法国国家计量研究所(LNE)发起了一系列活动,以确定测试方法的优先事项及其协调,直接满足纳米医学的监管需求。其中一个题为“纳米医学国际标准化路线图”的研讨会于2023年10月举行(巴黎,法国)召集了表征纳米药物和含有纳米材料的医疗产品的关键专家,包括欧盟委员会联合研究中心,SINTEF工业和法国计量机构,英国,美国和加拿大,欧盟委员会的两项旗舰举措(PHOENIX和SAFE-n-MEDTECH开放式创新测试床),欧洲药品质量局(EDQM)mRNA疫苗工作组的代表以及国际标准化和规范前组织的成员(包括CEN,ISO,ASTM,VAMAS)。讨论中出现了两个带回家的消息。首先,开发纳米药物的标准测试方法和参考材料(RM)是欧盟委员会和各种利益相关者的关键优先事项。此外,人们一致认识到标准化委员会之间需要统一的方法,监管机构和纳米医学界。在美国,加拿大和欧洲水平,已经讨论了成功案例和未来倡议的例子。未来的前景包括在CEN/TC352下成立一个专门的工作组,以巩固努力并制定纳米医学标准化路线图。
The French National Metrology Institute (LNE) initiated a series of events to identify priorities for test methods and their harmonisation that directly address regulatory needs in Nanomedicine. One of these workshops entitled \"The International
Standardisation Roadmap for Nanomedicine\" held in October 2023 (Paris, France) brought together key experts in the characterisation of nanomedicines and medical products containing nanomaterials, including the Joint Research Centre of the European Commission, SINTEF Industry and the metrology institutes of France, the UK, the USA and Canada, two flagship initiatives of the European Commission (PHOENIX and SAFE-n-MEDTECH Open Innovation Test Beds), representatives of a working party on mRNA vaccines at the European Directorate for the Quality of Medicines (EDQM) and members of international
standardisation and pre-normative organisations (including CEN, ISO, ASTM, VAMAS). Two take-home message came out from the discussion. First, developing standard test methods and Reference Materials (RMs) for nanomedicines is a key priority for the European Commission and various stakeholders. Furthermore, there was a unanimous recognition of the need for a unified approach between
standardisation committees, regulators and the nanomedicine community. At the USA, Canadian and European level, examples of success stories and of future initiative have been discussed. Future perspectives include the creation of a dedicated Working Group under CEN/TC 352 to consolidate efforts and develop a nanomedicine
standardisation roadmap.