Inspection Guidelines on Animal Test Research for Medical Device Registration: Decision-making Principles

The Second Part of Inspection Guidelines on Animal Testing Research for Medical Device Registration: Testing's Design and Quality Assurance During Implementation

IVD Reagent8

Technical Guidelines on the Clinical Evaluation of Clinical-Trial-Exempted IVD Reagents

2.5. NMPA Releases Medical Device Industry Standards

On Sept. 9, NMPA released List of Medical Device Industry Standards9, which includes 63 standards with numbers, names, application scopes and implementation dates. The standards involve various medical devices, including face masks and relevant supplemental applications for treating sleep apnea.

2.6. NMPA, NHC and NHSA Stipulates Unique Device Identifiers (UDI)

Unique Device Identifiers have been implemented on 69 medical devices since Jan. 1 this year. Class 3 IVD reagents are also required to be labeled by UDIs, according to NMPA, National Health Commission (NHC) and National Healthcare Security Administration (NHSA).10

Since June 1, 2022, the 69 medical devices and Class 3 IVD reagents are required to adopt UDIs. Other medical devices are also encouraged by the authorities to do the same.

Applicants shall upload the stock keeping units’ or higher-level packages' UDIs to the Medical Device UDI Database, ensuring that the data is authentic, accurate, complete and traceable.

To ensure the UDI data is authentic, accurate, complete and traceable, for designated medical devices, applicants shall submit the stock keeping units' UDIs to the Registration Management System during first-time registration, renewal application or variation application.

3. Rx-to-OTC Switch

On Sept. 27, NMPA granted Aloe Vera Pearl Capsules, a formerly prescription (Rx) drug, over-the-counter (OTC) status.11

Rx-to-OTC Switch in China | Sept. 2021

Drug name

Strength

OTC Class

Aloe Vera Pearl Capsules (Pinyin: Luhui Zhenzhu Jiaonang)

0.5g/capsule

Class A

Marketing authorization holders (MAHs) of the drug shall submit supplemental applications to provincial medical products administrations for labeling changes.

The MAHs shall also notify the changes to relevant healthcare institutions and suppliers. The English version of China's OTC catalog will be uploaded to BaiPharm Database.

4. A Collection of Sept. Guidelines Released by NMPA or CDE

Guidelines Released by NMPA or CDE in Sept. 2021

No.

Guidelines

Authority

Release Date

1

Technical Inspection Guidelines on Comparing the Clinical Evaluations of the Same Type of Intravascular Catheters

NMPA

Sept. 7

2

Technical Guidelines on the Clinical Evaluation of Clinical-Trial-Exempted IVD Reagents

NMPA

Sept. 24

3

The First Part of Inspection Guidelines on Animal Test Research for Medical Device Registration: Decision-making Principles

NMPA

Sept. 27

4

The Second Part of Inspection Guidelines on Animal Testing Research for Medical Device Registration: Testing's design and Quality Assurance During Implementation

NMPA

Sept. 27

5

Technical Guidelines on Clinical Evaluation of Medical Devices

NMPA

Sept. 28

6

Technical Guidelines on Deciding Whether to Conduct Clinical Trials for Medical Devices

NMPA

Sept. 28

7

Technical Guidelines on Medical Device Equivalence in Clinical Evaluation

NMPA

Sept. 28

8

Technical Guidelines on Clinical Evaluation Report in Medical Device's Registration Application

NMPA

Sept. 28

9

Technical Guidelines on Comparing Clinical-Evaluation-Exempted Medical Devices and Approved Devices

NMPA

Sept. 28

10

Clinical Trial Design Guidelines on Liraglutide for Weight Management (Consultation Draft)

CDE

Sept. 1

11

Guidelines on Customized Implementation of "ICH E18 Guideline on Genomic Sampling and Management of Genomic Data" and "CH M3 (R2) and Q&A on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (Consultation Draft)

CDE

Sept. 1

12

Technical Guidelines on Pharmacokinetic Study of the Clinical Trials for Single and Multiple Ascending Doses of Innovative Chemical Drugs (Consultation Draft)

CDE

Sept. 3

13

Technical Guidelines on the Clinical Trials for Therapeutic or Prophylactic New Drugs Against COVID-19 (Trial) (Consultation Draft)

CDE

Sept. 3

14

Guidelines on Data Management and Statistical Analysis Plan for the Clinical Trials of Drugs (Consultation Draft)

CDE

Sept. 3

15

Guidelines on Using the Patient Reported Outcome in the Clinical Trials of Drugs (Consultation Draft)

