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Regulatory News
 
NMPA Issues Guidelines for Clinical Trials of Mental and Bipolar ... 11/8/2018
NMPA Issues New Announcement (2018#86) for Clinical Data Self-Ins... 11/8/2018
Shanghai Promotes Biopharma Innovation with New Measures 11/7/2018
CDE Issues Notice Over Change of Priority Review Publication Proc... 11/7/2018
NMPA Releases List of Reference Formulations for Generic Drug Equ... 11/6/2018
NMPA Launches New Official Website 11/5/2018
NPC Solicits Comments on Drug Administration Law and Essential He... 11/2/2018
NMPA Issues Guidance Document for Drug IT Tracing System Building... 11/2/2018
CDE Seeks Comments on Draft ICH Guideline S11: Nonclinical Safety... 11/2/2018
CDE Issues List of Foreign New Drugs in Urgent Clinical Need (Bat... 11/1/2018
NMPA and NHC Release New Rule for Evaluation of Urgently Needed F... 10/31/2018
NMPA Issues Two Bioequivalence Study Guidelines 10/30/2018
CDE Solicits Comments on Technical Requirements for Evaluation of... 10/24/2018
Draft Amendment of the Drug Administration Law under Review by th... 10/24/2018
CDE Publicizes Batch 33 of Drug Applications To Be Granted Priori... 10/17/2018
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 ... 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
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