Monthly Recap: China Pharmaceutical Regulatory Updates | August 2021

by Grace Wang Sep 30, 2021

Editor's Note: The 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. NMPA Releases the 44th Batch of Reference Listed Drugs

On Aug. 16, NMPA published the 44th batch of reference listed drugs (RLD). The batch covers 54 drug products, such as N.V. Organon's Testosterone Undecanoate Soft Capsules and Pfizer's Tafamidis Meglumine Soft Capsules.

RLDs are selected by NMPA's generic drug quality and efficacy consistency evaluation expert panel. They are products to which new generic versions are compared to show that they are bioequivalent.

The English version of the 44th batch of RLDs has been uploaded to BaiPharm Database.

2. SAMR to Enforce New Rules for Medical Device and IVD Reagent Registration/Filing

On Aug. 26, China State Administration for Market Regulation (SAMR) promulgated Administrative Measures for Medical Device Registration and Filing and Administrative Measures for IVD Reagent Registration and Filing, both set to take effect on Oct. 1, 2021.

The two regulations specified the requirements for registration application/filing documentation, conditions for exempting clinical evaluation/trials, etc. For more details, please refer to ChemLinked BaiPharm article.

In this September, NMPA released the List of Medical Devices Exempted from Clinical Evaluation and the List of In Vitro Diagnostic Reagents Exempted from Clinical Trials, so that applicants can search in the lists to see if their products are eligible for exemption. For more details, please click here.

3. NMPA Announces Four Rx-to-OTC Switches

In Aug. 2021, NMPA granted four formerly prescription (Rx) drugs over-the-counter (OTC) status. Marketing authorization holders (MAHs) of the drugs 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.

Four Rx-to-OTC Switches Announced by NMPA in Aug. 2021


Drug Name

Strength

OTC Class

1

Radix Codonopsis, Astragalus and Schisandra Chinensis (Turcz.) Baill. Capsule (Pinyin: Shenqi Wuweizi Jiaonang)

0.25g/capsule

Class A

2

Pediatric Seven-Herb-Tea Granules (Pinyin: Xiao'er Qixingcha Keli)

3.5g/pack

Class A

3

Gynaecological Health Capsules (Pinyin: Fukang Jiaonang)

0.4g/capsule

Class A

4

Radix Codonopsis and Astragalus Chewable Tablet (Pinyin: Shenqi Jujue Pian)

3.6g/tablet

Class A

4. NMPA Adds Six Substances to the List of Precursor Chemicals

According to an NMPA announcement on Aug. 25, six substances are added to the Catalog and Classification of Precursor Chemicals, an appendix to the Provisions on the Administration of Precursor Chemicals. From Sept. 20, the six substances' manufacturing, supply, purchase, transport, import and export shall comply with regulations on non-medical precursor chemicals.  

Six Substances Added to the List of Precursor Chemicals


Substance

CAS

Precursor Chemical Class

1

Methyl 3-oxo-2-phenylbutanoate (MAPA)

16648-44-5

Class II

2

3-oxo-2-phenylbutanamide (APAA)

4433-77-6

Class II

3

3-(Benzo[d][1,3]dioxol-5-yl)-2-methyloxirane-2-carboxylic Acid

2167189-50-4

Class II

4

Methyl 3-(1,3-Benzodioxol-5-yl)-2-methyl-2-oxiranecarboxylate

13605-48-6

Class II

5

Phenylacetonitrile

140-29-4

Class III

6

Gamma-Butyrolactone

96-48-0

Class III

5. CDE Consults on Regulations on Post-Approval Changes to Overseas-Manufactured Drugs

On Aug. 30, CDE released Procedures and Requirements for Overseas-Manufactured Drug's Post-Approval Filing Changesfor public opinions.

Procedures for Overseas-Manufactured Drug's Post-Approval Filing Changes in China (draft in consultation)

1. The applicant submits electronic documents to file an application at NMPA's system, then the applicant will get a filing number after the system receives all the documents.

2. While submitting electronic documents online, the applicant shall also send a collection of paper documents to CDE.

3. NMPA makes the filing information public within five days after the applicant completes the filing.

4. CDE completes reviewing the on-file documents within 60 days after the filing task enters CDE's system.

5. CDE shall check the previous filing information of the drug product when reviewing the relevant supplemental/re-registration applications.

