19/06/2018 Modernising the orphan designation process EMA launches new submission portal today The European Medicines Agency (EMA) has launched a new secure online portal for orphan designation applications. The portal, named ‘Iris’, provides a single space where applicants can submit and manage the information and documents related to their applications […]
19/06/2018 Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU Publication of updated Q+As and practical guidance The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Updates to […]
Heavy workload delays EU report on environmental impact of drugs The European Commission’s much-awaited communication on the environmental impact of pharmaceuticals is at an “advanced stage” but might not be adopted in the near future because of other legislative initiatives on the agenda, an EU official has told EURACTIV.com.
15/06/2018 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2018 PRAC held public hearing on quinolone and fluoroquinolone antibiotics At its June meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) discussed two ongoing safety reviews, as shown in the published agenda. As part of […]
European People’s Party MEP Elmar Brok has a “great understanding” of Greece’s New Democracy leader Kyriakos Mitsotakis, who faces internal party problems and opposes the freshly agreed deal between Athens and Skopje on the name dispute. However, Brok told EURACTIV he hopes for a positive result in the end.
The opening of EU trade negotiations with both Australia and New Zealand presents an opportunity for the parties to strengthen their commitments to protect wildlife, natural habitats and the welfare of animals. The EU should look to TPP-11’s environmental provisions for inspiration, argue Joanna Swabe and Nicola Beynon.