Module 1 2021

30/06/2021

 PRIME – Priority Medicine ● Early Dialogue with HA and support during development  Innovation Task Force ● Early Dialogue for emerging therapies (ATMPs), emerging technologies, and borderline therapeutics (pharmaceuticals plus devices) for which there is no established EMA experience  Accelerated Review ● 150 day procedure instead of 210 days  Exceptional circumstances ● If it is not possible to collect comprehensive data (i.e. ultra rare diseases)  Conditional Approval ● Package not complete at time of submission  Orphan Medicinal products, Options for Small Medium Enterprises, Paediatric Medicines  Rolling review ● Ad-hoc procedure in the context of a public health emergency Options with EMA -Centralised Procedure

The Organisation for Professionals in Regulatory Affairs

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PRIME: Priority Medicines Strategic Choice

 Enhanced support for development ● Voluntary, to be requested ● Medicines that target an unmet medical need; ● May offer major therapeutic advantage, or benefit patient without treatment options ● Based on enhanced interaction and early dialogue with developers of promising medicines; – Scientific Advice – Accelerated Assessment;  Regular Meetings ● Rapporteur from CHMP/CAT to help build knowledge ● Guidance on overall development plan and regulatory Strategy; ● Scientific Advice at key development milestones;

The Organisation for Professionals in Regulatory Affairs

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