-
NMPA Announcement on the Applicability of ICH Guideline E11A: Pediatric Extrapolation (No. 139, 2024)
2025-02-19
To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply ICH Guideline E11A: Pediatric Extrapolation (hereinafter referred to as the E11A Guidelines).
-
NMPA Announcement on the Applicability of ICH Guideline M12: Drug Interaction Studies and Its Q&A Document (No. 130, 2024)
2025-02-19
To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply ICH Guideline M12: Drug Interaction Studies and its Q&A document (hereinafter referred to as the M12 Guidelines and its Q&A document).
-
NMPA Announcement on Issuing the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders
2025-02-19
To implement the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, and to strengthen the management of overseas marketing authorization holders (MAHs), the National Medical Products Administration (NMPA) has formulated the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders. These provisions are hereby issued and will come into effect from July 1, 2025.
-
NMPA Notice on Printing and Issuing the Guidelines for On-Site Inspection of the Good Supply Practice for Medical Devices
2025-02-19
The revised Good Supply Practice for Medical Devices (hereinafter referred to as the Regulations) will be implemented as of July 1, 2024. To standardize and instruct the on-site inspection of the Good Supply Practice for Medical Devices, the National Medical Products Administration (NMPA) has formulated the Guidelines for On-site Inspection of Good Supply Practice for Medical Devices (hereafter referred to as the Guidelines), which is hereby printed and issued.
-
Provisions for Medical Device Registration and Filing
2024-06-05
Promulgated by SAMR Decree No. 47, issued on August 26, 2021 and shall go into effect as of October 1, 2021
-
Provisions for In-vitro Diagnostic Reagent Registration and Filing
2024-06-05
Promulgated by SAMR Decree No. 48, issued on August 26, 2021 and shall go into effect as of October 1, 2021