ICH

TGA medical devices

The Medical Device Single Audit Program

In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, …

National Commission of Audit and the TGA

The National Commission of Audit Recommendation 19 could significantly improve the cost and time to market for new drugs. The Commission cites the example of Atorvastatin, currently the most highly prescribed and highest cost to government medicine in Australia, …

TGA signs agreement for eCTD submissions

The TGA has announced that it has signed an agreement to use the docuBridge® software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).