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Actors and Networks database

The evolving field of gene and cell therapy is supported by a large community of academic, clinical, translational, regulatory and patient organisations. The Actors and Networks database maps these stakeholders in Europe and beyond, their activities, and resources they have produced. 

EuroGCT has developed and compiled this database for those interested in identifying the actors involved at each stage of the pathways bringing gene and cell therapies from lab to clinic. Coming from an academic perspective, our focus is to map information that has not been mapped elsewhere. This includes documenting the various types of interconnected regulators, patient groups actively involved along the pathways, and non-profit organisations devoted to therapy development. In its first iteration, this database does not yet include commercial partners and service providers.

Additional complementary work by other organisations on GCT stakeholders mapping can be found here.

A scientific paper on actors has also been published in Humanities and Social Sciences Communications. You can find its lay summary here.

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Medical Device Coordination Group Working Groups (MDCG)

Type of Actor:

  • Regulators
  • Medical Devices Entities
  • Medical Device Authorities
  • Supranational Medical Device Authorities

Development Stage:

  • Clinical Research
  • Manufacturing
  • Commercialisation

Member State Coordination Group on HTA (HTACG)

Type of Actor:

  • Regulators
  • HTA Bodies
  • Payers

Development Stage:

  • Commercialisation

Additional information

The Member State Coordination Group on Health Technology Assessment (‘HTA Coordination Group’), is made up of representatives from the Member States (in particular from health technology assessment authorities and bodies). From 1 January 2025, it is responsible for ATMPs’ joint clinical assessments (sub-group for this purpose) that will inform National decisions’ subsequent decisions on pricing and reimbursement.

Ministry of Health of the Czech Republic (Ministerstvo zdravotnictví) (MZCR)

Region/Country:  
  • Countries in the EU/EEA
  • Czechia

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for Tissues and Cells
  • Competent Authorities for Blood and Blood Components

Development Stage:

  • Fundamental Research
  • Translational Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The Ministry of Health of the Czech Republic is the competent authority for tissues and cells and for blood and blood components in the Czech Republic.

Ministry of Health of the Republic of Croatia (Ministarstvo zdravstva Republike Hrvatske)

Region/Country:  
  • Countries in the EU/EEA
  • Croatia

Type of Actor:

  • Regulators
  • HTA Bodies
  • Medical Devices Entities
  • Medical Device Authorities
  • National Medical Device Authorities
  • Other National competent authorities
  • Competent Authorities for Tissues and Cells
  • Competent Authorities for Blood and Blood Components
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Translational Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The Ministry of Health of the Republic of Croatia is the ministry in the Government of Croatia which is in charge of healthcare and welfare. It is also the competent authority for tissues and cells, and for blood and blood components.

Ministry of the Environment of the Czech Republic (Ministerstvo životního prostředí)

Region/Country:  
  • Countries in the EU/EEA
  • Czechia

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

MRC Human Genetics Unit, The University of Edinburgh (MRC Human Genetics Unit)

Region/Country:  
  • UK

Type of Actor:

  • Non-profit Research Organisations
  • Academic Bodies

Development Stage:

  • Fundamental Research
  • Clinical Research

Additional information

The MRC Human Genetics Unit combines the latest computational and experimental technologies to investigate how human genomes work to control the function of molecules, cells and tissues in people and populations.

MTIC InterCert S.r.l.

Region/Country:  
  • Countries in the EU/EEA
  • Italy

Type of Actor:

  • Regulators
  • Medical Devices Entities
  • Notified Bodies

Development Stage:

  • Manufacturing
  • Commercialisation

National Authority of Medicines and Medical Devices of Romania (Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România) (NAMMDR / ANMDMR)

Region/Country:  
  • Countries in the EU/EEA
  • Romania
Website:  

Type of Actor:

  • Regulators
  • HTA Bodies
  • Medicines Agencies
  • National Medicines Agencies
  • Medical Devices Entities
  • Medical Device Authorities
  • National Medical Device Authorities
  • Other National competent authorities
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

National Network of Structures in charge of Animal Welfare (Réseau national des structures en charge du bien-être des animaux) (National Network SBEA / Réseau National SBEA)

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for Animals

Development Stage:

  • Fundamental Research

Additional information

The National Network of Structures in charge of Animal Welfare (Réseau national des structures en charge du bien-être des animaux) is a coordinating body that brings together the structures responsible for animal welfare (Structures en charge du Bien-Être des Animaux – SBEA) within establishments that use animals for scientific purposes. Its aim is to encourage the exchange of experience and best practice between these bodies in order to improve the way animal welfare is taken into account in experimentation. It ensures that ethical principles such as the 3Rs (Replacement, Reduction, Refinement) are applied and supports establishments in complying with current regulations. Working with the relevant authorities and ethics committees, it contributes to better monitoring of the conditions in which animals are housed and used, while promoting the use of alternative approaches.

Resources

Institutional framework for the ethical supervision and protection of animals used for scientific purposes in France, including a complete organisational chart (In French): https://www.sbea-c2ea.fr/lanimal-dans-la-recherche/

National Standards Authority of Ireland (NSAI)

Region/Country:  
  • Countries in the EU/EEA
  • Ireland

Type of Actor:

  • Regulators
  • Medical Devices Entities
  • Notified Bodies

Development Stage:

  • Manufacturing
  • Commercialisation
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