Module 5 Presentations

05/07/2024

2. Clinical Trial Application initial submissions under CTR

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

13

Clinical Trial application considerations

Topic

CTR

Process

Part I (scientific dossier) / Part II (national parts) all submitted via the Clinical Trial Information System. Several submission options: All together (CTR Art.5), sequentially (Part I then Part II) or hybrid (Part I and some Part II) (CTR Art.11) Increased harmonization between MSs with alignment on core documents and more defined country exceptions to the requirements (to a degree) detailed in CTR Annexes 1 & 2 Coordinated assessment by Reference Member State (RMS) for Part I between MSs / Part II nationally assessed Unique trial decision, per country CTR mandates timelines, not the process (CA/EC involvement for Part I and/or Part II) Harmonized procedure defined by CTR. Timelines enforced by tacit approval principle once Part I concluded. Note: 12 days to answer RFIs and a default winter clock stop

Content

Evaluating bodies

Timelines

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

14