The European Commission’s long-awaited package of proposals for overhauling and modernizing the medicines legislative and regulatory framework was finally released on 26 April, comprising a new draft Regulation and Directive alongside two initiatives to help tackle antimicrobial resistance.
As widely expected, the package includes cuts in the regulatory data and market protection periods for new drugs, albeit with the possibility to build up additional years of protection by, for example, launching the product in all EU markets or targeting major unmet medical needs