On June 12, 2023, the Minister of Finance issued Circular 41/2023/TT-BTC on the rate, collection, payment, management and use in the field of pharmaceuticals and cosmetics.
This Circular is effective on
Regulatory News
Singapore HSA Announces Phase 2 of Voluntary Notification of Health Supplements and Traditional Medicines
Singapore Health Sciences Authority (HSA) had implemented the first phase voluntary notification initiative for Health Supplements and Traditional Medicines on 1st August 2022.
Previous related article can be found at the
Singapore HSA Updates Therapeutic Product Registration Guidelines
As part of Singapore HSA’s ongoing initiatives to improve regulatory efficiency and enhance clarity in HSA’s regulatory requirements and processes, the Therapeutic Products Branch (TPB), Health Products Regulation Group of
Singapore HSA Revises Guideline on Consignment Importation of Therapeutic Product
Singapore HSA revised Guideline on Import a Therapeutic Product on Consignment Basis. The revised guideline provides further clarity to the condition for approval and documentary requirement to apply for importation
Malaysia MDA Update on Transition Period for the Use of Electronic Medical Device Registration Certificate
Malaysia MDA released an update on the use of Electronic Medical Device Registration Certificate starting 2 May 2023. Establishment can download the Medical Device Registration Certificate from MeDC@St2.0+ system once
Singapore HSA Updates Guidance on Unregistered Therapeutic Product Import and Supply
In March 2023, HSA updated Guidance on Import and Supply of An Unregistered Therapeutic Product For Patients’ Use.
See Pharma To Market insider: https://www.pharmatomarket.com/singapore-hsa-updates-unregistered-therapeutic-product-import-and-supply-guidance-and-forms/?utm_source=rss&utm_medium=rss&utm_campaign=singapore-hsa-updates-unregistered-therapeutic-product-import-and-supply-guidance-and-forms
Minor revision was made by HSA to the
Malaysia MDA Issued Guideline on Notification of Custom-Made Medical Device
Malaysia MDA issued the first edition guideline on Notification of Custom-Made Medical Device (MDA/GD/0064) on 28 February 2023.
This guidance document specifies requirements and notification process for the applicant to obtain
Singapore HSA Updates Unregistered Therapeutic Product Import and Supply Guidance and Forms
Singapore HSA Updates Guidance TPB-GN-004-005 regarding the Import and Supply of an Unregistered Therapeutic Product For Patients’ Use.
HSA includes the conditions for using the “named-patient” special access route as following:
a)
Singapore HSA Enhances Medical Device Change Notification Process
Singapore HSA has enhanced the Change Notification application process for Medical Device online platform (MEDICS) that will come into effect from 7 March 2023.
HSA’s Medical Device guidance GN-21: Guidance on