Tasks

Scientific Advice may be provided at any time before or after the initial authorisation of the medicinal product, and may cover a variety of questions related to the planning of the development programme. For medical devices, scientific advice is offered with regards to clinical trial applications. This will be addressed through a Scientific Advice procedure.

Advice prior to Clinical Trial Application (Pre-CTA Advice) is offered for a specific clinical trial for which a CTA is planned. The ethics committee may be involved.

Advice prior to a Marketing Authorisation Application (Pre-submission Advice)  is focused on questions related to planning and conduct of a concrete, forthcoming marketing authorisation application or variation, for which the development programme is complete.

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.

Detailed information about the various advice procedures are summarised in the "Guidance for Applicants“ together with details on how to apply for advice and how these procedures are conducted. In addition, this document provides detailed guidance for filling-out the application form.

Contact

In case of questions regarding advice procedures the following contact is provided:

E-Mail: advice@bfarm.de

Telefon: +49 (0)228 99 307-3958