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Aperçu des voies de développement

Bringing gene and cell therapies from the lab bench to patients is a complex process.The Research Pathways directory contains resources to help guide various stakeholders 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, guidelines and recommendations, then further expanded to additional aspects including ethics, scientific developments, commercialisation, health economics and more. 

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Showing 10 of 13
EuroGCT Resource

Procédure centralisée pour les médicaments de thérapie innovante

  • 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

  • Tout afficher 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Autorisation de fabrication des médicaments de thérapie innovante

  • 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

  • Tout afficher 2
  • Manufacturing Authorisation
  • Good Manufacturing Practice
EuroGCT Resource

Emballage et étiquetage des médicaments de thérapie innovante

  • 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

  • Tout afficher 1
  • Packaging and labelling
EuroGCT Resource

Commercialisation

  • EU and UK
  • 2022
  • EuroGCT
Enabling timely patient access to Advanced Therapy Medicinal Products (ATMPs), commercialisation covers marketing authorisation, and post-authorisation activities such as pharmacovigilance, pricing and reimbursement.

Theme

  • Tout afficher 6
  • Commercialisation
  • Market access for ATMPs
  • Distribution
  • Advertising
  • Pharmacovigilance
  • Pricing & reimbursement
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

  • Tout afficher 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

  • Tout afficher 5
  • Therapy classification
  • Legal classification
  • ATMPs
  • Not ATMPs: Human body elements for therapeutic applications
  • Not ATMPs: medical devices containing tissues and cells
EuroGCT Resource

Procédure d’évaluation accélérée des médicaments de thérapie innovante

  • 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

  • Tout afficher 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Autorisation de mise sur le marché sous circonstances exceptionnelles des médicaments de thérapie innovante

  • 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

  • Tout afficher 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Autorisation de mise sur le marché conditionnelle des médicaments de thérapie innovante

  • 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

  • Tout afficher 2
  • Commercialisation
  • Market access for ATMPs
EuroGCT Resource

Dossier de demande d'autorisation de mise sur le marché

  • 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

  • Tout afficher 2
  • Commercialisation
  • Market access for ATMPs
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