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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 Promulgated the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor VIII and the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor IX
2019-07-18
NMPA organized the formulation of the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor VIII and the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor IX, which were issued on June 11, 2019.
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NMPA Promulgated the Guidelines for Clinical Safety Literature Evaluation of Marketed Drugs (Interim)
2019-07-18
NMPA organized the formulation of the Guidelines for Clinical Safety Literature Evaluation of Marketed Drugs (Interim), which was issued on June 18, 2019.
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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.