Overview

The Paul-Ehrlich-Institut (PEI) provides you with a stepwise concept based on your requirements and the developmental stage of your project.

Source: PEI

Pre-Advice

• Very early stage of development
• General (scientific) guidance and regulatory orientation
• Informal exchange on general issues with regard to the medicinal product class

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 further agencies may be possible (simultaneous advice)

Joint Scientific Advice

• Liaising with the Federal Joint Committee (G-BA)
• Questions concerning authorisation and benefit assessment
• Focus on scientific and regulatory questions

Portfolio Meeting

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

In general the advice must not concern decisions from finalized procedures, pending applications or ongoing legal proceedings.

The costs can be found in the cost regulation of the Paul-Ehrlich-Institut (Section 8 (2)). Depending on time and effort, the fee is on average between 2000-4000 € per Scientific Advice. Fees may vary in isolated cases.

Advice within the framework of DKTK and DZIF

For the project initiatives DKTK and DZIF, the same advice structure applies, i.e. Pre-Advice organized as Kick-off meeting and Scientific Advice is within the regular scope.

Pre-Ad­vice

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

The aim is to prepare the way for regulatory requirements at a very early time point in drug development. In this context, new therapeutic approaches or innovations in 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

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

Here, 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.

As pharmaceutical development is expanding fast and spreading across several medicinal product areas, the 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 the import. For biological medicinal products, the decisions on these authorisations are taken by the Competent Laender Authority (federal state) in consultation with the PEI. This also applies for product classifications. To support applicants seeking advice on these topics a Scientific Advice with participation of the responsible federal state authorities can be organized.

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. The Scientific Advice in collaboration with the BfArM supports the development of products, which 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.

Bi-na­tion­al Sci­en­tif­ic Ad­vice

As part of a pilot project, we offer a simultaneous bi-national scientific advice together with further national medicine authorities in Europe.

Upon request, we take over the central coordination of appointments as well as the content-related coordination for the in-house consultations and connects the other authorities by telephone conference. Conversely, the PEI takes part in appointments by phone with other European pharmaceutical authorities.

On the basis of one submitted set of questions/data you will receive advice and recommendations from both authorities at the same point in time.

Although before and after the advice meeting an exchange of both authorities is foreseen (e.g. in relation to the minutes document), a harmonization of potential divergent positions is not mandatory.

For the participating authorities, fees and further potential legal obligations will remain unchanged.

For information regarding to the participating authorities and further procedural details, please note the guidance document below.

How to apply

Please send an Email with the filled-out request to innovation@pei.de, including the name of the authority (participating in the pilot) you wish to include.

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 marketing authorisation of medicines, on the one hand, and early benefit assessment of medicines in the context of health technology assessment (HTA), on the other.

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