Further guidance on adaptive licensing pilot project available from EMA
Based on the initial experience gained from its adaptive licensing pilot project, the European Medicines Agency has released a document to address the most frequently asked questions from companies and to clarify the terms of engagement and expected outputs for prospective applicants.
The document clarifies in particular:
- the criteria used by the Agency to select suitable candidates for the pilot project;
- the concrete steps involved in the process and expected outcomes;
- the context and aim of the exploratory discussions between the Agency and selected candidates.
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