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NMPA issued the Announcement on the Annual Report for National ADR Monitoring (2018)
2019-10-18
On October 18, 2019, NMPA issued the Announcement on the Annual Report for National ADR Monitoring (2018).
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NMPA Issued Guidelines for Technical Review of the Registration of Custom-Made and Material AdditiveBased Medical Devices of Passive Implantable Bones, Joints and Oral Hard Tissues
2019-10-15
NMPA has organized the formulation of and released on May 15, 2019 the Guidelines for Technical Review of the Registration of CustomMade and Material Additive-Based Medical Devices of Passive Implantable Bones, Joints and Oral Hard Tissues.
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NMPA Issued the Announcement on Effective Implementation of Unique Identification for the First Batch of Medical Devices
2019-10-15
On October 14, 2019, NMPA issued the Announcement on Effective Implementation of Unique Identification for the First Batch of Medical Devices (hereinafter referred to as the Announcement), which clearly defines the scope, schedule and work requirements of unique identification for the first batch of medical devices.
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NMPA Issued the Technical Guidelines for Endpoints in Clinical Trials for Advanced Non-Small Cell Lung Cancer
2019-09-18
NMPA has organized the formulation of and released on September 18, 2019 the Technical Guidelines for Endpoints in Clinical Trials for Advanced Non-Small Cell Lung Cancer.
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NMPA Issued the Announcement on Registration Application Situation and Self-Examination & Verification of Drug Clinical Trial Data
2019-10-15
On October 15, 2019, NMPA released the Announcement on Registration Application Situation and Self-Examination & Verification of Drug Clinical Trial Data with decision made to verify the clinical trial data of 7 newly received registration applications for drugs that have completed the clinical trials and are applying for production.
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Provisions for Unannounced Inspection of Drugs and Medical Devices (Decree No.14 of China Food and Drug
2019-10-11
The Provisions for Unannounced Inspection of Drugs and Medical Devices, adopted at the Executive Meeting of China Food and Drug Administration on May 18, 2015, is hereby promulgated and shall be effective as of September 1, 2015.
