Hong Kong Drug Office Publishes Information on Requirement of Elemental Impurities Levels or Limits
Hong Kong Drug Office has published a guideline on the requirement of elemental impurities levels or limits in registered pharmaceutical …
MDA Malaysia Publishes Guidance Document on Refurbished Medical Devices
The Malaysian Medical Device Authority (MDA) has published a guidance document on the requirements for refurbished medical devices in January …
Singapore HSA Publishes Revised Guidance on Grouping of Medical Devices for Product Registration
The Health Sciences Authority (HSA) Singapore has published the latest guidance document on the grouping of medical devices for product …
NPRA Malaysia Issues Latest Drug Registration Guidance Document
National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued the latest updated version of the Drug Registration Guidance Document (DRGD) in …
Australia TGA Publishes Guidance on Standards for Biologicals for Labelling Requirements
The Therapeutic Goods Administration (TGA) Australia has published a new guidance on Therapeutic Goods Orders (TGO) 107 to provide a …
Australia TGA Publishes Frequently Asked Questions on Software-Based Medical Devices
The Therapeutic Goods Administration (TGA) Australia has published a set of frequently asked questions (FAQs) on software-based medical devices in …
Philippines FDA Publishes Update on Transfer or Refund of Payments
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2021-027, which is the revised guidelines for the …
Hong Kong Drug Office Publishes Latest Guidance for Import and Export Licences
Hong Kong Drug Office has published an updated guidance document for the application of import and export licences for pharmaceutical …
Australia TGA Updates Guidance on Regulation of Listed Disinfectants
The Therapeutic Goods Administration (TGA) Australia has published the updated guidance document on the regulation of listed disinfectants in December …