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Announcement by the National Medical Products Administration on Issuing the Implementation Measures for the Drug Regulatory Data Protection (No. 47, 2026)
2026-10-27
To promote drug innovation and improve the system for the drug regulatory data protection, the National Medical Products Administration (NMPA) has, in accordance with the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and other relevant provisions, and by drawing on international experience, formulated the Implementation Measures for Drug Regulatory Data Protection (hereinafter referred to as "the Implementation Measures").
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Implementation Measures for Drug Regulatory Data Protection
2026-10-27
These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Implementing Regulations of the Drug Administration Law of the People's Republic of China, the Provisions for Drug Registration, and other relevant laws and regulations, for the purpose of encouraging drug innovation and meeting the public's needs for drugs.
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Policy Interpretation of the Implementation Measures for Drug Regulatory Data Protection
2026-10-27
The core of drug regulatory data protection lies in protecting original regulatory data generated to demonstrate the safety and efficacy. Therefore, new data protection can only be granted if new data demonstrating the safety and efficacy of the drug is generated.
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Announcement of the National Medical Products Administration on Matters Concerning Further Optimizing Review and Approval of Overseas-Marketed Drugs in Clinical Urgent Need (No. 3, 2026)
2026-10-27
In order to accelerate the marketing of overseas-marketed drugs in China in clinical urgent need and meet patients’ urgent clinical medication needs, the National Medical Products Administration (NMPA) decided to further optimize the working mechanism for review and approval of overseas-marketed drugs in clinical urgent need.
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Policy Interpretation of the Announcement of the National Medical Products Administration on Matters Concerning Further Optimizing Review and Approval of Overseas-marketed Drugs in Clinical Urgent Need
2026-10-27
In order to further encourage more overseas-marketed drugs in clinical urgent need to enter the Chinese market and benefit domestic patients, NMPA has researched and drafted the Announcement of NMPA on Matters Concerning Further Optimizing Review and Approval of Overseas-marketed Drugs in Clinical Urgent Need (hereinafter referred to as the Announcement).
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Announcement of the National Medical Products Administration on the Implementation of Unique Device Identification for Medical Devices in Specific Circumstances (No. 15, 2026)
2026-10-27
To further implement the Regulations for the Supervision and Administration of Medical Devices, 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, and the key tasks of the State Council concerning the deepening of the reform of the medical and health system, and to better guide the implementation of the Unique Device Identification (UDI) system for medical devices, the relevant matters concerning the implementation of UDI for medical devices in specific circumstances are hereby announced as follows.