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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.
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Rules for Classification of Medical Devices
2019-10-11
The Rules for Classification of Medical Devices, adopted at the executive meeting of China Food and Drug Administration on June 3, 2015, is hereby promulgated and shall be effective as of January 1, 2016.
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Provisions for Instructions and Labels of Medical Devices (Decree No.6 of China Food and Drug Administration)
2019-10-11
The Provisions for Instructions and Labels of Medical Devices, adopted at the executive meeting of China Food and Drug Administration on June 27, 2014, is hereby promulgated and shall be effective as of October 1, 2014.
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Provisions for Drug Recall (SFDA Decree No. 29) (Abolished)
2019-10-11
The Provisions for Drug Recall was deliberated and adopted by the executive meeting of the State Food and Drug Administration on December 6, 2007 and now is issued. These Provisions shall go into effect as of the date of promulgation.