Module 6

04 October 2024

Have you heard about it? (3)

An Agency perspective: the success and failure of a medicinal product in the EU

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Classified as public by the European Medicines Agency

50

Take home messages

• Every application is different, what matters is establishing a positive/benefit risk balance for the medicine to support a regulatory approval • Early dialogue is essential and promote efficient use of available tools for early access and development of better medicines • Understanding regulatory requirements and their impact on the clinical development is key to the success of marketing authorisation in the EU

• EMA value the contribution of our partners and stakeholders to our work.

• EMA communicate in an open, transparent manner with all of our partners and stakeholders.

51

An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

51

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