Delay to Australia and European Union mutual recognition
This article was originally published in Clinica
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...
The FDA’s OPQ touts approval of sixth and seventh continuously manufactured drugs and quicker delivery of inspection results in latest annual report.
No device-related warning letters were released by the US FDA the week of 19 February.
Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.