Newsletters
EARLPublic consultations
Stakeholders can contribute to public consultations and various feedback mechanisms throughout the policy cycle.
Below are summaries and links to the consultations to which the EANM has recently responded.
As an umbrella organisation for nuclear medicine professionals across Europe, the open consultation on the follow-up to Euratom’s research and training programme for the period 2026-27 is a major topic for the EANM. The EANM has shared some insights on to leverage Euratom’s research and training programme for medical applications of ionising radiation.
May 2024
The EANM supports the initiative to revise the guideline to include a section on 3Rs terminology, as well as annexed guidance for regulatory acceptance of Microphysiological Systems (MPS), including Organ-on-Chip (OoC) models, for specific Contexts of Use (COUs) within the pharmaceutical area. We recognise the importance of establishing clear definitions for 3Rs-related terms to facilitate alignment among stakeholders and to provide clarity on regulatory requirements for the qualification of New Approach Methodologies (NAMs).
Regarding the proposed revisions, the EANM offered several insights and suggestions from the nuclear medicine perspective.
February 2024
The European Medicines Agency (EMA) is in the process of revising its Guideline on Radiopharmaceuticals, which was last updated in 2008. With significant advancements and innovations in Radiopharmaceuticals over the past 16 years, it has become essential to modernise this guideline.
This revision aims to: 1) Provide further clarity on issues that have led to non-harmonised interpretations, 2) Address topics that were inadequately covered or detailed in the current guideline, 3) Offer guidance on emerging issues resulting from recent developments and evolving practices.
A consultation process has been taking place open to all the stakeholders who wish to share their input and feedback with the EMA.
The EANM has replied to the consultation:
- on the Concept Paper on the revision on the Guideline on Radiopharmaceuticals
- and on the Concept Paper on the revision of the Guideline on Radiopharmaceuticals based on Monoclonal antibodies
October 2023
As part of the SAMIRA Action Plan’s pillar on the security of the supply of medical radioisotopes, the European Commission plans to establish a European Radioisotope Valley Initiative (ERVI), aiming at maintaining Europe’s global leadership role in the supply of medical radioisotopes. To further define this initiative’s objectives and scope, the European Commission launched a targeted consultation over the autumn to gather stakeholders’ positions on the ERVI objectives and the specific issues concerning the supply chain of medical radioisotopes.
The EANM provided feedback, highlighting the crucial need for such an initiative, given the recent large and unexpected outages ultimately impacting patients’ procedures and considering that the demand for radionuclides will only increase in the future.
The EANM pointed out that, for such an initiative to be a success, a holistic approach should be taken:
- Considering the entire supply chain so that the produced radioisotopes are easily available anywhere in Europe at a fair price.
- Ensuring that the EU’s strong tradition in Nuclear Medicine will perpetuate in the next decades by reducing the EU’s reliance on foreign suppliers.
- Focusing on the development of new radioisotopes and new production methods.
October 2022
In the context of the review of the International Commission for Harmonisation’s (ICH) Guidelines on Analytical Procedures (Analytical Procedures Development and Validation of Analytical Procedures), which opened for public consultation in July 2022, the EANM provided feedback, emphasizing the unique requirements of radiopharmaceuticals within regulatory frameworks.
The EANM highlighted that while these guidelines serve as a general basis for developing and validating analytical methods for most drug substances and products, they do not fully cover the specific tests needed for radiopharmaceutical analysis. Therefore, radiopharmaceuticals should be excluded from the scope of the ICH analytical procedures guidelines. To address this gap, the EANM, in collaboration with EDQM, has developed a guideline on validating analytical methods for radiopharmaceuticals in recent years.
July 2022
With the publication of an initiative on NCDs, ‘Healthier Together’, the European Commission aimed at supporting European countries in reducing the burden of NCDs. The initiative, focusing on five main areas (including cardiovascular diseases, diabetes, chronic respiratory diseases, mental health and neurological disorders, and health determinants), will provide support for EU countries all along the care pathway by developing guidelines, rolling out innovative approaches, transferring best practices and using EU funding instruments.
The EANM has been involved in the consultation process for the neurological and cardiovascular strands. The main elements of our reply included the following:
- Elaborating a European system for data generation and collection on NCDs
- Harmonisation of cardiovascular and neurological data for PET/CT scans
- Harmonisation of proof-of-concept studies for Radiopharmaceuticals.
May 2022
In the context of the upcoming review of the European Pharmaceutical Legislation (Directive 2001/83 EC), the EANM has provided feedback to the related public consultation, highlighting the current regulatory challenges for radiopharmaceuticals.
Given the recent innovations in nuclear medicine, the nuclear medicine community believes that it is reasonable that the requirements laid out in Directive 2001/83 EC, which is also applicable to radiopharmaceuticals, need to be revised. The challenges posed by implementing this outdated regulatory framework manifest in different ways, but mainly resulting in an increased level of heterogeneity in the interpretation of the Directive among Member States and, ultimately, a negative impact on the availability of radiopharmaceuticals due to an unsure legal basis.
In this respect, the EANM sees the need for the adaption of Directive 2001/83 in the following areas:
- Definition of terms to reflect today’s nuclear medicine and radiopharmacy practices
- Differentiation in regulations between kit-based radiopharmaceuticals preparation and complex radiopharmaceuticals preparation
- Differentiation in regulations considering production settings (commercial vs in-house)
- Evaluation of dedicated guidelines for the in-house preparation of radiopharmaceuticals for non-commercial use within healthcare establishments could be implemented in the revision
December 2021
As part of the EU pharmaceuticals strategy and drawing lessons from the COVID-19 pandemic, the European 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. Legal proposals to review Directive 2001/83/EC and Regulation EC/726/2004 are expected by the end of 2022. The EANM’s main points of concern have been summarised in a briefing paper.
November 2021