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;
Center for Food and Drug Inspection (CFDI), 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 January 2025.
1. China Releases Several Lists of Reference Listed Drugs (RLDs)
In January, China published the following updates to the Reference Listed Drugs (RLDs) lists:
For the complete RLDs List, please refer to the BaiPharm Database.
2. China NMPA Grants Two Rx-to-OTC Switches
In January, NMPA granted over-the-counter (OTC) status to two previous prescription drugs: Jieyu Mind-tranquilizing Granules and Jieyu Mind-tranquilizing Capsules.
For the complete OTC catalog, please refer to the BaiPharm Database.
3. China Issues Appendices to GMP for Pharmaceutical Excipients and Packaging Materials
On January 2, 2025, China's National Medical Products Administration (NMPA) released two appendices to the Good Manufacturing Practice for Pharmaceutical Products (2010 Revision), specifically targeting pharmaceutical excipients and packaging materials respectively. These appendices will come into effect on January 1, 2026. Before this date, manufacturers of pharmaceutical excipients and packaging materials must upgrade their facilities and enhance their quality management systems to fully comply with the new requirements.
4. China Introduces Revised Medical Devices Supervision and Administration Regulations
On January 7, 2025, China's National Medical Products Administration (NMPA) officially released the Medical Devices Supervision and Administration Regulations (2025 version), replacing the 2017 version. Compared with the 2017 version, the 2025 version encompasses revisions in the general principles, registration and filing, production requirements, operation and use, adverse events monitoring and recalls, supervision and inspection, and legal responsibilities.
5. China Standardizes the Import Management Process at Mengkang and Mohan Ports for Medicinal Materials
China's State Council has authorized Mengkang Port and Mohan Port (including Mohan Railway Port) as newly designated border points for importing medicinal materials. On January 14, the General Administration of Customs of China released several detailed measures. Specific customs codes are assigned to the ports: 8631 for Mengkang Port, 8612 for Mohan Road Port, and 8649 for Mohan Railway Port. The Pu'er and Kunming Administrations for Market Regulation will oversee the filing of imported medicinal materials at these ports, utilizing the "drug filing special seal." Both administrations will collaborate with the Yunnan Provincial Food and Drug Supervision and Inspection Research Institute to standardize the filing and inspection procedures. The Yunnan Provincial Drug Administration will also enhance regulatory oversight, improving information systems for registration and port inspections.
6. China Expands Scope of eCTD Implementation for Drug Applications
On January 23, China's NMPA announced the expansion of the scope for the implementation of the electronic Common Technical Document (eCTD) for drug applications. Starting from January 27, 2025, the expanded eCTD implementation will include clinical trial applications for chemical drugs (Class 1 to Class 5), marketing authorization applications for chemical drugs (Class 2, 3, 4, 5.2), as well as clinical trial applications for preventive and therapeutic biological products (Class 1 to Class 3) and marketing authorization applications for preventive and therapeutic biological products (Class 2 and 3).
Applicants submitting via eCTD are required to prepare and submit their electronic application materials according to the current eCTD technical document requirements. The NMPA encourages the use of online submission methods for eCTD materials. Detailed instructions can be found on the NMPA’s drug review center website, along with the notice on trial implementation for submitting drug registration electronic materials via the Internet.
7. China Seeks Information on Low-Volume Drugs in National Reimbursement Drug List (NRDL)
On January 24, China’s National Healthcare Security Administration (NHSA) announced a call for information on drugs with low transaction volumes within the National Reimbursement Drug List (NRDL). Pharmaceutical marketing authorization holders (MAH) are requested to provide detailed information about the drugs listed in the low-volume drugs list (first batch) by February 28, 2025. Companies must submit a commitment letter, basic drug information sheet, and necessary supporting documents, including the latest drug approval documents, clinical value analysis, production and supply status, and any plans for resumption of production if applicable. This information will assist in ensuring continued medication availability for insured patients and guide future revisions to the NRDL.
8. China Authorizes One Drug for Inclusion in the CARE Plan
China CDE launched the "patient-Centered Action for Rare diseases Encouragement" (CARE Plan) in September. Drug developer can submit applications to join the CARE Plan through the CDE’s communication channels. In January, one drug received approval to be included in the CARE Plan:
ALXN2350 Injection from AstraZeneca Global R&D (China) Co., Ltd.
9. China Releases Pharmaceutical Guidelines
In January 2025, China unveiled the following guidelines on chemical drugs and biological products.
10. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
In January 2025, the Chinese Pharmacopoeia Commission released 18 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods. Details are as below:
Excerpt of the 18 draft standards
No. | Draft standard | Type | Consultation Period (YYYY-MM-DD) |
1 | Monograph-excipient | 2025-01-02 ~ 2025-04-02 | |
2 | Monograph-excipient | 2025-01-02 ~ 2025-04-02 | |
3 | Cefotiam Hydrochloride for Injection | Monograph-chemical drug | 2025-01-02 ~ 2025-02-01 |
4 | Cefotiam Hydrochloride | Monograph-chemical drug | 2025-01-02 ~ 2025-02-01 |
5 | Salbutamol Sulfate Inhalation Aerosol | Monograph-chemical drug | 2025-01-03 ~ 2025-02-02 |
Contact BaiPharm if you are interested in learning more about the draft standards or other drug registration regulations in China.
