In a meeting at the European Medicines Agency (EMA) on April 4, 2014, 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
authorizations of orphan medicines, which are intended to treat rare diseases.
If the same marketing-authorization 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 authorized in their respective
"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," said EMA in a statement. "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."
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 rationalize international GMP inspections of active substance manufacturers, and as part of multilateral relationships involving other regulatory partners.