Scientific, technical and regulatory advice meetings

The National Innovation Office at the FAMHP offers the possibility to request national scientific, technical and regulatory advice (STA) related to the R&D aspects of human or veterinary medicines in view of future clinical trial applications (CTAs), marketing authorisation (MA) applications, introduction of variations to marketed medicines or line extensions.

This centralised and transparent service within the FAMHP ensures the processing of the national STA requests in a timely fashion while assuring full confidentiality and avoiding potential conflict of interest of the involved experts.

For SMEs, academic research centres, spin-offs and academic hospitals, the National Innovation Office foresees specific presubmission STA assistance to guide the innovators during the preparatory phase of an STA application. More information via innovationoffice@fagg-afmps.be.

Introduction

How to apply

Regulation

Fees

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Last updated on 26/07/2017