Reclassification of Active Medical Devices for Therapy with a Diagnostic Function. Version 1.0, April 2021: https://www.tga.gov.au/resource/reclassification-active-medical-devices-therapy-diagnostic-function
This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function with meeting their
read more...On 7th May 2021, China’s National Medical Products Administration issued a new Pharmacovigilance Quality Management Practice/Standards (ie. China GvP) to regulate and guide the pharmacovigilance activities of drug marketing authorization
read more...On May 18, 2021, China’s Center for Drug Evaluation of National Medical Products Administration (NMPA) issued the “Notice on the public testing of the patent information registration platform related to the early
read more...The new version Rev. No. 004 , issued on 28 April 2021, clarified on regulatory requirements for clinical trials of controlled drugs or psychotropic substances.
Additional import and export controls under the Health Products (Therapeutic Products)
read more...HSA introduced the Dossier Clarification Supplement in April 2018 for chemical NDA and GDA to facilitate applicants to leverage the approval from a reference agency for the regulatory filing to
read more...HSA, in consultation with industry stakeholders, launched an e-labelling pilot trial for therapeutic products (TP) in August 2019. The objective of e-labelling is to facilitate efficient and timely dissemination of
read more...On 18 February 2021, Thai FDA announced that any GMP clearance approval letter which was approved before the date of this announcement will have their validity extended to April 2022
read more...This guideline specifies the requirements for advertisement of medical devices that require approval and no approval required.
The following materials are controlled through self-regulation, and shall comply with the requirements of
read more...The Philippines FDA, in its commitment to provide stakeholders with streamlined and improved government services, is developing the FDA eServices Portal System – an online platform for FDA marketing authorization
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