Work is under way on a new European procedure for repurposing off-patent medicines for new uses. It would mainly be used for active substances where there was more than one marketing authorization holder and the relevant data were generated by a third party.
Pharmaceutical industry bodies and the EU regulatory authorities are working on a draft “repurposing framework” that would help to identify and evaluate promising new uses for existing off-patent medicines.
The framework would mainly cover active substances with more than one marketing authorization holder where the MAHs had not taken...
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