New revision to EMA Guidance documents released
New revision to EMA Guidance documents released
Regulatory Affairs In Vitro Diagnostics
Monday, 27 January 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On December 17th, 2024, the European Medicines Agency (EMA) released a revision of 2 guidance documents on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies, designated under Regulation (EU) 2017/746 (IVDR).
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Both documents, Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics and Questions & Answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies were updated due to the new Regulation (EC) 2024/568 on fees and charges payable to the EMA (from 1 January 2025). These documents are intended to provide the relevant parties, in particular notified bodies, device manufacturers, and medicinal product applicants, with information on the consultation procedure to the EMA by a notified body on a companion diagnostic (CDx).
What is updated in EMA/198592/2022 Rev.1 and EMA/619893/2022 Rev.1:
In the Guidance on the procedural aspects, the section on fees has been updated, now referring to the applicable EMA webpage as well as to a guide for small and medium-sized enterprises regarding fee reductions. Similar changes have been made in the Q&A document.
What does it mean to you?
Although the consultation procedure is part of the notified body’s conformity assessment of a CDx, EMA/198592/2022 Rev.1 and EMA/619893/2022 Rev.1 are of interest for manufacturers and consultants to understand the initial consultation procedure and possible follow-up consultations in case of substantial changes to the CDx. The fees to be paid are charged to the IVD manufacturer as part of the conformity assessment fee.
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