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Glossary

Adeno-associated virus (AAV)
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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 21
EuroGCT Resource

Support for innovative medicines’ development at the EMA level

  • EU and UK
  • 2023
  • EuroGCT
EMA's support for innovative medicines’ development aims to clarify the applicable regulatory requirements for the medicinal products in development. Both procedures and services support the developers through establishing best strategies as early as possible for obtaining the required data (robust quality, pre-clinical, and clinical data) for commercialising innovative medicinal products (including ATMPs) in the European Union (EU) through the applicable and most adapted regulatory pathway.
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  • Show all 3
  • Research and Innovation
  • Early interaction with regulators
  • Market access for ATMPs
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

Support specific to ATMPs’ development at EMA level

  • EU and UK
  • 2023
  • EuroGCT
Procedural support exclusively for Advanced Therapy Medicinal Products (ATMPs) at the EMA level offers incentives or an easier access to the procedures for developers of ATMPs, especially sponsors.
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  • Research and Innovation
  • Early interaction with regulators
EuroGCT Resource

Case Study: Holoclar

  • EU and UK
  • 2023
  • EuroGCT
Case Study on Holoclar: Holoclar is one of the few ATMPs that have been granted marketing authorisation in Europe. We collated existing information about each stage of development for Holoclar, from early-stage research to approval, for the research community to learn about its development process.
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  • Research and Innovation
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Funding
  • Incentives
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Commercialisation
  • Market access for ATMPs

Taking ATMPs to Market

  • UK
  • 2018
  • CGT Catapult
A presentation by Cell and Gene Catapult (CGT Catapult) on topics including: ATMP regulatory framework in EU, therapy classification, early development support by EMA (EU) and MHRA (UK), and market access pathways.
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  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Market access for ATMPs

Creating EU market access roadmaps for cell and gene therapies

  • UK
  • 2016
  • CGT Catapult
Market access roadmaps for cell and gene therapies published by Cell and Gene Therapy Catapult (CGT Catapult). Contains individual reimbursement roadmaps for UK (England and Wales), and EU countries (Spain, Italy, France, and Germany).
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  • Show all 9
  • Funding
  • 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
  • Market access for ATMPs
  • Pricing & reimbursement

New guidance on the development and marketing of ATMPs in the UK and EU in the post-BREXIT landscape

  • UK
  • 2022
  • CGT Catapult
A guidance by the Cell and Gene Therapy Catapult (CGT Catapult) on the development and marketing of ATMPs in the UK and EU in the post-BREXIT landscape.
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Theme

  • Show all 15
  • Clinical research
  • Translational Science
  • 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 Authorisation
  • Good Manufacturing Practice
  • Packaging and labelling
  • Market access for ATMPs
  • Distribution
  • Pharmacovigilance
  • Pricing & reimbursement

EMA Support for advanced therapy developers

  • EU
  • European Medicines Agency (EMA)
Advisory services and incentives the European Medicines Agency (EMA) offers for supporting the development of advanced therapy medicinal products (ATMPs).
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  • Fundamental Research
  • Clinical research
  • Incentives
  • Early interaction with regulators
  • ATMPs
  • Good Manufacturing Practice
  • Market access for ATMPs

IRDiRC Orphan Drug Development Guide

  • Global
  • IRDiRC
The Orphan Drug Development Guidebook (ODDG) by the International Rare Diseases Research Consortium (IRDiRC) is a patient focused guidebook that describes the available tools, incentives, resources and practices specific for developing traditional and innovative drugs/therapies for rare disease indications and how to best use them.
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  • Research and Innovation
  • Fundamental Research
  • Clinical research
  • Funding
  • Incentives
  • Early interaction with regulators
  • ATMPs
  • Market access for ATMPs
  • Pricing & reimbursement
  • Data
  • Data protection
  • Data storage
  • Data collection, processing, controlling
  • Data sharing / Open Data
  • Patient & Public Involvement
  • Ethics

ATMP Sweden Regulatory Guide

  • Sweden
  • ATMP Sweden
ATMP Sweden's regulatory guide for the development of the Advanced Therapy Medicinal Products (ATMPs)
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  • Show all 12
  • Fundamental Research
  • Clinical research
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
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