This 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 customer@reach24h.com.

Contents

1. China NMPA Renews Classifications of Sodium Hyaluronate Products

2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks

3. China NMPA Consults on Chemical API Registration Renewal Regulation

4. China NMPA Announces Drug Banned from Online Sales

5. China NMPA Requires Online Drug Sellers and E-commerce Platforms to File Information

6. China NMPA to Enforce Drug Retail Delivery Regulations

7. China NMPA Consults on Drug MAH’s Main Responsibilities

8. China CDE Implements Work Procedures for Changes During Drug Review

9. China CDE Implements Rules on Timekeeping for Drug Review

10. China Pushes Forward the Real World Study on Drugs in Hainan

11. CDE Issues a Series of Guidelines

12. Chinese Pharmacopoeia Commission Releases Drafts of Drug Standards

1. China NMPA Renews Classifications of Sodium Hyaluronate Products

China issues the new classifications of sodium hyaluronate products on Nov. 14 with immediate effect. Based on intended use and mechanism of action, the products are classified into drugs, medical devices, drug-led combination products, and device-led combination products. Find out the detailed classifications in BaiPharm’s report.

2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks

On Nov. 30, NMPA announced that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted electronically in compact disks with no paper required. The requirement will start on Jan. 1, 2023.

3. China NMPA Consults on Chemical API Registration Renewal Regulation

On Nov. 4, NMPA released the draft of the Announcement on the Administration of Chemical API Registration Renewal for comments. A one-year transition period will be given from the date when the draft takes effect.

After the transition period, all manufacturers of approved APIs shall apply for registration renewal no later than 6 months before the expiration of the approval number/notification.

4. China NMPA Announces Drug Banned from Online Sales

After consulting the draft list in early November, NMPA issued the List of Drug Banned from Online Sales (1st Version), which includes vaccines, blood products, anesthetics, psychiatric drugs, etc. The list took effect on Dec. 1, 2022, the same day when the Administrative Measures for Supervising Online Sales of Drugs came into force.

5. China NMPA Requires Online Drug Sellers and E-commerce Platforms to File Information

On Nov. 30, NMPA required third-party online drug transaction platforms to file records at local provincial-level medical products administrations. The record information includes:

Ÿ   The platform’s company name

Ÿ   Legal representative person;

Ÿ   Unified social credit code;

Ÿ   Website name;

Ÿ   Domain name, etc.

Online drug sellers shall report the following information to local medical products administrations:

Ÿ   The seller’s company name;

Ÿ   Website name;

Ÿ   Application (App) name;

Ÿ   IP address;

Ÿ   Domain name;

Ÿ   Drug manufacturing license or drug supplying license, etc.

6. China NMPA to Enforce Drug Retail Delivery Regulations

[Read more at ChemLinked]

Reference Links