The development of new medicinal products and medical devices including the monitoring of these products are subject to complex regulatory and scientific requirements. Within the scope of its competence, the BfArM provides support through various advice procedures.

Kick-off Meeting through the Innovation OfficeKick-off Meeting Innovation Office

The Innovation Office is a first point of contact for providing orientation and support, especially for academic research groups, small and medium-sized enterprises and start-ups.

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Scientific Advice and Pre-submission Meeting

Within the framework of scientific and procedural advice, specific questions concerning the development and authorisation of medicinal products and medical devices can be discussed with the BfArM. Applicants are given the opportunity to discuss questions relating to administrative procedures for which the BfArM is responsible as the approval or supervisory authority.

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Joint Advice through the BfArM and the G-BAJoint Advice BfArM and G-BA

In accordance with section 35a para. 7 of the SGB V, the BfArM can be involved in consultation procedures of the G-BA for early benefit assessment in accordance with section 35a SGB V before the start of phase three approval studies or for the planning of clinical trials.

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Procedure and fees

Advice through the BfArM needs to be applied for in writing and is subject to fees with the exception of the Portfolio Meetings.

Detailed information is summarized in the respective Guidance for Applicants. In addition, these documents provide details on how to apply for advice and how these procedures are conducted as well as detailed guidance for filling-out the application form.