Taiwan Issues Guidance on In-Vitro Companion Diagnostic Devices (CDx)
The Taiwan FDA issues on 16 July 2020 the guidance on in-vitro companion diagnostic devices (CDx), which are aimed to …
China Releases Working Procedures for Breakthrough Therapy Drugs, Conditional Approval and Priority Review
In order to support the implementation of the new Regulations of Drug Registrations, The National Medical Products Administration(NMPA) of China …
Malaysia Issues Document for GMP Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers
On 01 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia released a guidance document for good manufacturing practice(GMP) …
China’s CDE Issues Guideline for Risk Management of Clinical Trials
Center for Drug Evaluation (CDE) of China published a guideline document pertaining to “Clinical Trial Safety Information Evaluation and Management …
NMPA Issues Rules for Development Safety Update Reports(DSUR)
On 01 July 2020, China’s NMPA’s Center for Drug Evaluation(CDE) has issued administrative rules titled “Management Guidance/Standard for Development Safety …
China Issues Specifications of Creating Periodic Risk Assessment Report for Medical Devices
The National Medical Product Administration (NPRA of China) has published specifications for creating a Periodic Assessment Report for Medical Devices(NO. …
Australia TGA to Review Listed Medicines with Traditional Indications in Second Half of 2020
The Therapeutics Goods Administration (TGA) of Australia on 02 July 2020 has a guidance document announcing a compliance review of …
NMPA Releases Guidance Document for Chemical Drugs/Biological Products
National Medical Products Administration(NMPA) of China releases two guidances on drug registration categories for Chemical Drugs / Biologic Products and …
Australia TGA Issues a Notice on Transition to New GMP Requirements for Medicinal Products
Therapeutic Goods Administration(TGA) of Australia will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal …