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The Innovation Office at the Paul-Ehrlich-Institut

Informal advice for the development of Advanced Therapy Medicinal Products (ATMP)

E-Mail: innovation@pei.de
Phone: +49 6103 77 1012
direct Link: www.pei.de/innovation-office

Major progress in biotechnology resulted in the development of advanced therapies such as gene therapy, somatic cell therapy, and tissue engineering. These developments provide new opportunities in treating serious diseases and functional disorders of the human body. Based on their novelty and complexity, special harmonised regulations have been established for so-called Advanced Therapy Medicinal Products (ATMP) at a European level.

The Innovation Office at the Paul-Ehrlich-Institut provides companies developing advanced therapies with the opportunity to receive regulatory and scientific advice. It was established as central co-ordination office for company’s questions and aims at an "all-in-one" solution in the form of co-ordinating enquiries relating to all issues as well as providing a liaison to EMA, KKS Centres, IQWIG and G-BA (Gemeinsamer Bundesausschuss, Federal Joint Committee).

Scope of advice

  • Contact for general regulatory issues for the development of ATMPs
  • Contact for the co-ordination of scientific advice
  • Contact for the German Health Research Centers "German Centre for Infection Research" (DZIF, Deutsches Zentrum für Infektionsforschung) and "German Consortium for Translational Cancer Research" (DKTK, Deutsches Konsortium für Translationale Krebsforschung)
  • Contact for a preliminary check for recognition of a European SME status at the EMA

Addressees

  • Academia, for example clinical research groups with focus on ATMPs
  • The private sector, for example small companies also spin-offs with focus on ATMPs
  • The private sector, for example medium-sized companies with focus on ATMPs

Contact

Bettina Ziegele, M. A., Head of Innovation Office
Email: innovation@pei.de
Phone: +49 6103 77 1012
Phone: +49 6103 77 1033

Regulatory advice

  • Procedural regulatory advice (Focus: Classification of the medicinal product as ATMP)
  • Advice for application procedures, for example national / European
  • Advice for further specific rules, guidelines etc.

Co-ordination of scientific advice

  • At a very early research stage of the medicinal product development
  • With respect to national authorisations
  • As a pre-evaluation before clinical trials (national advice)
  • With regard to centralised marketing authorisations
  • With regard to submissions of applications for clinical trials

Assistance / objectives

  • supporting the development of medicinal products in Germany as a location for pharmaceutical industry as early as possible
  • Providing regulatory advice for the development of innovative medicinal products for the purpose of safety and efficacy assessment.
  • Support for applicants:

    a. Support in the development of ATMPs with respect to regulatory parameters

    b. Scientific advice concerning the requirements for quality, pre-clinical and clinical data

    c. Identification of problems in the developing process of ATMPs

Examples of issues

  • Definitions of important regulatory requirements
  • Discussions of procedure: national versus European
  • Identification of a risk-based approach
  • Product development versus proof of principle in man
  • Concepts and designs of clinical trials / definition of relevant endpoints
  • Granting of certifications by the EMA

Forms

Applications for an authorisation pursuant to Section 4b AMG

Suggested forms and templates for applications for an authorisation pursuant to Section 4b, 3 AMG (Arzneimittelgesetz, German Medicines Act) for advanced therapy medicinal products (ATMP) prepared on a non-routine basis can be found here (only available in German).
Applications can also be submitted by email on AMG-EV@pei.de. For additional information on electronic submissions and encrypting options (e.g. PGP) click here.

Regulations

Laws

Statutory Regulations

GCP Regulation – online version (only available in German)

European Regulations

Laws relating to fees

Statutory cost regulation for Official Duties of the Paul-Ehrlich-Institut pursuant to the AMG (PEI-KostVO – consolidated version of 2009) – online version (only available in German)

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