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THE NANOMEDICINE REGULATORY COALITION

Nanotechnology

Nanotechnology is a compelling and growing scientific field that provides numerous opportunities for life science organisations to develop innovative medicines to address unmet medical needs.

Nanomedicines

Nanomedicines may exhibit a complex mechanism of action combining mechanical, chemical, pharmacological as well as immunological properties.

Nanosimilars

Nanosimilars are follow-on products after the originator nanomedicine’s patent has expired. A nanosimilar is a nanomedicine which should be highly similar to the originally approved product.

In spite of the opportunities they bring, nanomedicines are highly complex and their quality attributes are closely linked to their manufacturing process. Changes in quality, safety, efficacy, 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.

In order to ensure their safety and efficacy, it is therefore essential that a robust regulatory process exists and that all stakeholders, including health authorities, payers, pharmacists and prescribers are fully aware of their complexities.

3 key recommendations to ensure patient safety and enable the EU to efficiently fully harness the potential of nanomedicines:

1

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, payors and patients;

2

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 patient safety;

3

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.

Sign the petition

In the absence of clarity on nanomedicines and nanosimilar regulatory pathways and a legal definition, more scientific, policy and practical knowledge on the quality, safety, and efficacy of nanomedicines and nanosimilars must be gained among all stakeholders, including payers and health care professionals.
Sign the petition

Petar VITANOV

Bulgaria
Group of the Progressive Alliance of Socialists and Democrats in the European Parliament

Pietro FIOCCHI

Italy
European Conservatives and Reformists Group

Radka MAXOVÁ

Czechia
Group of the Progressive Alliance of Socialists and Democrats in the European Parliament