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.
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.1 Find out the detailed classifications at 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, 2023.2 Learn about relevant requirements at BaiPharm's report.
3. China NMPA Consults on Chemical API Registration Renewal Regulation
On Nov. 4, NMPA released the draft of 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.3
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. Find out detailed timing requirements at BaiPharm's report.
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.4 The list took effect on Dec. 1, 2022, the same day when the Administrative Measures for Supervising Online Sales of Drugs came into force. More details at BaiPharm's report.
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:
The platform's company name
Legal representative person;
Unified social credit code;
Website name;
Domain name, etc.5
Online drug sellers shall report the following information to local medical products administrations:
The seller's company name;
Website name;
Application (App) name;
IP address;
Domain name;
Drug manufacturing license or drug supplying license, etc.
Read about details at BaiPharm’s report.
6. China NMPA to Enforce Drug Retail Delivery Regulations
On Nov. 30, NMPA released the Sixth Appendix to Good Supply Practices (GSP) for Pharmaceuticals: Quality Management for Drug Retail Delivery. The Appendix applies to the delivery after drug retail transactions, including online transactions.
Delivery covers selecting, verifying, packing, sealing, sending, and transporting the drug needed by the customer to the required place until the sign after receipt.
The Appendix requires drug retailers to take effective quality management measures and ensure the drug information is traceable during delivery.6 Find out details at BaiPharm's report.
7. China NMPA Consults on Drug MAH's Main Responsibilities
On Nov. 29, NMPA released the draft of Administrative Rules on Supervising Drug Marketing Authorization Holders on Carrying Out Main Responsibilities. The Rules specifies MAH's obligations including arranging qualified persons responsible for manufacturing, quality control, and pharmacovigilance, as well as ensuring GMP-compliant storage and the traceability of drugs, etc.7 Find more about MAH system in China at BaiPharm's insight.
8. China CDE Implements Work Procedures for Changes During Drug Review
On Nov. 11, China CDE issued the Work Procedures for Changes During the Review of Drug Registration Application (Trial) with immediate effect. The Work Procedures stipulates that during the review of marketing authorization application, the applicant should withdraw the application if major change impacting safety, efficacy, and/or quality controllability is made, and resubmit after additional researches.8
9. China CDE Implements Rules on Timekeeping for Drug Review
On Nov. 16, CDE released the Administrative Rules on Stopping and Resuming the Time Clock for Drug Review. The clock stops due to situations like CDE asking the applicant to submit supplemental documents, and other necessary scenarios. The clock will continue when the required documents are submitted to CDE.9
10. China Pushes Forward the Real World Study on Drugs in Hainan
On Nov. 18, the Provisions for Real World Study on Drugs came into effect. According to the Provisions, if one drug is in urgent need and approved to be only imported to Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, the applicant can apply for China's national marketing authorization by using the real world data in the zone.10 Learn more at BaiPharm's insight.
11. CDE Issues Guidelines
In November 2022, CDE issued 19 guidelines:
12. Chinese Pharmacopoeia Commission Releases Drafts of Drug Standards
Chinese Pharmacopoeia Commission issued the following drafts of drug standards for comments.
No. | Draft of Standards | Type | Issuance |
1 | Standard of excipient standard | Nov. 4 | |
2 | Determination method | Nov. 8 | |
3 | Determination method | Nov. 8 | |
4 | Guidelines on Biological Evaluations and Trial Selection of Pharmaceutical Packaging Materials | Guideline | Nov. 21 |
5 | Guidelines on Validation of Alternatives of Microbial Testing for Drugs | Guideline | Nov. 29 |
6 | Standard of active pharmaceutical ingredient (API) | Nov. 29 | |
7 | Standard of API | Nov. 29 | |
8 | Testing method | Nov. 29 | |
9 | Guideline | Nov. 29 |
Please contact us if you need more details of the summarized contents above.
Read More
Monthly Recap: China Pharmaceutical Regulatory Updates | October 2022
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2022
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2022
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