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,
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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
read more...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
read more...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
read more...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
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