The Taiwan FDA issues on 16 July 2020 the guidance on in-vitro companion diagnostic devices (CDx), which are aimed to provide a reference on device efficacy and safety for manufacturers
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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 has published interim regulatory decisions pertaining to drug conditional and
read more...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) inspections for non pharmaceutical category (health supplements, traditional medicines and
read more...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 Standards (Pilot)” (No. 5 in 2020). The guidance document which
read more...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 Update Report” (No. 7 of 2020).
The rules were established to
read more...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. 46 of 2020). The specification is to meant to provide
read more...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 selected listed medicines that use traditional indications in the second
read more...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 Requirements for submission:-
a) 化学药品注册分类及申报资料要求 Classification System for Registration of Chemical
read more...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 Products PE009-14 (PIC/S Guide to GMP), excluding Annexes 4, 5
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