-
NMPA Announcement on Matters Concerning the Importation of Pre-approval Commercial-Scale Batch Products of Overseas-Marketed Drugs (No. 96, 2025)
2025-11-28
To implement the relevant requirements of the Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), and to support the early use of innovative and clinically urgently needed drugs for the benefit of patients, the relevant matters related to the importation of pre-approval commercial-scale batches of overseas-marketed drugs are hereby announced as follows.
-
Policy Interpretation of the NMPA Announcement on Matters Concerning the Importation of Pre-Approval Commercial-Scale Batch Products of Overseas-Marketed Drugs
2025-11-28
The NMPA has conducted research to refine the relevant requirements and specific measures, and has issued the Announcement on Matters Concerning the Importation of Pre-Approval Commercial-Scale Batch Products of Overseas-Marketed Drugs (hereinafter referred to as the "Announcement"). This aims to shorten the time gap between drug approval and market supply in China, support the early use of innovative and clinically urgently needed drugs for the benefit of patients, and enhance the health and well-being of patients.
-
NMPA Notice on Issuing the Guidelines for On-Site Inspection of the Quality Management Specifications for Online Sales of Medical Devices NMPA Medical Device Supervision [2025] No. 14
2025-11-28
The National Medical Products Administration (NMPA) has organized the formulation of the Guidelines for On-Site Inspection of the Quality Management Specifications for Online Sales of Medical Devices (hereinafter referred to as the "Guidelines").
-
NMPA Notice on Conducting a Pilot Program for Electronic Labeling of Cosmetics GYJZ [2025] No.16
2025-11-28
The National Medical Products Administration (NMPA) has decided to carry out a pilot program for cosmetic electronic labeling in accordance with the Regulations on Supervision and Administration of Cosmetics (hereinafter referred to as the "Regulations"). The relevant matters are hereby notified as follows.
-
Announcement of the NMPA on the Release of the Good Manufacturing Practice for Medical Devices ([2025] No. 107)
2025-11-07
The National Medical Products Administration has revised the Good Manufacturing Practice for Medical Devices. It is hereby released and shall come into force as of November 1, 2026.
-
NMPA Announcement on Optimizing of the Review and Approval Process for Clinical Trials of Innovative Drugs ([2025] No. 86)
2025-10-14
China's top legislator Zhao Leji on Wednesday met with Liberian Senate President Pro Tempore Nyonblee Karnga-Lawrence, who is in Beijing for the Global Leaders' Meeting on Women.