Spring Intro 2023

30/03/2023

Who ?

The Committee for Orphan Medicinal Products (COMP) • EMA Committee responsible for evaluating orphan designation applications

Other responsibilities • developing and establishing an EU-wide policy • drawing up detailed guidelines • liaising internationally

The Organisation for Professionals in Regulatory Affairs

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When, How and Where ?

• Can apply at any stage of development prior to MAA submission • COMP Rapporteur & EMA Scientific Officer co-ordinate • By Day 60 - summary report on the application with list of questions and potential invitation to oral explanation • COMP adopts opinion within 90 days • EC Decision will be adopted within a further 30 days • Sponsor can appeal a negative opinion within 90 days of receiving opinion • Annual reports • Following grant of designation, sponsor must submit annual report on development activity of product during previous 12 months

• e.g., nonclinical, clinical pharmacology, clinical studies

until MAA submission

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The Organisation for Professionals in Regulatory Affairs

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