EMA and Australian regulator strengthen collaboration in the area of orphan medicines

In a meeting at the European Medicines Agency (EMA) on 4 April 2014, the EMA’s Executive Director, Prof. Guido Rasi, and the National Manager of the Australian Therapeutic Goods Administration (TGA), Prof. John Skerritt, announced that the two regulators have agreed to share the full assessment reports related to marketing authorisations of orphan medicines, which are intended to treat rare diseases.

If the same marketing-authorisation application is received in parallel by EMA and TGA, the two regulators have the possibility of scientific exchange to facilitate the evaluation of the medicine. Both regulators will still reach their own conclusions about the suitability of each medicine to be authorised in their respective markets.

The agreement will reinforce collaboration and work-sharing between the two regulatory authorities and will contribute to accelerating access to new medicines for patients with rare diseases in Europe and in Australia. Global collaboration on orphan medicines and rare diseases is particularly important in view of the small number of patients worldwide and the need for the limited number of studies performed to benefit patients regardless of where they live.

Under the framework of greater international work-sharing, the EMA and TGA also collaborate and exchange information in a number of other areas, including through a mutual recognition agreement on good manufacturing practice (GMP) for medicines, their work to rationalise international GMP inspections of active substance manufacturers, and as part of multilateral relationships involving other regulatory partners.