CRED 8 Presentations

01/07/2024

Respect the Process – Comparing EMA and FDA Process / Timelines

European procedure: efficient review; slow decision making US procedure: slow review; efficient decision making EU approvals significantly later than US on average ● Minimal use of accelerated approval in EU ● Time between CHMP Positive Opinion and EC Approval

Understand the “why-s” behind the process

The Organisation for Professionals in Regulatory Affairs

5

Respect the People

Regulators are human beings ● Build a relationship based on mutual respect ● Build trust It is all about the patients and public health for all of us ● We are all scientists: It is all about the data ● They have seen the data for all approved and rejected products Regulators know how to deal with uncertainty

The Organisation for Professionals in Regulatory Affairs

6