National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued the latest updated version of the Drug Registration Guidance Document (DRGD) in January 2022.
One of the main updates is regarding the updated
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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 detailed explanation for manufacturers, sponsors and those who provide biologicals
read more...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 December 2021.
Software used for health or medical purposes need to
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 transfer and refund of payments made to the FDA. The
read more...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 products and medicines in December 2021.
The applications for these licenses
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 2021.
The main update is based on the changes to the
Singapore HSA Publishes Revised Guidance on Medical Device Product Registration
The Health Sciences Authority (HSA) Singapore has published the latest guidance document on medical device product registration in January 2022.
Under the evaluation routes for the registration of medical devices in
Australia TGA Releases Frequently Asked Questions on Reclassification of Medical Devices
The Therapeutic Goods Administration (TGA) Australia has published a set of frequently asked questions (FAQs) on reclassification of medical devices in November 2021.
One of the most important points to note
Australia TGA Publishes Updates on Personalised Medical Devices
The Therapeutic Goods Administration (TGA) Australia has published the latest document on personalised medical devices, including 3D-printed devices, in November 2021.
For patient-matched medical devices, manufacturers and suppliers are exempt from