Work Package 1

WP1 will conduct an analysis of the interrelations between the European pharmaceutical legislation and Council Directive 2013/59/Euratom’s requirements for therapeutic nuclear medicine.

More specifically, WP1 will complete the following tasks.

  • Analyse the interrelations between the authorisation regime for radiopharmaceuticals established under European pharmaceutical legislation and the dosimetry and related optimisation requirements established under the Basic Safety Standards Directive (BSSD)
  • Analyse the applicable legal requirements as well as the relevant regulatory and authorisation instruments and practices established, with the view of identifying specific areas where their coherent implementation could be improved.
  • Conduct a comparative analysis of the applicable regulatory frameworks in the EU, United Kingdom and United States of America

Work Package 2

The objective of WP2 is to develop, undertake and analyse a survey on the practical implementation of the main aspects of European pharmaceutical legislation and the BSSD concerning therapeutic nuclear medicine.

A multi-tiered approach will be taken to evaluate the heterogeneity in the relevant provision for individualised patient-dose planning, including patient-specific dosimetry, radiopharmaceutical preparation, provision and involvement of the MPE, presence and implementation of national legislation and guidance pertaining to selected dose constraints, patient release criteria, and radioactive waste management.

To identify the existing gaps in implementing the above requirements and main barriers encountered in the development and use of therapeutic radiopharmaceuticals, the survey will target a number of European stakeholders across a breadth of aspects pertaining to nuclear medicine therapy. Identified stakeholders include industrial radiopharmaceutical companies, competent authorities and national regulators, national nuclear medicine and medical physics societies, national training schools, and individual experts working in the clinical field.

The survey can be accessed via this link until October 31st. 

Work Package 3

WP3 will identify and implement further actions to advance the coherent implementation of the European legal requirements with respect to therapeutic nuclear medicine, based on the issues identified by WP1 and WP2.

A list of potential issues to be addressed include the following.

  • Lack of European guidance for implementing BSSD, pertaining to the specific difficulties faced in nuclear medicine beyond those encountered in X ray imaging or radiation therapy
  • Lack of consideration in EMA guidance regarding marketing authorisations for items pertaining specifically to safety of radionuclides     
  • Confusion between the requirement for optimisation stipulated in the BSSD and the need to follow the posology of the product used for marketing authorisation
  • Lack of clarity in the need for qualitative assessment of delivery verification or a requirement for quantitative analysis based on dosimetry indices
  • Lack of medical-physics expertise and physicians’ knowledge of dosimetryin many nuclear medicine centres, stifling BSSD implementation
  • Divergent interpretation within the EU regarding the definition of standardised therapeutic procedures
  • Lack of data to make dosimetric comparison for treatment verification
  • Lack of guidance for the establishment of appropriate dose constraints
  • Lack of harmonisation regarding criteria for patient release from hospitals and management of radioactive waste across member states
  • Lack of clarity of the level of optimisation required to comply with European directives on, e.g., patient selection, imaging, dosimetry

Work Package 4

WP4 will organise a workshop to present and validate the results of the work carried out under WPs 1–3 and discuss issues relating to regulations, development and use of therapeutic nuclear medicine with the relevant stakeholders.

More specifically, WP4 will perform the following.

  • Define the workshop date, format and target group
  • Set up the workshop programme
  • Take care of the organisational aspects, including dissemination/promotion of the workshop, handling of registration, speaker/moderator invitations and onsite/hybrid formats
  • Prepare the proceedings of the workshop

Target group

The workshop will bring together the following groups.

  • European and national authorities responsible for authorisation of radiopharmaceuticals
  • Competent authorities for radiation protection
  • Researchers and experts in the area of radiation protection and radiopharmaceuticals
  • Nuclear medicine community
  • Medical physics community working in the field
  • Patient organisations
  • Radiopharmaceutical industry
  • Relevant clinical communities, e.g., endocrinology, urology

In addition, the Advisory Board members as well as the SAMIRA SGQS and Article 31 WP MED, in alignment with the EC, will be invited to join the workshop.