The Therapeutic Goods Administration (TGA) Australia has released updates on the regulation of software based medical devices in August 2022.
The guidance was prepared to assist manufacturers and sponsors with the
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Singapore HSA Updates Guidelines on Voluntary Electronic Labelling for Complementary Health Products
The Health Sciences Authority (HSA) Singapore has published the updated guidance document on voluntary electronic labelling for complementary health products (CHP) in August 2022.
There are some questions and answers included
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, manufacturers, suppliers, and software developers in August 2022.
For certain types
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 the request of qualified practitioners in August 2022.
Approval from HSA
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 Medicines (TM) in July 2022.
For HS, the health claims that
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 will cover the entire supply chain, in July 2022.
The system
read more...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 Health Supplements (HS) and Traditional Medicines (TM) in July 2022.
Using
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 bioequivalence (BE) studies in July 2022.
There is an addition of
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 July 2022.
The latest guideline has been updated in accordance with
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