Australia needs targeted reform to reflect global regulatory environment: Medicines Australia chief

Australian pharma representative body Medicines Australia has put forward its recommendations for consideration in its submission to the Therapeutic Goods Administration’s Expert Review of Medicines and Medical Devices Regulation.

Its chief executive, Tim James, said targeted reform is required to further develop the Australian regulatory system and can adapt and respond to changes in business and technology.

He said: “It’s important that we can identify ways to restructure Australia’s regulatory framework so that it is fit-for-purpose and globally competitive. This is why Medicines Australia has put forwarded recommendations on optimizing work sharing activities with overseas regulatory agencies, creating multiple approval pathways, delivering on long-promised information technology capabilities, and eliminating unnecessary red tape in the registration system.”