Spring Intro 2023

23/03/2023

New centralised HTA

The Organisation for Professionals in Regulatory Affairs

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New centralised HTA – country submissions

Country submissions • Submission to each country still required • Data submitted in EMA package not to be resubmitted • Focused on Economic assessment • Many questions to be addressed: • How is the joint clinical assessment be incorporated into the country decisions? • What additional data can be used in the country submissions? • Can we restrict to specific populations in national submissions? • How to approach the regular renegotiations?

The Organisation for Professionals in Regulatory Affairs

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