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
Regulatory News
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
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
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
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
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
Japan Release Document on Clinical Evaluation of Pediatric Population along with Adults
03 June 2020, The Ministry of Health, Labour and Welfare (MHLW) of Japan released a document providing general guidelines for the clinical evaluation of children that can also be evaluated
Malaysia Publishes Guidance Document for Medical Device Distribution Records
On June 2020, Medical Device Authority (MDA) of Malaysia has published a guidance document to set a framework for the management of medical device distribution records.
The guidance document is created
Taiwan to Conduct GCP Inspection in Compliance with New Drug Applications
Taiwan Food and Drug Administration (FDA) published a guideline on 28 May 2020 to improve the efficiency of new drug reviews and strengthen the link between Good Clinical Practice (hereinafter