The development of new medicinal products and medical devices, including the monitoring of these products, is subject to complex regulatory and scientific requirements. Within the scope of their competence, BfArM and Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, provide support through various advice procedures.

Types of Advice

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

Pre-Advice Meetings

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 Meetings

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 Paul-Ehrlich-Institut or 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

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 or the Paul-Ehrlich-Institut is assigned as (co-)rapporteur. These meetings can be held as joint meetings with rapporteur/co-rapporteur and EMA.

Portfolio Meetings

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 EMA Pre-Submission, Pre-Advice, and Portfolio meetings.