Experts: More Transparency Needed in EMA New Drug Approval Process

The European Medicines Agency (EMA) should increase the transparency of its drug approval process by releasing substantial parts of drug dossiers to the scientific community. Greater transparency would “help independent interested parties define the benefit-risk profile of new medicines before they are allowed onto the market,” according to Silvio Garattini, director of the Mario Negri Institute for Pharmacological Research in Milan, and Vittorio Bertele, head of the institute’s drug regulatory policies laboratory.
International Pharmaceutical Regulatory Monitor