Australians would have faster access to certain new drugs and devices under a reform blueprint that would require local regulators to focus more on post-market monitoring and surveillance.

A government-commissioned review has found the Therapeutic Goods Administration was well-regarded internationally — more so for its handling of drugs than devices — but in need of reforms to cope with the “rapid pace of innovation and change”.

A three-speed regulatory system has been proposed to ensure new drugs with sufficient overseas approvals, or unique requirements, are fast-tracked on to the Australian market. The channels for generic drugs and biosimilars — which have a different composition than patented drugs but similar effects — would be two-speed, again with those products sufficiently assessed overseas given expedited approval.

Similar reforms are recommended for devices, following the government’s decision to allow European approvals in place of Australian approvals. Unapproved therapeutic goods would also face fewer regulatory hurdles, while Class 1 devices would be reassessed with a view to classifying more as consumer goods.

In moving to reduce red tape for manufacturers and distributors, the review has called for a corresponding increase in surveillance. The review panel — former Pharmaceutical Benefits Advisory Committee chairman Lloyd Sansom, former chief medical officer John Horvath and former Medicines Australia chairman Will Delaat — wants safeguards to limit the opportunity for manufacturers to game the system.

It follows PBAC criticism of drug manufacturers publicly campaigning for rapid approvals and expensive subsidies despite having only limited evidence of any patient benefit.

For more details, go to: http://www.theaustralian.com.au/business/reforms-to-fast-track-access-to-new-drugs/story-e6frg8zx-1227413495095