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 …
Hong Kong Drug Office Publishes Frequently Asked Questions for Clinical Trial Certificates
Hong Kong Drug Office has published a set of frequently asked questions on the application for clinical trial certificate (CTC) …
MDA Malaysia Publishes Guideline on Re-registration of Registered Medical Device
The Malaysian Medical Device Authority (MDA) has released the first edition of the guideline on the re-registration process for registered …
Australia TGA Publishes Latest Clinical Evidence Guidelines for Medical Devices
The Therapeutic Goods Administration (TGA) Australia has released the latest guidelines on clinical evidence requirements for medical devices, including in …