Spring Intro 2023

16/02/2023

Strategic Planning for a CTA: Study Considerations

Has the Regulatory Authority already approved a previous version of the IMPD? IB? Can you refer to them in your submission?

What is standard of care, acceptability of marketed comparators?

What are the study specifics? Study Phase? First in class? Therapy Area? New formulation?

What information

Sufficient stability data? Does your data support proposed duration of treatment? And patient populations?

already exists?

Preventing Common Agency Qs - Use intelligence/observe trends to improve the quality of core documents

What Regional and Local Knowledge do you have? - Country requirements & Timelines? - Use of VHP? - Previous submission experience in countries

Refer to relevant Guidance: CTFG guidance (2014) - Contraceptive language & CTFG

Q&A Document (2017&2018) - Reference safety information

!Ease the review process for assessors!

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What was VHP?

Harmonised Scientific Assessment

Voluntary process! Not all MSs were involved

ONE consolidated set of questions

RMS led the review of the single scientific dossier for all selected EU-MSs

Predictable timelines and framework

Review timeline: 75-95

Substantial amendments can be managed via VHP Additional countries possible once initial submission is completed – reduced timeline for add MSs

VHP+ to include some Ecs

No possibility to negotiate with MSs directly

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