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What is gene and cell therapy?
What are ATMPs, and where do they fit into gene and cell therapy?
Why are animal models used when testing the safety of a new therapy?
What role do preclinical and clinical trials play in ensuring patient safety?
Why are some conditions more suitable for gene and cell therapies than others?
There is an approved treatment available for my condition - why can't I receive it?
How to look for approved medicines?
How are medicines developed and approved?

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Research Pathways

Bringing gene and cell therapies from the lab bench to patients is a complex process and multiple pathways exists. The Research Pathways directory contains resources to help various stakeholders interested in therapy development navigate this process. Research Pathways is centred around the legal and regulatory aspects for cell and gene therapy development in Europe and further expanded to additional aspects. It is free to use and all resources in this database are categorised for improved searchability.

How to use Research Pathways  EuroGCT's Key Resources

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Showing 10 of 91
EuroGCT Resource

Case Study: Early therapy classification considerations in developing skin equivalents

  • EU and UK
  • 2024
  • EuroGCT
How a therapy is developed and produced can affect its classification and determines the legal mechanisms that govern its regulation. In the case of developing skin equivalents for healing skin wounds, choices of preparation steps results in different therapy classification.
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  • Show all 10
  • Fundamental Research
  • Clinical research
  • Incentives
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Not ATMPs: Human body elements for therapeutic applications
  • Good Manufacturing Practice
  • Market access for ATMPs
  • Pharmacovigilance
EuroGCT Resource

Therapy Classification

  • EU and UK
  • 2022
  • EuroGCT
Therapy classification determines the legal mechanisms that govern the regulation of gene and cell therapies to ensure the quality, safety, and efficacy of these therapies on the EU market.
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  • Show all 5
  • Therapy classification
  • Legal classification
  • ATMPs
  • Not ATMPs: Human body elements for therapeutic applications
  • Not ATMPs: medical devices containing tissues and cells
EuroGCT Resource

Commercialisation

  • EU and UK
  • 2022
  • EuroGCT
Enabling timely patient access to Advanced Therapy Medicinal Products (ATMPs), commercialisation covers marketing authorisation, and post-authorisation activities such as pharmacovigilance, pricing and reimbursement.
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  • Commercialisation
  • Market access for ATMPs
  • Distribution
  • Advertising
  • Pharmacovigilance
  • Pricing & reimbursement
EuroGCT Resource

Marketing Authorisation under exceptional circumstances for ATMPs

  • EU and UK
  • 2023
  • EuroGCT
To facilitate early patient access to medicinal products, marketing authorisation (MA) can be granted through specific regulatory mechanisms offered by European Union law. A marketing authorisation under exceptional circumstances for medicinal products may be granted when the applicant is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because the indication to be treated is too rare, the present state of scientific knowledge is insufficient to provide comprehensive information, or it would be unethical to collect this information.
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  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Advertising of ATMPs

  • EU and UK
  • 2023
  • EuroGCT
Advertising of medicinal products, including ATMPs, is mainly regulated by National laws apart from minimum binding requirements established by EU Law.
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  • Commercialisation
  • Advertising

ATMP Legal Framework

  • EU
  • EMA
This page from the European Medicines Agency (EMA) website lists the legal frameworks applicable for ATMPs.
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  • Research and Innovation
  • Clinical research
  • Incentives
  • Early interaction with regulators
  • Therapy classification
  • Legal classification
  • ATMPs
  • Not ATMPs: Human body elements for therapeutic applications
  • Not ATMPs: medical devices containing tissues and cells
  • Manufacturing
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Commercialisation
  • Market access for ATMPs
  • Pharmacovigilance
  • Data
  • Data protection
  • Data collection, processing, controlling

The EU CAR-T Handbook

  • EU
  • 2025
  • EBMT, EHA and GoCART Coalition
This second edition CAR-T Handbook published by the European Society for Blood and Marrow Transplantation (EBMT), the European Hematology Association (EHA) and the GoCART Coalition, provides a comprehensive, open-access resource covering the latest developments in CAR-T cell therapies.
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  • Clinical research
  • Translational Science
  • Therapy classification
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs
  • Pharmacovigilance
  • Data
  • Data collection, processing, controlling
EuroGCT Resource

Research and Innovation

  • EU and UK
  • 2022
  • EuroGCT
The development of innovative therapies starts with translating discoveries from basic research. This section explores the steps from fundamental to pre-clinical and clinical research underpinning the development of innovative gene and cell therapies.
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  • Research and Innovation
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Funding
  • Incentives
  • Early interaction with regulators
EuroGCT Resource

Manufacturing

  • EU and UK
  • 2022
  • EuroGCT
Advanced therapy medicinal products (ATMP) manufacturing concerns the industry-scale production of these therapies for supporting clinical development and commercialisation. This section provides an overview of the ATMP manufacturing processes, key terms, and related resources.
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  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling

ATMP guidebook

  • Netherlands
  • 2025
  • FAST
The ATMP guidebook published by the Centre for Future Affordable & Sustainable Therapy Development (FAST) in Netherlands delivers essential guidance on European and Dutch regulations and provides a roadmap to navigate the complex ATMP development process.
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  • Show all 17
  • Research and Innovation
  • Fundamental Research
  • Clinical research
  • Incentives
  • Early interaction with regulators
  • Therapy classification
  • Legal classification
  • ATMPs
  • Good Manufacturing Practice
  • Commercialisation
  • Market access for ATMPs
  • Distribution
  • Pharmacovigilance
  • Pricing & reimbursement
  • Data
  • Data protection
  • Patient & Public Involvement
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