In June 2021, The Pharmacy and Poisons Board of Hong Kong issued 5 new guidances for Advanced Therapy Products. These guidances will be effective in August 2021.
Guidance on Classification of Advanced Therapy Products
The aim of this document
Regulatory News
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 Ministers of the 10 ASEAN Member States.
ACCSQ Pharmaceutical
HSA Singapore issues new guidance on Consent Requirements for Clinical Trials Involving Collection and Use of Human Tissue
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
Access Consortium Releases Strategic Plan for 2021 – 2024
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
Singapore HSA Publishes Regulatory Guideline for 3D-Printed Medical Devices
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
ASEAN Revises the ASEAN Variation Guidelines and Issued The Q&A on ASEAN Stability Guidelines
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
Hong Kong DOH Updates List of Recognised Standards for Medical Devices
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
Hong Kong DOH Updates Guidances for Listing of General Medical Devices and IVDs
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
Hong Kong DOH Revised Submission Timeframes for Medical Device Adverse Event Reports
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