6. Guidelines Released by NMPA and CDE

In Aug. 2021, NMPA and CDE released a total of 27 drug/device guidelines.

Guidelines Released by NMPA and CDE in Aug. 2021


Guideline

Authority

Release Date

1

Naming Guidelines for the Generic Names of Neurological and Cardiovascular Operations Devices

NMPA

Aug. 25

2

Naming Guidelines for the Generic Names of Medical Diagnosis & Examination and Custodial Care Devices

NMPA

Aug. 25

3

Guidelines for Evaluating the Safety and Efficacy of Medical Devices Containing Nanomaterials: System and Framework (Part 1)

NMPA

Aug. 26

4

Technical Guidelines for Expansion Cohort Studies on Antineoplastic Drugs in First-in-Human Trials (Consultation Draft)

CDE

Aug. 03

5

Technical Guidelines for Clinical Trials for Therapeutic Drugs for Acute Nonvariceal Upper Gastrointestinal Bleeding

CDE

Aug. 05

6

Guidelines for Research on Immunogenicity of Low-molecular-weight Generic Heparin Drugs (Trial)

CDE

Aug. 06

7

Technical Guidelines for CMC Research and Evaluation of Human Stem Cell Products (Consultation Draft)

CDE

Aug. 17

8

Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-COVID-19 Chemical Drugs (Trial)

CDE

Aug. 17

9

Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-inflammatory Drugs for COVID-19 (Trial)

CDE

Aug. 17

10

Technical Guidelines for Non-clinical Research on Neutralizing Antibody Drugs for COVID-19 (Trial)

CDE

Aug. 17

11

Technical Guidelines for Clinical Trials for Generic Orally Inhaled Products Only Sold Outside China (Consultation Draft)

CDE

Aug. 17

12

Technical Guidelines for CMC Research and Evaluation of Insulin Products (Consultation Draft)

CDE

Aug. 17

13

Technical Guidelines for Clinical Trials for New Monoclonal Antibody Drugs for Rabies Virus

CDE

Aug. 17

14

Technical Guidelines for Clinical Trials for Therapeutic Drugs for Pulmonary Arterial Hypertension (Consultation Draft)

CDE

Aug. 18

15

Technical Guidelines for Clinical Trials for Therapeutic Drugs for Pediatric Pulmonary Arterial Hypertension (Consultation Draft)

CDE

Aug. 18

16

Designing Guidelines for Clinical Trials for Prophylactic Drugs for Antineoplastic-drug-induced Nausea and Vomiting

CDE

Aug. 18

17

Guidelines for the Data Collection of Adverse Reaction on the Labels of Antineoplastic Drugs

CDE

Aug. 18

18

Technical Guidelines for Clinical Pharmacokinetic Research on New Improved Modified-released Drug Products (Consultation Draft)

CDE

Aug. 24

19

Technical Guidelines for Food-Effect Studies During New Drug Development (Consultation Draft)

CDE

Aug. 24

20

Technical Guidelines for Human Bioavailability and Bioequivalence Studies on Innovative Drugs (Consultation Draft)

CDE

Aug. 25

21

Technical Guidelines for Research on Quality Control of Nanomedicines (Trial)

CDE

Aug. 27

22

Technical Guidelines for Non-clinical Pharmacokinetic Research on Nanomedicines (Trial)

CDE

Aug. 27

23

Technical Guidelines for Research on Non-clinical Safety Evaluation of Nanomedicines (Trial)

CDE

Aug. 27

24

Technical Guidelines for Research on Samples Used in Toxicology Studies for New Traditional Chinese Medicines (Consultation Draft)

CDE

Aug. 30

25

Technical Guidelines for Research on Non-clinical Dependence of Drugs

CDE

Aug. 30

26

Technical Guidelines for Clinical Pharmacological Research on Innovative Drugs (Consultation Draft)

CDE

Aug. 30

27

Technical Guidelines for CMC Research on Compound Traditional Chinese Medicines Managed as Classic Ancient Prescriptions (Trial)

CDE

Aug. 31

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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