Singapore HSA has published the finalised Guidance on the Medical Device Unique Device Identification (UDI) System on 27 August 2021.
This guidance document is intended to provide clarity on the regulatory requirements for Unique
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Singapore HSA and Malaysia NPRA Launch the HSA-NPRA Generic Medicines Work Sharing Initiative
The Health Sciences Authority (HSA) Singapore and the National Pharmaceutical Regulatory Agency (NPRA) Malaysia have launched the HSA-NPRA Generic Medicines Work Sharing Initiative in August 2021.
This initiative is a work sharing model for the
Australia TGA Publishes Finalised Guidance Document on Regulatory Changes for Software Based Medical Devices
Therapeutic Goods Administration (TGA) Australia has published the finalised guidance document on regulatory changes for software-based medical devices in August 2021.
The guidance provides a summary of changes to the regulation of software-based medical devices (including
Philippines FDA Issues Circular on Guidelines for the Transition Period for Medical Device to the ASEAN Harmonized Technical Requirements
This Circular issued on 9 August 2021 aims to provide guidelines for the transition period of medical devices covered by FC No. 2021-002 may apply for Certificate of Medical Device Notification (CMDN) for the manufacture,
read more...Australia TGA Publishes Updated Document on Prescription Medicines Registration Process
Therapeutic Goods Administration (TGA) Australia published an updated document on the registration process for prescription medicine applications on the 12th of August 2021.
The scope of the document is for applications that need
NPRA Malaysia Issues Updated Guidance Document on Conditional Registration of Pharmaceutical Products During Disaster
National Pharmaceutical Regulatory Agency (NPRA) Malaysia issued an updated guidance document on the requirements of Conditional Registration of Pharmaceutical Products during Disaster, in July 2021.
The main objective of this guidance document is to provide expedited access to pharmaceutical
read more...Hong Kong Drug Office Updates Guidance for Adverse Drug Reaction Reporting Requirements to Add Considerations for Advanced Therapy Products
Hong Kong Drug Office updated Guidance for Adverse Drug Reaction Reporting Requirements to include special considerations for advanced therapy products in section 6, to be effective from 1 August 2021.
Due to their novelty, complexity
read more...Pharmacy and Poisons Board of Hong Kong has issued 5 New Guidances for Advanced Therapy Products
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
read more...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
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