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 …
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 …
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 …
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 …
Taiwan Intends to Implement Inspection scheme for Bioequivalence Trial ( in 2021)
Towards an aim to ensure the quality and data management of bioequivalence study, the Taiwan Food and Drug Administration ( …
NMPA of China Releases Chinese Pharmacopoeia 2020
Upon the review and approval of the plenary meeting of 11th Pharmacopoeia Commission Executive Committee, China’s National Medical Products Administration …