Articles

The TGA is updating information for nitrosamine impurities in medicines including acceptable intakes (AI).

The Prescription Medicines in Pregnancy database has been updated to include new and amended entries.

Information for health professionals about medicines with safety related updates to their Product Information.

Information for health professionals about medicines with safety related updates to their Product Information.

An updated warning about the risk of sudden cardiovascular death has been added to the Product Information and Consumer Medicine Information documents for azithromycin.

The TGA reminds businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including prescription-only weight loss medicines.

We are advising sponsors of updates to the Generic Medicines Work-Sharing Initiative (GMWSI) operational procedures.

Following an extensive internal and external consultation process, we have adopted the following 13 international scientific guidelines.

Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates.

Information for health professionals about medicines with safety related updates to their Product Information.

Infringement notices were issued to businesses and individuals for the alleged unlawful advertising of prescription-only medicines on their websites.

Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6) have been made resulting in compounded GLP-1 RA products no longer being able to be compounded by pharmacists and supplied to patients.

Some online health clinics are advertising and selling compounded medicines. However, it is important to know that compounded products are not identical to TGA approved products.

An infringement notice of $18,780 has been issued to Myers Pharmacy Pty Ltd for the alleged unlawful advertising of Ozempic, a prescription-only medicine.

Infringement notices totalling $171,972 have been issued to Better Leaf Pty Ltd, and an individual, for the alleged unlawful advertising of medicinal cannabis on its website and social media.

TGA officers executed a search warrant on a Sydney residence linked to an individual suspected of being involved in the manufacture and sale of compounded semaglutide.

The Prescription Medicines in Pregnancy database has been updated to include new and amended entries.

The targeted consultation is part of a proposal to change the Therapeutic Goods Regulations 1990 to mitigate safety risks in the compounding of GLP-1 RAs.

Announcement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice inspections of third country manufacturers.

The TGA has issued 13 infringement notices totalling $42,900 to a New South Wales-based individual for the alleged unlawful advertisement and supply of erectile dysfunction medicines.

If your business is involved with medicinal cannabis, read our updated guidance about advertising medicinal cannabis to consumers.

We are advising sponsors, who are intending to register new prescription medicines, of a new way to pursue work-sharing for priority applications.

We've created a new GMP clearance Sponsor Information Dashboard (SID) to provide industry with current information about our processing times, workload and key messages. We have also updated our GMP clearance guidance.

Find out about how GMP clearances for manufacturing sites in Bulgaria can now be assessed via the Mutual Recognition Agreement (MRA) pathway.

Information about GMP clearances issued via the MRA Pathway that expire on 31 December 2023 as well as information on the ongoing use of the GMP clearance questionnaire.