EMA and Australia’s TGA collaborate in the area of orphan medicines

During a meeting last week at the European Medicines Agency, the EMA’s executive director, Guido Rasi, and the national manager of the Australian Therapeutics Goods Administration (TTG) John Skerritt, announced today that the two regulators have agreed to share the full assessment reports related to marketing authorizations of orphan medicines, which are intended to treat rare diseases.

If the same marketing-authorization application is received in parallel by the 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.

Will help accelerate rare disease medicines access