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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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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

Good Manufacturing Practice

  • 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

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.

Theme

  • Show all 2
  • 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.

Theme

  • Show all 2
  • 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.

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

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.

Theme

  • Show all 2
  • 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.  

Theme

  • Show all 1
  • Packaging and labelling
EuroGCT Resource

Translational Science

  • EU and UK
  • 2023
  • EuroGCT
Translational science translates basic science discoveries into therapeutic applications.

Theme

  • Show all 2
  • Research and Innovation
  • Translational Science
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.

Theme

  • Show all 3
  • Research and Innovation
  • Early interaction with regulators
  • Market access for ATMPs
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