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Provisions for Drug Registration (Abolished)
2019-07-25
The Provisions are formulated for the purposes of ensuring the safety, efficacy and quality of drugs and regulating drug registration in accordance with the Drug Administration Law of the People's Republic of China, Administrative Permission Law of the People's Republic of China and the Regulations for Implementation of the Drug Administration Law of the People's Republic of China.
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Provisions for Drug Insert Sheets and Labels
2019-07-25
The Provisions for Drug Insert Sheets and Labels, adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, is hereby promulgated and shall go into effect as of June 1, 2006.
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Good Manufacturing Practice for Drugs (2010 Revision)
2019-07-25
The Good Manufacturing Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry of Health on October 19, 2010, is hereby promulgated and shall go into effect as of March 1, 2011.
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NMPA Issued the Announcement on the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings
2019-07-18
NMPA organized the formulation of the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings (Chemicals) and the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings (Biologicals), which were issued on June 25, 2019.
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NMPA issued the Announcement on Implementing Electronic Application of Medical Device Registration
2019-07-06
NMPA has organized the development of the electronic Regulated Product Submission (eRPS) system, and announced the relevant issues on May 31, 2019
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NMPA Issued the Announcement on Issues Concerning the Import of Reference Drugs for Clinical Research of Biosimilar Drugs
2019-07-06
On November 30, 2018, NMPA issued the Announcement on Issues Pertaining to the One-off Import of Reference Drugs for Biologicals in Clinical Trials (Announcement No. 94 of 2018).