Pharmacy Daily | Govt responds to TGA review

The government this morning released its long-awaited response to the Review of Medicines and Medical Devices Regulation, which kicked off in 2014 under the leadership of Professor Lloyd Samson, Will Delaat and Professor John Horvath.

The response has been keenly anticipated since the final report was delivered to health minister Sussan Ley last year and later publicly released (PD 20 Nov 15).

The government says following consultation with consumers, the industry and health professionals it is supporting the "majority of the recommendations in the review," with a plan to phase in changes over the next three years "in order to maintain continuity of business".

Effective immediately the Department of Health will "commence work on designing implementation of the recommendations with a view to implementing early opportunities in 2016-17," the response advises.

Key changes will include expediting access to innovative and life-saving products via new, abbreviated pathways for approval.

Consumers will also be able to access certain medicines and medical devices that are approved based on assessments from comparable overseas regulators.

There are plans to develop a more comprehensive system of post market monitoring which will provide the TGA with better information about emerging safety issues, while access to items under the Special Access Scheme and the Authorised Prescriber Scheme will be streamlined "reducing burden for healthcare professionals and enabling ease of access to products not on the ARTG for individual patients who meet the relevant criteria."

The government has also accepted a key recommendation relating to the advertising of therapeutic goods, which will see the removal of the current arrangements requiring vetting and pre-approval of promotional activities "in favour of a more self-regulatory regime".

The current mechanisms for managing advertising complaints are also set to be disbanded, with a new single agency to become responsible for complaints handling.

Complementary medicines will continue to be regulated by the TGA, with reforms to provide "new pathways where evidence of efficacy will be reviewed by the TGA prior to market".

And a real-time catalogue of approved ingredients for use in listed medicinal products will also be developed, for access by both sponsors and the general public.

View the response at tga.gov.au.