The Innovation Office has been founded to support life sciences innovators in academia and industry. We provide two platforms for basic guidance on regulatory and scientific issues related to medicinal products. Our goal is to provide easier access to the regulatory and scientific expertise of Fimea.
Informal regulatory guidance
Informal regulatory guidance is a platform for change of views between authorities and drug developers and innovators who are not yet fully aware of the regulatory requirements or guidelines. Innovators at an early stage of drug development may benefit from this kind of discussions which are provided free of charge. The goal for the informal regulatory guidance process is also to establish contacts and networking with the other European innovation offices of national competent authorities (EU Innovation Network) and local stakeholders, including public investors.
Formal scientific advice is primarily meant for more advanced drug development programs. It answers the targeted questions on study design and questions for which the regulatory guidelines are not yet available. It can also assist in cases where the company wants to diverge from the established guidelines. FIMEA anwers questions regarding development of medical products based on the applicant’s documentation. Advice may be requested for all medicinal products, irrespective of subsequent choice of procedure for approval.
If you have questions regarding the Innovation Office, or if we can provide assistance, please let us know at firstname.lastname@example.org.