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.

Advice Procedures

Advice meetings usually take place within 3 to 6 months of the application. Please note that any agreement on the timing and content of an advice meeting may depend on the procedure status of the product concerned.

Pre-Advice Meetings

Pre-Advice meetings offer guidance on general regulatory key issues and requirements at an early stage of development. The procedure provides an informal exchange between experts at the responsible agency and the applicant. However, for a more comprehensive and in-depth advice the scientific advice would be the correct procedure. The offer is aimed particularly at 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
• procedural questions regarding national authorisation, the decentralised procedure, (DCP), and the mutual recognition procedure (MRP)

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 offer the opportunity to present and discuss content and procedural questions regarding a specific, upcoming centralised marketing authorisation application or a variation. The prerequisite is that the BfArM or the Paul-Ehrlich-Institut has already been appointed as rapporteur/(co-)rapporteur by the EMA. The meeting can be requested with the participation of the second authority (co-rapporteur) and the EMA. In this case, the pre-submission meeting should be applied for at the authority designated as rapporteur.

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. regulatory and data protection requirements, the provision of evidence, or 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 legal requirements.

• Special Fee Ordinance of the Federal Ministry of Health (BMGBGebV)

  • Section 3 – Medicinal Products Act (AMG), Table 1, No. 25.6, Advice: 1,000 – 18,000 EUR
  • Section 3 – Medicinal Products Act (AMG), Table 2, No. 20.1, Advice: 200 – 6,000 EUR
  • Section 9 – Medical Device Law Implementation Act (MPDG), No. 5, Advice: 500 – 10,000 EUR

• Special Fee Ordinance of the Federal Ministry of Food and Agriculture (BMELBGebV)

  • Veterinary: Section 15, Subsection 2, Number 10.1, Advice: 200 - 6,000 EUR

• Fees for DiGA and DiPA

  • Digital Health Applications Ordinance (DiGAV): 250 – 5,000 EUR
  • Digital Care Applications Ordinance (DiPAV): 250 – 5,000 EUR

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

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

Application

Please use the linked application form to apply for the above-mentioned advice procedures.