In June 2022, the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised and hosted a symposium on “Quality requirements for nanomedicines – what role should the European Pharmacopoeia (Ph. Eur.) play?’’, during which the participants expressed a strong interest in having texts on nanomedicines available in the Ph. Eur. The first concrete action taken by the European Pharmacopoeia Commission (EPC) following the symposium was to create a new mRNA vaccines working party at its 173rd session in June 2022.
The feedback from the symposium was also shared with the Ph. Eur.’s Non-Biological Complex Drugs working party (NBC WP), which already had experience with nanomedicines through its work on iron carbohydrate solutions. The NBC WP’s experts welcomed the idea of adding other nanomedicines to their work programme and suggested that the name of the WP be changed to accommodate this expansion. At its 175th session in March 2023, the EPC agreed to intensify the work on standards on nanomedicines, to change the name of the NBC WP to NANO WP (Nanomedicines) and to adjust the terms of reference accordingly.
Specialists with expertise in:
- the development and/or quality control of nanomedicines, preferably but not limited to liposomal formulations,
- the development of analytical procedures for liposomal formulations, or
- the assessment of applications for marketing authorisation in the field (e.g. from licensing authorities, official medicines control laboratories or industry)
and who are interested in joining the Ph. Eur.’s community of experts are invited to consult the Terms of reference for NANO WP experts (see the relevant section of the Terms of reference and profile for members of groups of experts and working parties). It is essential that they also have access to the laboratory facilities needed to verify and validate the analytical procedures proposed for inclusion in monographs.
Applications to join the NANO WP should be made as described on the Join the Network page on the EDQM website.