Update on the European Commission/EMA–FDA bilateral of 18-19 June 2018
Senior officials from the European Commission (EC), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) held their 2018 bilateral meeting in Brussels, Belgium, on 18 and 19 June. The two-day bilateral regulatory dialogue allowed the strategic partners to review their ongoing cooperative initiatives, discuss strategic priorities for the coming years and further strengthen the continuous close collaboration with specific action in the field of pharmaceuticals. The collaboration between EMA and FDA formally started in 2003 and has gone from strength to strength. The two agencies have daily interactions, most of them structured around working groups or ‘clusters’, with the aim to advance scientific and regulatory excellence worldwide.EMA and FDA have significantly increased their level of collaboration in order to engage the patients to share their experiences & their activities .The patients should be aware of the development, evaluation and post-authorization activities related to medicines. They agreed to have more collaboration in inspections and data integrity, safety monitoring of medicines, biosimilars, pediatric medicines, rare diseases, timely access to new medicines and veterinary medicines .What is more important, is the fact that the collaboration in the field of rare diseases will result in significant achievements. Medicine developers can use a common model for requesting orphan designation of their medicine in the EU and the US. FDA will establish a joint working group, the Team of International Global Rare Disease Experts (TIGRE), to enhance the safety & effectivity level of the drugs for children who suffer from rare diseases.