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Advice Procedures

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 Meetings through the innovation office at the BfArM
Projects with an innovative approach frequently emerge from small research facilities or start-ups. Such institutions in general are less familiar with the regulatory requirements or administrative procedures regarding the development and market access of medicinal products or medical devices. Within the scope of a Kick-off Meeting, relevant aspects regarding mandatory regulatory requirements and essential procedural steps or available opportunities can be identified and discussed with the BfArM at a very early stage of the product development.

Scientific Advice and Pre-submission Meetings
The objective of Scientific and Pre-submission Advice procedures is to discuss with the BfArM regulatory and scientific matters regarding the development and licensing of medicinal products and medical devices. In this context applicants have the opportunity to obtain input with regard to questions related to administrative procedures which are in the remit of the BfArM as competent authority.

Portfolio Meetings
Furthermore, the BfArM offers so called Portfolio Meetings. These meetings provide the opportunity for pharmaceutical companies to present an overview of different development projects to the BfArM and to discuss broader and more general regulatory issues.

Joint Advice through the BfArM and the Federal Joint Committee (G-BA)
According to the German Social Code Book V section § 35a paragraph 7, a consultation through the G-BA before the start of phase 3 authorization studies should involve the BfArM.
Conversely, upon request experts from the G-BA can be involved in the consultation meeting at the BfArM.

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.

The following websites provide more information about the various advice procedures. Furthermore, 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.

In case of questions related to the various advice procedures the following contact is provided:

Kick-off Meeting through the innovation office at the BfArM:
Telefon: +49 (0)228 99 307-4053

Scientific Advice and Pre-submission Meeting, Portfolio Meetings:
Telefon: +49 (0)228 99 307-3958