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
Regulatory News
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
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 (HS) and traditional medicines (TM) in July 2022.
There are two
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 on labelling drug products under Maximum Retail Price (MRP), in
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) in June 2022.
The document covers some pertinent topics, including the
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 medical devices in June 2022.
There are two stages for the
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 vitro diagnostic medical devices (IVDs), in June 2022.
One of the
Philippines FDA Publishes Circular on Abridged and Verification Review Pathways
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2022-004, which provides insight on the facilitated registration pathways (FRPs) available for new drugs (including vaccines and biologicals),