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.

Advice Procedures

All advice procedures listed must be applied for via the link below. Advice usually take place within 3 to 6 months after application.

Pre-Advice Meeting

Pre-Advice meetings offer guidance on general regulatory key issues and requirements at an early stage of development. Such meetings are provided in particular for academic research groups and start-ups.

Scientifc Advice

Scientific Advice allows a more in-depth discussion of specific questions regarding national applications and marketing authorisation procedures for medicinal products that are within the remit of the BfArM.

Questions regarding the planned approval or amendment of clinical trials or regarding (initial or existing) marketing authorisations can include the following topics:.

• pharmaceutical quality
• non-clinical studies
• clinical trials (including biostatistics as well as questions regarding ethical aspects with the involvement of Ethics Committees)
• pharmacovigilance
• procedural issues for DCPs or MRPs

For medical devices, scientific advice is offered prior to submitting an application for approval of a clinical trial.

Pre-Submission Meeting (centralised procedure)

Pre-Submission meetings focused on questions related to content and conduct of a specific, forthcoming centralised marketing authorisation application or variation, for which the development programme is complete and BfArM is assigned as rapporteur/co-rapporteur. These meetings can be held as joint meetings with both rapporteurs and EMA.

Portfolio Meeting

Portfolio meetings provide the opportunity for pharmaceutical companies to present an overview of different ongoing product developments. This will also allow an exchange on pipeline-relevant overarching regulatory aspects.

Advice Regarding Digital Applications

The advice regarding digital applications is aimed at developers and manufacturers of DiGA and DiPA and offers comprehensive support and guidance on various topics, e.g. explaining regulatory and data protection requirements, or on the provision of evidence, or on study design.

Please note, that the authorities’ consent to an advice meeting (in terms of content and timing) may depend on the respective processing status of the product.

Payment of Fees

Advice procedures are generally subject to fees and - if applicable - additional expenses payable by the applicant. The notification of fees will be issued after completion of the procedure (where appropriate also in case of withdrawal of the application or rejection after initiation of processing). The fee will be determined based on the complexity of the request and its handling by the Institutes in accordance with the Ministry of Health’s Fee Ordinance – BMGBGebV:

• Section 3 – Medicinal Products Act (AMG), Table 1, No. 25.6, Advice: 1,000 – 18,000 euros
• Section 3 – Medicinal Products Act (AMG), Table 2, No. 20.1, Advice: 200 – 6,000 euros
• Section 9 – Medical Device Law Implementation Act (MPDG), No. 5, Advice: 500 – 10,000 euros
• Veterinary: BMEL- BMELBGebV, Section 15, sub-section 2, number 10.1, Advice: 200 - 6,000 euros
• DiGAV: 250 – 5,000 euros
• DiPAV: 250 – 5,000 euros

Please note, that additional fees can be charged by the Ethics Committee, if it is involved.

There are no national fees for Pre-Submission Meeetings (centralised procedure), Pre-Advice Meetings, and Portfolio Meetings.

Application form

For all listed advice procedures, an advice application must be submitted via the application form.

Supporting informations

• Formal requirements – briefing document and meeting minutes

Scientific Advice, Pre-Submission Meeting (centralised procedure), Portfolio Meeting

• Guidance for Applicants for scientific advice, pre-submission meetings (centrailised procedure) or portfolio meeting
• Example briefing document
• Example meeting minutes
• Example List of questions

Pre-Advice Meeting, DiGA/DiPA-Advice

• Guidance for Applicants for orientation meetings or DiGA/DiPA consulations
• Example briefing document (DiGA)
• Example briefing document (DiPA)
• List of questions (DiGA/DiPA)

Contact

If you have any questions regarding the different avice procedures, you may use the following email addresses or telephone numbers.

Pre-Adivce Meeting, DiGA/DiPA-Advice through the Innovation Office:
E-Mail: innovation@bfarm.de
Phone: +49 (0) 228 99 307 - 4053

Scientific Advice Meeting, Pre-Submission Meeting (centralised procedure), Portfolio Meeting:
E-Mail: advice@bfarm.de
Phone: +49 (0) 228 99 307 - 3958