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 …
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. …
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 …
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 …
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 …
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 …
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 …
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 …
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 …