Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Nov 32 min read

Australia's TGA Good Clinical Practice (GCP) Inspection Program

Recently last week (30 October, 2024) the TGA released an updated reference material about the " Good Clinical Practice (GCP) Inspection...

32 views0 comments

Aug 21, 20221 min read

Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information...

584 views0 comments

Aug 19, 20212 min read

Updated Prescription Medicines Registration Process – TGA Australia

Each year, TGA registers approximately 40 new prescription medicines containing new active substances. We refer to these as New Chemical...

45 views0 comments

Aug 19, 20211 min read

Regulation & Re-classification of Software based Medical Devices - TGA Australia

Software-based Medical Devices are medical devices that incorporate or are software, including software as a medical device, or software...

11 views0 comments

Jul 7, 20211 min read

Latest reforms to Post-Market Monitoring of Medical Devices- Australia’s TGA

A recent notice was published by Australia’s TGA details on the latest reforms to post-market monitoring of medical devices. The TGA...

5 views0 comments

Jun 27, 20211 min read

Australian electronic Submission Basics Guide- Australia (TGA)

eCTD and NeeS are the standard electronic submission formats and allow the Common Technical Document (CTD) structure to be provided in an...

20 views0 comments

May 28, 20212 min read

Reclassification of certain medical devices -Australia-TGA

The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019(link is external) were made on 12 December 2019, which...

22 views0 comments

Apr 10, 20211 min read

Submitting data in the eCTD format - Therapeutic Goods Administration - Australia

This information is for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format for...

28 views0 comments

Apr 10, 20211 min read

Submitting data in the NeeS format - Therapeutic Goods Administration -Australia

This information is for sponsors and manufacturers wanting to submit data in the NeeS format for a: prescription medicine biological...

16 views0 comments