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Announcement of the Center for Food and Drug Inspection of NMPA on Issuing 5 Documents including the Work Procedures for Drug Registration Inspection (Trial) (No. 30 of 2021)
2022-10-11
According to the Provisions for Drug Registration, to clarify the principles, procedures, time limits and requirements of drug registration inspection, to regulate the collaborative between manufacturing site inspection of drug registration and pre-market Good Manufacturing Practice (GMP) inspection, CFDI has organized to formulate the 5 documents
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NMPA Announcement on Issuing the List of Medical Devices Prohibited from Contract Manufacturing
2022-03-24
The National Medical Products Administration organized to revise the List of Medical Devices Prohibited from Contract Manufacturing, which was issued on March 11, 2022 and will take effect on May 1, 2022.
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NMPA Announcement on Issuing the Guidance for the Preparation of Annual Self-inspection Report of Medical Device Quality Management System
2022-03-24
The National Medical Products Administration organized to revise the Guidance for the Preparation of Annual Self-Inspection Report of Medical Device Quality Management System, which are hereby issued, and should take effect on May 1, 2022.
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NMPA Announcement on Issuing the Guidance for Preparation of Contract Production Quality Agreement of Medical Devices
2022-03-24
The National Medical Products Administration organized to revise the Guidance for Preparation of Contract Manufacturing Quality Agreement of Medical Devices, which was issued on March 22, 2022.
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Notice of the National Center for ADR Monitoring Center of NMPA on Issuing the Guidance for the Preparation of Master Files of Pharmacovigilance System
2022-02-25
The National Center for ADR Monitoring has formulated the Guidance for the Preparation of Master Files of Pharmacovigilance System in accordance with the requirements of the National Medical Products Administration, which was issued on February 25, 2022.
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Announcement of the Center for Drug Evaluation of NMPA on Issuing the Technical Guidance for Clinical Trials of New Antiviral Drugs for COVID-19 (Interim)
2022-02-17
In order to guide the scientific research, development and evaluation of antiviral drugs for COVID-19 and provide technical standards for reference, the CDE has formulated the Technical Guidance for Clinical Trials of New Antiviral Drugs for COVID-19 (Interim).
