In less than a couple of years, the European Union has adopted new rules applicable to post-marketing surveillance of medicinal products (“the new pharmacovigilance package”), additional measures to mitigate the risk that falsified medicines are placed into the distribution channels (“the falsified medicines directive”) and new provisions aiming at tightening and making more effective enforcement procedures (“the Penalty regulation”). In addition, the ordinary legislative procedure concerning a new proposed regulation governing clinical trials and new proposed regulations introducing a mechanism of safety scrutiny and traceability requirements for medical devices is fairly advanced and, at the time of writing this article (January 2014), the concerned regulations are expected to be finally adopted in the next few months. Last but not least, the European Medicines Agency is substantially revising its transparency policy that, although being temporarily delayed due to currently ongoing litigation before the Court of Justice of the European Union, will definitely strengthen the openness approach of the European regulator by granting access to a much broader set of information related to clinical trials. This rapidly evolving scenario requires pharmaceutical and medical devices industry members to thoroughly consider how to best prepare to face the new challenges and to comply with the new requirements set by the revised legal framework.
Reprinted with permission from FDLI.