Australia TGA Releases Guidance on Exemption for Clinical Decision Support Software
The Therapeutic Goods Administration (TGA) Australia has released a guidance document on Exempt Clinical Decision Support Software (CDSS) for sponsors, …
Singapore HSA Releases Information on Import and Supply of Unregistered Medical Devices
The Health Sciences Authority (HSA) Singapore has provided some guidance on the import and supply of unregistered medical devices by …
Singapore HSA Releases Guidelines on Claims and Claims Substantiation of Health Supplements and Traditional Medicines
The Health Sciences Authority (HSA) Singapore has released guidelines on claims and claims substantiation for Health Supplements (HS) and Traditional …
NPRA Malaysia Announces Implementation of Pilot Project for Pharmaceutical Track and Trace for Vaccines
The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has announced their plan to develop a Pharmaceutical Track & Trace system that …
Singapore HSA Releases Guideline on Voluntary Notification System for Health Supplements and Traditional Medicines
The Health Sciences Authority (HSA) Singapore has released a new guideline to outline the process involved for voluntary notification of …
Hong Kong Drug Office Publishes Frequently Asked Questions on Bioavailability and Bioequivalence Studies for Pharmaceutical Drugs
Hong Kong Drug Office has published a set of frequently asked questions on Phase 2 requirements of bioavailability (BA) and …
NPRA Malaysia Updates Variation Guideline for Pharmaceutical Products
The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has published the second edition of the variation guideline for pharmaceutical products in …
Singapore HSA Publishes Guideline on Testing Requirements of Health Supplements and Traditional Medicines
The Health Sciences Authority (HSA) Singapore has published the latest version of the guideline on testing requirements for health supplements …
Philippines FDA Publishes Circular on Labelling Requirements of Drug Products under Maximum Retail Price
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2022-005, which provides some information on the process …