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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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More ways to navigate Research Pathways

Showing 10 of 91

ATMP Legal Framework

  • EU
  • EMA
This page from the European Medicines Agency (EMA) website lists the legal frameworks applicable for ATMPs.

Theme

  • Show all 18
  • 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

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.

Theme

  • 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

Academic development of ATMPS in Belgium

  • Belgium
  • 2024
  • Belgian Health Care Knowledge Centre (KCE)
A Report published by the Belgian Health Care Knowledge Centre (KCE) on academically developed ATMPs in Belgium.

Theme

  • Show all 13
  • Research and Innovation
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Funding
  • Incentives
  • ATMPs
  • Manufacturing
  • Good Manufacturing Practice
  • Scalability
  • Commercialisation
  • Market access for ATMPs
  • Pricing & reimbursement
EuroGCT Resource

Packaging and labelling of ATMPs

  • EU and UK
  • 2022
  • EuroGCT
Packaging and labelling (including outer packaging, the immediate packaging and the package leaflet) provide the information on an advanced therapy medicinal product (ATMP) to patients.  

Theme

  • Show all 1
  • Packaging and labelling
EuroGCT Resource

Good Manufacturing Practice for ATMPs

  • EU and UK
  • 2023
  • EuroGCT
Good Manufacturing Practice (GMP) is a code of quality standards concerning the manufacture, processing, packing, release and holding of a medicinal product placed within the European Economic Area (EEA). GMP describes the minimum standard that a medicines manufacturer must meet in their production and quality control processes, including those involving medicinal products intended for export only and medicines and active substances imported into the EU.

Theme

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

ATMPs and Orphan medicines

  • 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

Specificities of the marketing authorisation dossier for biosimilar ATMPs

  • EU and UK
  • 2023
  • EuroGCT
EU's biosimilar pathway increases patients’ access to safe and effective Advanced Therapy Medicinal Products (ATMPs) at a lower cost compared to the existing reference medicinal products which have lost their exclusivity rights. The applicant for a biosimilar marketing authorisation has to demonstrate in a simplified dossier high similarity of the biosimilar to the reference medicinal product in terms of quality and clinical aspects.

Theme

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

Marketing Authorisation Application file for ATMPs

  • EU and UK
  • 2022
  • EuroGCT
Marketing authorisation application requires from the applicant the submission of a file containing documentation and data related to the medicinal product to be authorised. The file must comply with the Common Technical Document (CTD), a set of specifications for the marketing authorisation application dossier. Under the centralised procedure the application is submitted under a standardised electronic format, the electronic Common Technical Document (eCTD), through an online portal.

Theme

  • Show all 2
  • Commercialisation
  • Market access for ATMPs
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

Mission creep / Data misuse

  • EU and UK
  • 2023
  • Brunel University London and EuroGCT
Mission creep or data misuse is focused on the legitimacy and purposes for which patient data is collected, used, stored, and processed.

Theme

  • Show all 2
  • Data
  • Mission creep / data misuse
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