ACCSQ-PPWG Endorsed 3 Manuals in connection with ASEAN Mutual Recognition Arrangement For Bioequivalence Study Reports Of Generic Medicinal Products
An ASEAN Mutual Recognition Arrangement (MRA) for Bioequivalence (BE) Study Reports of Generic Medicinal Products was signed on 2nd November 2017 in Manila, Philippines by
read more...On 1st July 2021 , Health Sciences Authority (HSA) Singapore issued new guidance on Consent Requirements for Clinical Trials Involving Collection and Use of Human Tissue, which will applies to new clinical trial applications submitted to HSA from 1 August
read more...Access Consortium has released their Strategic Plan 2021-2024 in June 2021 to allow shareholders to learn more about the future the consortium envisions. This plan will guide the consortium towards
read more...On 15th July 2021, HSA has finalised the Regulatory Guideline for 3D-printed medical devices. A separate FAQ has been compiled to further clarify on specific queries highlighted during the consultation
read more...The ASEAN ACCSQ-PPWG has endorsed the following documents.
(i) the ASEAN Variation Guideline (AVG) Rev. 2; endorsed at the 31st PPWG Meeting, and
(ii) Q&A for the Stability Guideline; endorsed intersessionally in August 2020.
The
read more...In May 2021, Hong Kong Department of Health updated the RS-01: List of Recognised Standards for Medical Devices
Medical devices listed under the Medical Device Administrative Control System (MDACS) are required
read more...In April 2021, Hong Kong Department of Health updated the guidances for listing of Class II/III/IV General Medical Devices and Class B, C and D In Vitro Diagnostic Medical Devices into the Medical Device Administrative Control System (MDACS).
GN-02: Guidance Notes for
read more...In April 2021, Hong Kong Department of Health updated the GN-03, Guidance Notes for Adverse Event Reporting by Local Responsible Persons.
Under the MDACS, the Local Responsible Persons (LRPs) are required, among
read more...The guidance dated version 1.0 May 2021, outlines the Good Manufacturing Practice (GMP) compliance requirements for manufacturing biologicals and medicines intended for supply in Australia and TGA’s framework for managing
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