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EU Regulators Developing Tools For ‘N-Of-1’ Drugs & Platform Technologies

 
• By Eliza Slawther

European regulators are working with global partners to tackle challenges that sponsors face during “N-of-1” trials, where medicines are personalized to the individual, and looking at the regulation of platform technologies.

Rare disease
• Source: Shutterstock

Support for companies developing medicines for rare diseases is built into EU legislation through the Orphan Regulation, but these incentives are not always suitable for products that are being developed for very rare diseases or patient-specific treatments, experts from the European Medicines Agency and European Commission have heard.

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