PRESS RELEASE: New report ‘Patient Safety and Nanomedicines: the need for a centralised regulatory procedure’ calls to ensure patient safety through regulatory clarity

Brussels, 17 September 2020 – On World Patient Safety Day 2020, the European Alliance for Access to Safe Medicines along with several organisations launches its new report entitled “Patient Safety and Nanomedicines: the need for a centralised regulatory procedure”. Nanomedicines and their follow-on products, also referred to as nanosimilars, are complex molecules and so regulatory oversight must be scientifically fit for purpose.

Nanomedicines enhance the way that medicines target and reach areas of disease within the body opening up new therapeutic options. They offer potential solutions for current treatment challenges, such as cancer, cardiovascular and neurodegenerative diseases, as well as other illnesses.

Moreover, follow-on nanomedicines / nanosimilars are receiving more and more attention since patents of reference products are expiring. However, their complexity creates challenges in establishing the accurate comparability of physicochemical characteristics and thus demonstrating the equivalence of the product.

Changes in quality, size distribution, surface properties, drug loading and release profile, aggregation status and stability can alter how a nanomedicine acts within the body with a significant impact on patient safety and efficacy.

This report makes 3 key recommendations to ensure patient safety and enable the EU to fully harness 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 an EMA centralised procedure for all nanomedicines and nanosimilars which would ensure greater scrutiny of these complex products. This is key to avoid diverging approaches between Member States and ensure long-term safety and risk management;
  • 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 licence application.

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 not only applies to existing medicines but the plethora of new medicines that are in the pipeline.

The report calls upon DG SANTE, the EMA, 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.

The report is available here.

Visit the EAASM website to sign the Petition and endorse more collaborative actions for a new and robust regulatory framework for nanomedicines and nanosimilars in Europe.


The European Alliance for Access to Safe Medicines (EAASM) is a non-profit, independent, pan-European initiative which represents a multi-sectorial coalition of organisations dedicated to protecting patient safety by ensuring access to safe and legitimate medicines. To find out more about the EAASM, please visit the website and follow @EAASMeds on Twitter.


The European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) is one of the biggest nephrology associations worldwide. It leads European nephrology and is one of the most important European medical associations. The objects of the Association are the advancement of medical science by promoting fundamental and clinical advances in the field of nephrology, dialysis, renal transplantation, hypertension, and related subjects. To find more about ERA-EDTA, please visit the official website  and follow @eraedta on Twitter.


The European Specialist Nurses Organisation (ESNO) is a non-profit organisation whose main goal is to facilitate and provide an effective framework for communication and co-operation between the European Specialist Nurses Associations and their constituent members. ESNO represents the mutual interests and benefits of these organisations to the wider European community in the interest of the public health. Members of ESNO consist of individual European specialist nurses’ associations.