CRED 8 Presentations

01/07/2024

Notification of intention to submit application 7 months before submission • Refer to published submission timetables ( standard/ATMP/accelerated ) - consider carefully and be realistic based on document completion dates • Keep Agency informed of any changes! ( workload/resource planning )

You will need an EMA account!

•

• See “Pre-authorisation guidance – section 2: Steps prior to submitting the application”

The Organisation for Professionals in Regulatory Affairs

Abbreviations: ATMP – Advanced therapy medicinal product

43

Request for Assignment of Rapporteurs 7 months before submission • Appointment of Rapporteurs requested as part of intent to submit. • The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) both appoint (co-)rapporteurs to conduct the scientific assessment • For advanced therapy medicinal products, (co-)rapporteurs are also appointed from members of the Committee for Advanced Therapies (CAT), who will lead the assessment • Appointed by CHMP members per expertise in therapeutic area (not per Applicant proposal/preference!) • See “Pre-authorisation guidance – section 2: Steps prior to submitting the application”

The Organisation for Professionals in Regulatory Affairs

44