CRED ERP 25

01/07/2025

Main tasks of the CAT

• Prepare a draft opinion on each advanced therapy medicinal product (ATMP) application before the CHMP adopts a final opinion

• Upon request, opinion on any scientific matter relating to ATMPs

• Participate in procedures for ATMP classification and certification

• Contribute to other procedures and activities as needed (e.g. scientific advice for ATMPs)

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The Organisation for Professionals in Regulatory Affairs

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Main tasks of COMP

• Delivering opinions on orphan drug designation applications

• Providing advice to EU Commission on policy on orphan medicines and assists in drafting detailed guidelines

• Assisting in international co-operation

• Link with patients’ associations

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The Organisation for Professionals in Regulatory Affairs

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