TGA reforms mean patients get medicines sooner

Changes to the way the Therapeutic Goods Administration evaluates new prescription medicines will ensure many medicines become available to patients much sooner, Medicines Australia chief executive Dr Brendan Shaw said today.

The TGA’s Business Process Reforms, launched today, will reduce by more than a year the time it takes the regulator to evaluate many medicines for quality, safety and efficacy.

“Australian patients are the big winners out of these reforms,” Dr Shaw said.

“The evaluation and registration of new prescription medicines currently takes up to two years. The new process will reduce that time to between nine and 11 months.

“New submissions lodged with the TGA will spend less time waiting in queues at different stages of the assessment process. That will make for a much more effective and efficient system, without compromising on rigour.”

Dr Shaw said the TGA reforms compounded with the PBS improvements set out in Medicines Australia’s MoU with the Commonwealth should significantly reduce the time it takes a new medicine to become available.

“The MoU will allow the cost-effectiveness analysis of a new medicine for PBS listing to be undertaken at the same time as the TGA evaluation for quality, safety and efficacy.

“These improvements, together with the TGA reforms, can deliver a significant improvement to patient health outcomes.

“Many ordinary Australians will have earlier access to the medicines they need.”

Dr Shaw said Medicines Australia member companies would support the TGA in managing any teething problems that arise from the reforms over the course of the initial 12-month transition period.

“There may well be the odd hiccup in the early stages, but these reforms herald a major improvement in the way innovative new medicines are evaluated.

“The significance of today’s announcement should not be forgotten. Some of these reforms have been waiting for many years to be implemented, so to finally see them implemented today is a credit to the Government, particularly the TGA.

“The constructive way in which the TGA worked with all stakeholders, including industry, to secure these reforms is to be commended and is indicative of the TGA’s professionalism and integrity.

“I congratulate the TGA, and TGA National Manager Rohan Hammett, in particular, on implementing these reforms.”


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