CDE

Sept. 3

16

Technical Guidelines on Pediatric Drug Information in the Medication Package Inserts of Chemical Drugs and Therapeutic Biological Products (Trial)

CDE

Sept. 3

17

Guidelines on Designing Clinical Trials for Biosimilars of Cetuximab Solution for Infusion (Consultation Draft)

CDE

Sept. 8

18

Guidelines on Randomized Controlled Clinical Trials for Drugs (Consultation Draft)

CDE

Sept. 8

19

Guidelines on Comprehensive Analysis of Drugs' Effectiveness in Clinical Research (Consultation Draft)

CDE

Sept. 8

20

Technical Guidelines on the Clinical Trials for Direct Acting Antiviral Drugs for Chronic Hepatitis C (Consultation Draft)

CDE

Sept. 10

21

Technical Guidelines on the Clinical Trials for Attention Deficit Hyperactivity Disorder (ADHD) Drugs (Trial)

CDE

Sept. 13

22

Technical Guidelines on the Clinical Trials for Improved New Pediatric Chemical Drugs (Trial)

CDE

Sept. 13

23

ICH E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs (Consultation Draft) and Its Chinese Translation

CDE

Sept. 16

24

Guidelines on Centralized Statistical Monitoring of Clinical Trials (Consultation Draft)

CDE

Sept. 16

25

Technical Guidelines for Bioequivalence Studies of Ebastine Tablets

CDE

Sept. 17

26

Technical Guidelines for Bioequivalence Studies of Propofol Medium and Long Chain Fat Emulsion Injection

CDE

Sept. 17

27

Technical Guidelines for Bioequivalence Studies of Quetiapine Fumarate Tablets

CDE

Sept. 17

28

Technical Guidelines for Bioequivalence Studies of Clozapine Tablets

CDE

Sept. 17

29

Technical Guidelines for Bioequivalence Studies of Erlotinib Hydrochloride Tablets

CDE

Sept. 17

30

Technical Guidelines for Bioequivalence Studies of Afatinib Dimaleate Tablets

CDE

Sept. 17

31

Technical Guidelines for Bioequivalence Studies of Lercanidipine Hydrochloride Tablets

CDE

Sept. 17

32

Technical Guidelines for Bioequivalence Studies of Potassium Chloride Sustained-release Tablets

CDE

Sept. 17

33

Technical Guidelines for Bioequivalence Studies of Benazepril Hydrochloride Tablets

CDE

Sept. 17

34

Technical Guidelines for Bioequivalence Studies of Clopidogrel Hydrogen Sulphate Tablets

CDE

Sept. 17

35

Technical Guidelines for Bioequivalence Studies of Ezetimibe Tablets

CDE

Sept. 17

36

Technical Guidelines for Bioequivalence Studies of Simvastatin Tablets

CDE

Sept. 17

37

Technical Guidelines for Bioequivalence Studies of Methotrexate Tablets

CDE

Sept. 17

38

Technical Guidelines for Bioequivalence Studies of Sorafenib Tosylate Tablets

CDE

Sept. 17

39

Technical Guidelines for Bioequivalence Studies of Orally Disintegrating Sildenafil Citrate Tablets

CDE

Sept. 17

40

Technical Guidelines for Bioequivalence Studies of Ursodeoxycholic Acid Capsules

CDE

Sept. 17

41

Technical Guidelines on Risk Management Plans for Marketing Authorization Applications for CAR-T Products (Consultation Draft)

CDE

Sept. 18

42

Technical Guidelines on the Research on Oral Solid Dosage Drugs' Blend Uniformity and Uniformity of Central Metered Dosage Units (Consultation Draft)

CDE

Sept. 26

43

Technical Guidelines on Crystal Form Research of Chemical Drugs (Consultation Draft)

CDE

Sept. 26

44

Questions & Answers on Issues Relevant to the "Similarity in Formulation Proportions" in Bioequivalence CMC Criteria in the "Guidelines on Human Bioequivalence Studies for Generic Drugs With Pharmacokinetic Parameters as Final Evaluation Indicators" (Consultation Draft II)

CDE

Sept. 26

45

Guidelines for Designing Clinical Trials for Biosimilars of Teriparatide Injection (Consultation Draft)

CDE

Sept. 30

 If you need more details of the regulations mentioned above, welcome to contact us via contact@chemlinked.com.

Grace Wang
ChemLinked Regulatory Analyst
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