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. So-called "kick-off meetings" are held by the Innovation Office in order to offer support during the early development phases of medicinal products and medical devices.

We offer support for a wide range of topics, like issues regarding general understanding as well as specific questions on your individual project idea. We support you in finding the right contact person, not only within the BfArM, but also outside of the BfArM, in case your concern is not within our area of responsibility.

We make sure that the development of digital health and nursing applications proceeds without any unnecessary delay and in compliance with regulatory requirements - from a project idea up to the prescription by physicians and their safe application. With the BfArM's support, developers can take the next steps in their projects in a confident and well-advised manner. 

Contact
E-Mail: innovation@bfarm.de
Phone: +49 (0)228 99 307-4053
Service times 9.00 am - 2.00 pm (Monday to Friday)

Types of advice

The following types of advice are available:

• Kick-off Meeting, DiGA and DiPA advice
  Realised by: innovation@bfarm.de Phone: +49 (0)228 99 307-4053
• Scientific advice and pre-submission meetings and Portfolio meetings
  Realised by: advice@bfarm.de Phone: +49 (0)228 99 307-3958
  More information see Advice Procedures.

To best prepare for your kick-off meeting or DiGA/DiPA consultation, we recommend you take a look at the Guidance for Applicants.

Kick-off meeting         

Kick-off meetings are intended to impart general, orienting and regulatory information during the early development phases of medicinal products and medical devices.

Folgende Unterlagen sind für ein Kick-off Meeting einzureichen:

• application form

• Briefing document (approx. 10 pages) containing:

  • Project and product summary
  • Topics
  • Background information
  • Please indicate all your questions in Part D
• Presentation as the basis for the meeting and the questions from the application form (Part D)

DiGA Advice

DiGA advice includes assistance in basic questions of understanding that are not answered by the BfArM guides or by further information e.g. from the Ministry of Health, in technical details or questions about the evidence that needs to be provided. When planning your consultation appointment, please consider that due to the high demand we have a lead time of 3-6 months. Many answers can be found in the DiGA Guide and the DiGA webinar series (in German language only).

The following documents must be submitted for a DiGA consultation:

1. application form
2. List of questions (new!)
3. Briefing document (approx. 15-20 pages)
   • Proposal/Example: Structure of briefing document
4. Presentation

The documents under points 2-4 can be delivered up to four weeks before the consultation appointment at the latest. The list of questions will replace the current protocol template with immediate effect. For more information please check out the "Guidance for Applicants".

DiPA-Advice

DiPA advice includes assistance in basic questions of understanding that are not answered by the BfArM guides or by further information e.g. from the Ministry of Health, in technical details or questions about the evidence that needs to be provided. Many answers can be found in the DiPA guide.

1. application form
2. List of questions (new!)
3. Briefing document (approx. 15-20 pages)
   • Proposal/Example: Structure of briefing document
4. Presentation

The documents under points 2-4 can be delivered up to four weeks before the consultation appointment at the latest. The list of questions will replace the current protocol template with immediate effect. For more information please check out the "Guidance for Applicants".

Important information

FAQ Innovation Office