Editor's Notes: Monthly recap is a collection of China's laws, regulations, standards, and policies on chemical drugs and biological products. Generally, the regulatory updates are from these authorities:
National Medical Products Administration (NMPA);
Center for Drug Evaluation (CDE), NMPA;
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 October 2024.
1. China Releases Several Lists of Reference Listed Drugs (RLDs)
In October, China published the following updates to the Reference Listed Drugs (RLDs) lists:
For the complete RLD List, please refer to the BaiPharm Database.
2. China Publishes Re-registration Requirements for Domestically Manufactured Drugs
On October 11, 2024, China's National Medical Products Administration (NMPA) published the Application Procedures and Documentation Requirements for the Re-registration of Domestically Produced Drugs, effective since January 1, 2025. Domestic drug market authorization holders and chemical API registrants shall submit their re-registration applications online through the NMPA’s online service platform (https://zwfw.nmpa.gov.cn) in compliance with the new requirements between 12 months and 6 months prior to the expiration of the validity period of their drug approval certificates, including drug registration certificate, chemical active pharmaceutical ingredients (API)’s approval notice, and drug re-registration approval notice.
3. China Consults on Scope and Procedures for Bioequivalence Test Filings of Chemical Drugs
On October 21, 2021, to streamline the filing process and define the scope of bioequivalence (BE) test, the China CDE released the draft of the Scope and Procedures for Bioequivalence Test Filings of Chemical Drugs for public consultation. The feedback period for the draft is one month, starting from the release date.
4. China CDE Releases Dossier Requirements for the Transfer of Imported Preventive Biological Products to Domestic Production
On October 23, China CDE released the Dossier Requirements for Marketing Authorization Applications of Approved Imported (Preventive Biological Products) Drugs to Be Transferred to Domestic Production. According to the document, such products should be submitted for marketing authorization approval by local applicants based on the requirements for Class 3.3 therapeutic biological products.
5. China Introduces Expedited Acceptance Services for Certain Drugs
Starting on November 1, 2024, the China's CDE, along with its regional branches in the Yangtze River Delta and the Greater Bay Area, starts to offer expedited acceptance services for market authorization applications of innovative drugs and drugs identified through communication as eligible for priority review and conditional approval procedures. Prior to submitting a market authorization application, applicants can request expedited acceptance services for consultation issues related to application acceptance (such as regulations, submission procedures, and supporting documents, but excluding technical review matters).
6. China Releases Pharmaceutical Guidelines
In October 2024, China unveiled the following guidelines on chemical drugs and biological products.
No | Guidelines | Authority | Status | Issued (YYYY-MM-DD) | Enforced Date (YYYY-MM-DD) |
1 | Technical Guideline on Model-Guided Drug Development for Rare Diseases | CDE | Draft | 2024/10/10 | / |
2 | Technical Guideline on SUSAR Analysis and Handling in Clinical Trials of Anti-Cancer Drugs | CDE | In force | 2024/10/10 | 2024/10/10 |
3 | Technical Guideline on Clinical Pharmacological Studies on Rare Disease Drugs | CDE | Draft | 2024/10/12 | / |
4 | CDE | Draft | 2024/10/18 | / | |
5 | CDE | In force | 2024/10/18 | 2024/10/18 | |
6 | Technical Guideline on Evaluation of pH-Dependent Drug Interactions in Oral Medications | CDE | Draft | 2024/10/24 | / |
7 | Technical Guideline on Clinical Studies on Drug Concentration-QTc Prolongation | CDE | Draft | 2024/10/25 | / |
8 | General Principles for Using Real-World Data to Support Active Drug Safety Monitoring | CDR | Draft | 2024/10/25 | / |
9 | Technical Guideline on Clinical Pharmacology Studies on Antibody-Drug Conjugates | CDE | Draft | 2024/10/25 | / |
10 | Technical Requirements for and Common Issues in Replicable Lentivirus Testing | CDE | In force | 2024/10/28 | 2024/10/28 |
7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
In October 2024, the Chinese Pharmacopoeia Commission released 65 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods. Details are as below.
Excerpt of the 65 draft standards
No. | Draft standard | Type | Consultation Period (YYYY-MM-DD) |
1 | Monograph- excipient | 2024/10/21-2024/11/21 | |
2 | Monograph- chemical drug | 2024/10/24-2024/11/24 | |
3 | Monograph- chemical drug | 2024/10/24-2024/11/24 | |
4 | Monograph- chemical drug | 2024/10/25-2024/11/25 | |
5 | Monograph- chemical drug | 2024/10/25-2024/11/25 | |
6 | Monograph- chemical drug | 2024/10/25-2024/11/25 | |
7 | Monograph- TCM | 2024/10/31-2024/12/01 |
Contact BaiPharm if you are interested in learning more about the draft standards or other drug registration regulations in China.
