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Report: Regulatory research needs for new and follow-on nanomedicines

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Following the 2019 Global Summit on Regulatory Science (GSRS19) on Nanotechnology and Nanoplastics, the European Commission's Joint Research Centre (JRC) has released a technical report summarizing the discussions of almost 200 international scientists, regulators and policy makers present at the Summit.

An annual event co-organized by the JRC and the Global Coalition for Regulatory Science Research, the Summit provided an opportunity for collaboration and discussion on the regulatory policies and practices for nanomaterials and nanoplastics – technologies that are playing an increasingly important role in product innovation and which require easily adaptable regulatory frameworks.

NBCD Working Group (WG) Coordinator, Jon de Vlieger, introduced the NBCD WG and spoke about the science-based regulations for Non-Biological Complex Drugs (NBCDs) and nanomedicines. Showcasing the variation in the regulatory approaches for NBCDs and their follow-on products in the EU, attention was given to the need for centralized procedures to ensure consistency in the scientific evaluation of follow-on products. The session, co-chaired by experts from the JRC, EMA and Health-Canada, was finalized by a panel discussion resulting in a number of concrete recommendations to further share experiences and information. A detailed summary of the session and panel discussion is included in the GSRS19 report, pages 23-31.

The full report ‘perspectives-on-nanotechnology-and-nanoplastics’, with conclusions resulting from the Summit, can be found online here.

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