The European Commission’s Pharmaceutical Strategy and the forthcoming revision of the medicines legislation represent a “unique” opportunity to remedy the deficiencies of the EU drug regulatory system and to implement a much lighter and more agile approach to medical product oversight at the European Medicines Agency, according to Sabine Atzor of Roche.
In future, more integrated products will be submitted to the EMA for assessment, including combinations of pharmaceuticals, diagnostics and digital...
