Research Pathways

Bringing therapies from the lab bench to patients is a complex process. We are developing our own as well as signposting to existing resources to help guide researchers and those interested in therapy development through this process. 

The Research Pathways is centred around the legal and regulatory aspects that are required for cell and gene therapy development in Europe, from binding law, non-binding guidelines and recommendations, then further expanded to additional aspects including scientific developments, health economics and more. 

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More ways to navigate Research Pathways

Key Pathways Resources

Signposting to key resources on ATMP development

Case Studies

Learn from specific development cases and relevant resources

Patient and Public Involvement

ATMP Engage Patient and Public Involvement Directory

Actors & Networks

Mapping the stakeholders in Europe and beyond

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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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  • Research and Innovation
  • Early interaction with regulators
  • Market access for 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.
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  • 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.
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  • 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.
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  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Conditional Marketing Authorisation of 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. When an Advanced Therapy Medicinal Product (ATMP) addresses an unmet medical need of patients, a conditional marketing authorisation may be granted on the basis of less comprehensive data than usually required.
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  • Commercialisation
  • Market access for ATMPs
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

Accelerated Assessment of 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. The accelerated assessment is a procedural tool to reduce the centralised procedure review period of a marketing authorisation applicant. An applicant may request an accelerated assessment for medicinal products if they are of major public health interest, in particular from the viewpoint of therapeutic innovation.
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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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Theme

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  • Commercialisation
  • Advertising
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.  
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  • Packaging and labelling

The EBMT Handbook

  • EU
  • 2019
  • EBMT
The EBMT Handbook published by the European Society for Blood and Marrow Transplantation (EBMT) addresses the latest developments and innovations in haematopoietic stem cell transplantation (HSCT) and cellular therapy. It discusses all types of stem cell and bone marrow transplantation, including haplo-identical stem cell and cord blood transplantation, and also covers the indications for transplantation, the management of early and late complications as well as the new and rapidly evolving field of cellular therapies.
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  • Fundamental Research
  • Clinical research
  • Ethics
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