The European Technology Platform on Nanomedicine (ETPN) has recently analyzed and commented the proposed European Commission’s revision of pharmaceutical legislation, advocating for the nuanced recognition of nanotechnology’s unique potential and challenges within the healthcare sector. We are happy to share today the key messages and full version of the ETPN feedback on Revision of the EU general pharmaceuticals legislation (Nov 23) with our members and the broader European Nanomedicine community, highlighting the importance of considering nanomedicine in the evolving regulatory landscape.

What is new in the revision of the EU pharmaceutical legislation?

For context, you can review the European Commission’s proposed revision of pharmaceutical legislation.

As part of the EU pharmaceuticals strategy, and drawing lessons from the COVID-19 pandemic, the Commission plans to evaluate and revise the EU’s general legislation on medicines for human use to ensure a future-proof and crisis-resistant medicines regulatory system.The aim of his new EU phamar legislatuion is multi-faceted:

• Ensure access to affordable medicines
• Foster innovation, particularly in areas of unmet medical needs
• Improve security of supply
• Adapt to new scientific and technological advancements
• Reduce administrative burden (red tape)

What is ETPN’s feedback on the EU pharma revised legislation, in which “nano” is absent.

Involvement & Purpose:

This revision of legislation presents a pivotal opportunity for the nanomedicine sector. Recognizing this, ETPN has actively participated in providing detailed feedback, ensuring that the voice of nanomedicine is heard in this significant policy overhaul.

As a leading entity in the European nanomedicine landscape, ETPN gathered individual contributions, insights and perspectives from its community of over 130 members across 27 countries. This collective feedback prepared by the ETPN Secretariat represents a unified stance from academia, industry, and healthcare professionals within the European nanomedicine community, aiming to influence policy for the betterment of healthcare innovations.

Executive Summary of the ETPN Feedback

ETPN feedback on Revision of the EU general pharmaceuticals legislation (Nov 23)

• The European Technology Platform on Nanomedicine (ETPN) finds the new EU pharmaceutical legislation largely aligned with its objectives of enhancing drug availability, accessibility, and innovation. It commends the efforts to expedite EMA authorization timelines and address drug shortages but suggests greater industrial accountability and supply chain security strategies. The legislation’s commitment to sustainability and antimicrobial resistance is supported, yet there is concern over the practical impact and enforcement of such measures.
• Notably, the legislation overlooks the specific mention of nanomedicine, which is concerning given the sector’s growth and the recent prominence of mRNA vaccines. While nanomedicines must adhere to the same standards as traditional drugs, their omission may suggest an underappreciation of their unique contributions and challenges.
• Nanomedicines differ from conventional pharmaceuticals, notably in their potential for reformulating unstable or insoluble drugs and improving pharmacokinetics and toxicity profiles. They do, however, pose regulatory challenges due to their complex composition, characterisation and manufacturing, and the diverse regulatory treatment of their components across regions.
• The ETPN advocates for European support in regulatory science and a transparent dialogue between providers and regulators. It regrets the funding cessation for initiatives like the EUNCL that standardised nanomedicine characterization but continues to participate in EU projects like METRINO and NANOSPRESSO-NL for advancement in the field.
• There is a consensus among ETPN members on the need for nuanced nanomedicine regulations, with specific protocols and international alignment for fostering global competitiveness. ETPN is ready to contribute to the evolution of such regulations to ensure the continued advancement of nanomedicines.
• In conclusion, the ETPN emphasises that the role of nanomedicines should focus on significant medical value, ensuring their place in addressing unmet clinical needs and justifying their future reimbursement. The absence of explicit mention of nanomedicinal products in the revised legislation warrants vigilance, ensuring this is not mistaken for a lack of interest in the field. ETPN seeks to enhance clinical readiness and regulatory guidance for nanomedicines and invites dialogue to shape a resilient regulatory future for medicines in Europe. Contact for further discussion: secretariat@etp-nanomedicine.eu.

What will you find in our the full ETPN feedback document?

Feel free to  download, read and share our feedback document by clicking here.

• About Nanomedicine and the ETPN
• Evaluation of the Objectives of the Revised Legislation
• Alignment of the New Legislation with Stated Objectives
• The Notable Absence of Nanotechnology and Nanomedicine in the Proposed Revision
• Specific Advantages & Challenges of Nanomedicines
• The Need for Guidance and Support in Nanomedicine
• Potential Coverage of Specific Regulation for Nanomedicinal Products in the Future
• Conclusion and the Way Forward

Take-home messages from ETPN

• Our feedback acknowledges the positive steps of the European Commission, while highlighting the absence of specific mention of nanomedicine.
• We emphasize that while nanomedicines adhere to safety and efficacy standards, their unique attributes and specific challenges should be acknowledged in the regulatory framework.
• Rather than advocating for separate regulations, we propose a regulatory approach that recognizes the distinctive aspects of nanomedicine, its potential, and its specific challenges.
• The feedback concludes with a call for ongoing dialogue and collaboration to ensure nanomedicine’s integration and advancement in healthcare.

Get involved!

We invite our members and the broader community to engage with this feedback. Your perspectives are invaluable as we continue to shape the regulatory environment for nanomedicine. We welcome your thoughts and contributions to this crucial discussion. The ETN is committed to fostering the development of nanomedicine. Through collaborative efforts and open dialogue, we strive to ensure that nanomedicine is appropriately recognized and integrated into the European regulatory framework, making a significant contribution to healthcare innovation. Never hesitate to contact us for more insights on EU regulation of nanomedicine: secretariat@etp-nanomedicine.eu.