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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  Learn more about EuroGCT's Key Resources

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Showing 10 of 86
EuroGCT Resource

Manufacturing Authorisation

  • EU and UK
  • 2023
  • EuroGCT
Any company wishing to manufacture a medicinal product must hold a manufacturing authorisation issued by the national competent authority of the Member State where they carry out these activities. To obtain a manufacturing authorisation, all medicinal products for human use intended for the European Union market must be produced in accordance with EU quality standards: Good Manufacturing Practice (GMP) principles and guidelines, and the European Pharmacopeia.

Theme

  • Show all 2
  • Manufacturing Authorisation
  • Good Manufacturing Practice
EuroGCT Resource

Standard Marketing Authorisation Pathway: Centralised Procedure for ATMPs

  • EU and UK
  • 2022
  • EuroGCT
The centralised procedure allows an ATMP to be commercialised and made available to patients and healthcare professionals throughout the entire European Union on the basis of a single marketing authorisation at the European level.

Theme

  • Show all 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Human body elements for therapeutic applications

  • EU and UK
  • 2023
  • EuroGCT
Human body elements, including tissues, cells, blood and blood components can be used for therapeutic purposes in human recipients and extracorporal applications. Depending on the types of human body elements, they can be donated both or either by living or dead donors in accordance with national legislations.

Theme

  • Show all 2
  • Therapy classification
  • Not ATMPs: Human body elements for therapeutic applications
EuroGCT Resource

Market Access for ATMPs

  • EU and UK
  • 2023
  • EuroGCT
Market Access for Advanced Therapy Medicinal Products (ATMPs): centralised authorisation procedure, expediting marketing authorisation pathways, and European Medicines Agency (EMA) regulatory support schemes

Theme

  • Show all 1
  • Market access for ATMPs
EuroGCT Resource

Expediting marketing authorisation pathways

  • EU and UK
  • 2023
  • EuroGCT
Within the European Union, three legal procedures have been developed to expedite access to new medicines, including ATMPs: conditional marketing authorisation, marketing authorisation under exceptional circumstances, and accelerated assessment.

Theme

  • Show all 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

ATMPs and Orphan medicinal products

  • EU and UK
  • 2023
  • EuroGCT
Advanced therapy medicinal products (ATMPs) and orphan medicinal products. Obtaining the orphan designation gives access to financial and regulatory incentives aimed at improving the attractivity of research and development of innovative medicinal products for rare diseases. 

Theme

  • Show all 2
  • Therapy classification
  • ATMPs
EuroGCT Resource

[Poster] The challenges of Advanced Therapy Medicinal Products manufacturing in the European Union: Strengths and limits of current regulatory tools

  • EU and UK
  • 2023
  • EuroGCT
This poster provides an overview of the challenges of ATMPs’ manufacturing and link them to the relevant supporting regulatory tools highlighting both their strengths and their limits in the context of ATMPs development for patients.

Theme

  • Show all 2
  • Manufacturing Authorisation
  • Good Manufacturing Practice
EuroGCT Resource

[Poster] The marketing authorisation of advanced therapy medicinal products under the regulation of the European Union

  • EU and UK
  • 2023
  • EuroGCT
This poster presents the European regulatory requirements and pathways for ATMPs to obtain marketing authorisation, and discuss the challenges of their commercialisation.

Theme

  • Show all 2
  • ATMPs
  • Market access for ATMPs
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.

Theme

  • Show all 7
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
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.

Theme

  • Show all 5
  • Therapy classification
  • Legal classification
  • ATMPs
  • Not ATMPs: Human body elements for therapeutic applications
  • Not ATMPs: medical devices containing tissues and cells
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