Australia will accept the assessments of medical devices and medicines from trusted international regulators like the US FDA and the European Medicines Agency under significant changes just announced.
The reforms will slash duplication and allow Australian manufacturers to respond more quickly and effectively to global trends in the development and manufacture of therapeutic goods.
Currently, there can be delays of more than a year between approval from an international regulator and the TGA’s own process. The reforms greatly improve time-to-market for innovative products and iterations of existing products – by accepting the judgment of countries with trusted comparable regulation.
Delays in Australia’s TGA approval have taken on increasing importance in recent years as emerging countries have required “country of origin” approval for medical devices. This means dozens of countries like India and China require Australian government approval before medical device makers such as Cochlear can apply for approval in those large and growing markets.
The recommendations of the review, chaired by respected health administration veteran, emeritus professor Lloyd Sansom, brings Australia into line with other international regulators and will increasingly see Australia become a ‘world-first’ destination for the registration of breakthrough medicines.
Minister Sussan Ley said the reforms strike the right balance between consumer protection and reducing red tape for companies manufacturing new medicines, medical devices or complementary medicines.
“The reforms will foster innovation for small and medium sized enterprises by helping Australian businesses navigate the regulatory processes for the supply of therapeutic products in Australia,” Minister Ley said.
“Greater use of assessment of medicines by comparable, trustworthy overseas regulators is estimated to bring medicines from companies that use this assessment pathway to market four and half months earlier than under the current regime.”
Some life-saving medicines such as new cancer drugs may come to market two years sooner, she said.
The government allocated $20.4 million in the last federal budget to implement reforms to the regulation of therapeutic goods in Australia.