Overview of Advice Concepts

Pre-Advice Meeting

• Very early stage of medicinal product development
• General (scientific) guidance and regulatory orientation
• Informal exchange on general issues, e.g. a new development approach, the establishment of a new method, etc.

Scientific Advice

• Specific project/product related aspects
• Focus on quality, non-clinic and/or clinic
• Questions concerning the planning and procedure of a clinical trial
• Participation of additional agencies may be possible upon request (simultaneous advice)
• Scientific Advice involving representatives from the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA)

Portfolio Meeting

• Presentation of product pipeline
• Information regarding relevant developments in advance of an application for a clinical trial or marketing authorisation

Pre-Submission Meeting (centralised procedure)

• Meeting prior to submission of a marketing authorisation application (pre-submission meeting) or a variation
• Questions related to planning and execution of a forthcoming marketing authorisation application to be submitted in the immediate future

Advice within the framework of DKTK and DZIF

The same advice structure is offered for project initiatives of the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKTK) and the German Center for Infection Research (Deutsches Zentrum für Infektionsforschung, DZIF), i.e. pre-advice meetings are organised as kick-off meetings and scientific advice corresponds to the concepts above.

Please note that consent for the timing and content of an advice meeting may depend on the respective product procedure status.

Notes on Fees

Advice is generally subject to fees and, if applicable, additional expenses payable by the applicant. The notification on fees will be issued after completion of the procedure (which may include cases of application withdrawal or rejection after initiation of processing).

Fees will be determined based on the complexity of the request and its handling:

• Human sector
  in accordance with the provisions of the Special Fee Ordinance of the Federal Ministry of Health for individually attributable services in its area of responsibility (Special Fee Ordinance BMG - BMGBGebV), Section 3, German Medicinal Products Act, Table 2, No. 20.1,
  amount of fees for consultation: 200 to 6,000 euros
• Veterinary sector
  in accordance with the provisions of the Special Fees Ordinance of the Federal Ministry of Food and Agriculture for individually attributable public services in its area of responsibility (Special Fees Ordinance BMEL - BMELBGebV), Section 15, Subsection 2, No. 10.1,
  amount of fees for consultation: 200 to 6,000 euros

Please note that additional fees apply for the involvement of ethics committees.

No national fees are charged for consultation prior to submission of a marketing authorisation application to the European Medicines Agency (EMA), for orientation meetings and for portfolio meetings.

Pre-Advice

The Pre-Advice meetings are held in advance of Scientific Advice at the time of drug discovery. Pre-Advice provides you with very general guidance and basic orientation regarding regulatory aspects of the different medicinal product classes within the responsibility of the Paul-Ehrlich-Institut (PEI).

The aim is to prepare the way for regulatory requirements at a very early point on the drug development timeline. In this context, new therapeutic approaches or innovations during the transition from the first idea to a precise product will also be discussed with regard to possible regulatory pathways.

Please note product specific aspects or questions exceed the scope of the Pre-Advice. Those issues should be discussed in a Scientific Advice Meeting, subsequent Pre-Advice.

The Pre-Advice meeting is free of charge.

Procedure

• Informal email to: innovation@pei.de (no request form required)
• Informal information on project (1-3 pages) sent by the applicant
• Pre-Advice Meeting

Scientific Advice

Scientific Advice provides you with procedural and scientific support for medicinal products within the responsibility of the PEI. This support is offered at an early stage and in parallel to the entire process of your product development.

In the course of receiving scientific advice, you have the possibility to address individual specific product related questions, e.g. regarding the manufacturing process, quality, viral and microbiological safety aspects, pharmacokinetics, toxicology, clinical trial design, etc. with the experts from the Paul-Ehrlich-Institut (PEI).

As pharmaceutical development is expanding fast and spreading across several medicinal product areas, Scientific Advice also covers new and innovative therapies, therapeutic combinations and treatment concepts.

Procedure

Source: PEI

• Step 1: Email with request form to: innovation@pei.de
• Step 2: Briefing document sent by the applicant 3 weeks prior to the meeting (Information for preparation of briefing document and meeting minutes)
• Step 3: Scientific Advice meeting
• Step 4: PEI offers a review of the meeting minutes provided by the applicants 2-3 weeks after the meeting, which is reviewed by the PEI

Involvement and Participation of Federal State Authorities

In Germany the development of medicinal products may require additional authorisations, i.e. regarding the manufacturing process or for import. For biological medicinal products, the decisions on these authorisations are taken by the competent federal state authority in consultation with the PEI. This also applies for product classifications. Applicants seeking advice on these topics can be supported with the organisation of Scientific Advice with the participation of the competent federal state authorities.

Involvement and Participation of the BfArM

The development of new products extends across several medicinal product areas and expands to new therapeutic combinations and concepts. Scientific Advice in collaboration with the BfArM supports the development of products that are within the responsibility of the PEI but additionally contain medical devices, radioactive components, small molecules or other medicinal product areas within the responsibility of the BfArM.

PEI and G-BA

The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA), the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI) have entered into an agreement for the purpose of collaborating closely, in a structured manner and as early as possible in joint questions concerning both the marketing authorisation of medicines and the early benefit assessment of medicines in the context of health technology assessment (HTA).

The core idea of this initiative is to promote clinical trial designs generating sound evidence addressing both regulatory (marketing authorisation) and HTA-related (early benefit assessment) aspects.

For Joint Advice from PEI and G-BA addressing both regulatory and HTA-related aspects, two options are open to applicants for planning their clinical trials, depending on the focus of advice: Joint Scientific Advice (with focus on scientific and regulatory questions) at PEI and Advice pursuant to Section 35 a SGB V (Sozialgesetzbuch, German Social Code) (with a focus on Health Technology Assessment) at the G-BA.

Please note that the two types of advice are not equivalent: Joint Scientific Advice cannot be considered as equivalent to advice pursuant to Section 35 a SGB V, and advice pursuant to Section 35 a SGB V cannot replace Joint Scientific Advice at PEI.

Joint Scientific Advice by PEI with involvement of experts from the G-BA

The focus of the Joint Scientific Advice is on the scientific regulatory issues at the PEI.

Source: BfArM, PEI, G-BA

• Application: Request for Scientific Advice
• Advice type: Scientific Advice at PEI involving G-BA experts (Joint Scientific Advice)
• Minutes: Draft by the applicant with subsequent amendments from PEI and G-BA
• Fees: Fee notifications from PEI and G-BA

Contact

PEI Innovation Office
Phone: +49 (0)6103 77 2772
Email: innovation@pei.de

Advice pursuant to Section 35a SGB V at the G-BA with involvement of PEI experts

The focus of the consultation according to § 35 a SGB V is on the early benefit assessment at the G-BA.

Source: BfArM, PEI, G-BA

• Application: Application form at the G-BA
• Advice type: Advice at the G-BA involving PEI experts
• Minutes: Meeting minutes by the G-BA
• Fees: Fee notification from G-BA

Contact

Federal Joint Committee (G-BA)
Email: beratung35a@g-ba.de

Portfolio Meeting

You have the possibility to give an overview of your medicinal product range and pipeline. The meeting allows a general discussion on regulatory and procedural aspects regarding the product portfolio and subsequent development.

Procedure

• Email with short description of concerned active substances: innovation@pei.de
• Presentation send by applicant 2 weeks prior to the meeting
• Portfolio Meeting