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Announcement of the National Medical Products Administration, the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Disease Control and Prevention Administration on Issuing the Good Clinical Practice (No. 50, 2026)
2026-10-30
To optimize the quality management of drug clinical trials, further foster a standardized and efficient clinical research ecosystem, and support innovation in biopharmaceutical R&D, the National Medical Products Administration (NMPA), together with the National Health Commission (NHC), the National Administration of Traditional Chinese Medicine (NATCM), and the National Disease Control and Prevention Administration (NDCPA), has revised the Good Clinical Practice, which is hereby issued and shall come into force on September 1, 2026.
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Good Clinical Practice for Drugs (2026 Revision): Questions and Answers
2026-10-30
China's GCP serves as a key normative document guiding scientific and compliant drug R&D and regulatory enforcement in line with international standards.
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Work Procedure for the Protection of Drug Regulatory Data
2026-10-30
In order to standardize the drug regulatory data protection (hereinafter referred to as data protection), this Working Procedure is hereby formulated in accordance with the Drug Administration Law of the People's Republic of China, the Regulations for Implementation of the Drug Administration Law of the People's Republic of China, the Provisions for Drug Registration, and the Implementation Measures for Drug Regulatory Data Protection (hereinafter referred to as the Implementation Measures).
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Announcement of the National Medical Products Administration on Issuing the Provisions on the Administration of Registration, Filing and Dossier of New Cosmetic Raw Materials
2026-10-30
To accelerate the research, development and innovation of new cosmetic raw materials and promote the high-quality development of the industry, the National Medical Products Administration (NMPA) has formulated the Provisions on the Administration of Registration, Filing and Dossier of New Cosmetic Raw Materials in accordance with the Regulations on Supervision and Administration of Cosmetics, the Provisions for Registration and Filing of Cosmetics and other relevant provisions.
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Provision on the Administration of Registration, Filing and Dossier Management of New Cosmetic Raw Materials
2026-10-30
This Provision is formulated in accordance with the requirements of the Regulations on Supervision and Administration of Cosmetics and the Measures for the Administration of Cosmetics Registration and Filing, for the purpose of standardizing the administration of registration and filing of new cosmetic ingredients.
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Special Provision on Supervision and Administration of Manufacturing of Traditional Chinese Medicines
2026-10-29
1 In order to promote the inheritance, innovation, and development of traditional Chinese medicine, strengthen the supervision and administration of manufacturing of traditional Chinese medicines (TCMs), regulate production activities for TCMs, and improve the quality of TCMs, the Special Provision on Supervision and Administration of Manufacturing of Traditional Chinese Medicines (hereinafter referred to as the Provision) is established in accordance with the Drug Administration Law of the People's Republic of China, the Law of the People's Republic of China on Traditional Chinese Medicine, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, the Measures for the Administration of Drug Registration, the Measures for the Supervision and Administration of Drug Manufacturing, and other relevant laws, regulations, and rules.