Table 2.

Examples of international associations and initiatives for global harmonisation active in the field of nanotechnology-enabled health products

Name of the organisation/platform	Description
European Federation of Pharmaceutical Sciences (EUFEPS) (https://www.eufeps.org/nano-network.html)	EUFEPS Network on nanomedicine should focus on pharmaceutical and biomedical sciences and the diagnostics and therapeutic aspects of nanomedicine, primarily in cooperation with related nanotechnology fields such as optics, bioinformatics to achieve a wide range platform for pharmaceutical researchers in this field
Global Bioequivalence Harmonisation Initiative (GBHI) (https://pubmed.ncbi.nlm.nih.gov/34481066/)	The GBHI conferences are organised by EUFEPS in collaboration with American Association of Pharmaceutical Scientists (AAPS). The initiative aims to offer the most informative and up to date science and regulatory thinking of bioequivalence in global drug development to support the intended process of a scientific global harmonisation
Lygature (https://www.lygature.org/non-biological-complex-drugs-nbcd-working-group#project-update-1696)	The Non-Biological Complex Drugs (NBCD) Working Group was established to stimulate discussion of the safety and efficacy of NBCD innovation and follow-on products
International Symposium on Scientific and Regulatory Advances in Biological and Non – Biological Complex Drugs (SRACD) (http://sracd.hu/main-topics/)	A series of symposia addressing regulatory aspects of biological and non-biological complex drugs and the paradigm shift compared to the requirements for fully characterised small molecular drugs and the established formulations
European Foundation for Clinical Nanomedicine (CLINAM) (https://clinam.org/?page_id=102)	The recognition of the large future impact of nanoscience on medicine and the observed rapid advance of medical applications of nanoscience has been the main reasons for the creation of the CLINAM Foundation
Global Coalition for Regulatory Science Research (GCRSR) (https://www.fda.gov/about-fda/science-research-nctr/global-coalition-regulatory-science-research)	The Global Summit on Regulatory Science (GSRS) is an international conference for discussion of innovative technologies and partnerships to enhance translation of basic science into regulatory applications within the global context
EDQM’s Working Party on Non-Biological Complexes (NBC) (https://www.edqm.eu/en/groups-experts-and-working-parties)	The aim of the working party is the elaboration and revision of monographs on non-biological complexes (e.g. iron sucrose concentrated solution)