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Regulatory News
State Council Issues New Document to Reform Licensing Mechanisms 10/11/2018
CDE Solicits Comments on Technical Requirements for Manufacturing... 10/8/2018
NMPA Issues Rules for Communications Related to Drug R&D and Tech... 10/8/2018
NMPA Issues Announcement Regarding Direct ADR Reporting by MAHs 9/30/2018
NMPA Restores Import of Cubist Pharma’s Cubicin after Re-inpsect... 9/26/2018
CDE Seeks Comments on Draft Chinese Translations of ICH Guideline... 9/26/2018
CDE Issues Notice to “Enhance” GQCE Evaluation of 289 Essential... 9/25/2018
CPA Releases Announcement for Excessively-Supplied Drug Products ... 9/21/2018
CDE Solicits Comments on Core Considerations for Clinical Protoco... 9/20/2018
CDE Seeks Comments on Draft Chinese Translations of Seven ICH Gui... 9/20/2018
NMPA Releases List of Reference Formulations for Generic Drug Equ... 9/13/2018
NMPA's Official Responsibilities and Internal Organization Approv... 9/11/2018
SAMR's Official Responsibilities and Internal Organization Approv... 9/11/2018
CDE Publicizes Batch 32 of Drug Applications To Be Granted Priori... 9/11/2018
NMPA Issues New Announcement (2018#64) for Clinical Data Self-Ins... 9/10/2018
NMPA Suspends Sales and Use of Dr. Reddy’s Quetiaping Fumarate F... 9/7/2018
NMPA Solicits Comments on Draft Guidelines on Collection and Repo... 9/7/2018
NMPA Withdraws Approvals of Six Drugs Including Four Import Drugs... 9/7/2018
CDE Seeks Comments on Draft ICH Guideline M9: Guideline on BCS-Ba... 9/5/2018
CDE issues General Requirements for Batch Sample Size of BE Studi... 8/30/2018
Final Government Reorganization Plan Unveils Regulatory Roles of ... 8/30/2018
New English Name of China's Drug Watchdog Confirmed to be NMPA 8/30/2018
CNDA Solicits Comments on Draft Document for Infrastructural Buil... 8/24/2018
Chinese Government Issues Notice for Correction of Pharma and Med... 8/23/2018
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