On September 17, 2020, the European Alliance for Access to Safe Medicines (EAASM) announced the availability of a report entitled Patient Safety and Nanomedicines: The need for a centralised regulatory procedure. According to EAASM, “[n]anomedicines and their follow-on products, also referred to as nanosimilars, are complex molecules and so regulatory oversight must be scientifically fit for purpose.” The report makes three key recommendations intended to ensure patient safety and enable the European Union (EU) to harness fully the potential of this technology:
- Developing a scientific consensus on definitions for nanomedicines in Europe, improving education and fostering awareness on the complexity and sophistication of nanomedicines among policy makers, prescribers, payers, and patients;
- Adopting a European Medicines Agency (EMA) centralized procedure for all nanomedicines and nanosimilars that would ensure greater scrutiny of these complex products; and
- Clarifying regulatory criteria for the approval of follow-on/nanosimilar medicines. As manufacturing exact replicas of nanomedicines is not achievable, therapeutic similarity will need to be shown through clinical evidence. In addition, the highest possible manufacturing standards must be guaranteed and included in the license application.
EAASM states that with the upcoming EU Pharmaceutical and Industrial Strategies, “it is the right time to set the scene for building a pan-European medical agency consensus so that regulatory weaknesses can be addressed through a robust regulatory pathway and thus provide medicines with the highest quality, safety and efficacy profiles to European patients.” This applies not only to existing medicines but also to “the plethora of new medicines that are in the pipeline.” The report calls upon the European Commission’s (EC) Directorate-General for Health and Food Safety (DG SANTE), EMA, and Member States’ health authorities and regulatory bodies to address unmet medical needs and enhance quality, safety, and efficacy of nanomedicines and nanosimilars by addressing patient safety issues due to significant regulatory challenges across Europe.