Delay to Australia and European Union mutual recognition
This article was originally published in Clinica
Executive Summary
The March election of a new government in Australia has made it difficult to predict when the proposed medical device mutual recognition agreement between Australia and the European Union will be implemented. The MRA was due to come into force on January 1st this year (see Clinica No 676, p 7). Agreement has now been reached on the technical content and the way is clear for the MRA to proceed, reports the Australian Therapeutic Device Bulletin. Officials are scheduled to meet in Brussels during May to initial the agreement. A number of changes to Australia's Therapeutic Goods Act will be required before the MRA can finally be implemented.
You may also be interested in...
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
Top-Selling Drugs 2023: Pharma’s $60bn COVID-19 Cliff
Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.