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Actors and Network 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.

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Czechia State Institute for Drug Control (SUKL)

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

Type of Actor:

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

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The Czechia State Institute for Drug Control is a Czech government agency responsible for regulation of the safe production of pharmaceuticals in the country, clinical evaluation of medicines and for monitoring the advertising and marketing of both medicines and medical devices.

Danish Medicines Agency (DKMA)

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

Type of Actor:

  • Regulators
  • Medicines Agencies
  • National Medicines Agencies
  • Medical Devices Entities
  • Medical Device Authorities
  • National Medical Device Authorities
  • HTA Bodies

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The Danish Medicines Agency authorises and inspects pharmaceutical companies and licenses medicinal products in the Danish market.

Danish Patient Safety Authority (STPS)

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

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
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The Danish Patient Safety Authority is the competent authority for tissues and cells and for blood and blood components in Denmark.

Estonia State Agency of Medicines

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

Type of Actor:

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

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The Estonia State Agency of Medicines is a governmental body under the Ministry of Social Affairs. Its main responsibility is the protection and promotion of public and animal health, through the supervision of medicines for human and veterinary use.

European Joint Programme on Rare Diseases (EJP RD)

Region/Country:  
  • EU/EEA

Type of Actor:

  • Networks
  • EU Research Projects
  • Training Providers
  • Medicines Research and Development
  • Patient Involvement

Development Stage:

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

Conditions and Diseases:

  • Rare diseases

Additional information

Bringing over 130 institutions from 35 countries, EJP RD aims to create an effective, comprehensive, and sustainable rare diseases research ecosystem.

European Medicines Agency (EMA)

Region/Country:  
  • EU/EEA

Type of Actor:

  • Regulators
  • Medicines Agencies
  • Supranational Medicines Agencies

Development Stage:

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

Additional information

EMA is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

European Network of Research Ethics Committees (EUREC)

Region/Country:  
  • EU/EEA

Type of Actor:

  • Regulators
  • Ethics Committees
  • Supranational Ethics Bodies

Development Stage:

  • Fundamental Research
  • Clinical Research

Additional information

EUREC is a network that brings together already existing national Research Ethics Committees (RECs) associations, networks or comparable initiatives on the European level.

Resources

National associations or national bodies of Research Ethics Committees can be found at: http://www.eurecnet.org/information/index.html

European Patients' Forum (EPF)

Region/Country:  
  • EU/EEA

Type of Actor:

  • Patient Organisations
  • European Patient Organisations

Development Stage:

  • Clinical Research
  • Translational Research
  • Commercialisation
  • Patient and Public Involvement

Additional information

EPF is an independent non-profit, non-governmental umbrella organisation of patient organisations across Europe and across disease-areas

European Society of Gene and Cell Therapy (ESGCT)

Region/Country:  
  • EU/EEA

Type of Actor:

  • Networks
  • National and International Societies

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Translational Research

Additional information

ESGCT promotes basic and clinical research in gene therapy, cell therapy and genetic vaccines by facilitating education, the exchange of information and technology and by serving as a professional adviser to stakeholder communities and regulatory bodies in Europe.

Federal Agency for Medicines
and Health Products
(FAMHP)

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

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
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The FAMHP is the Belgian competent authority in charge of ensuring the quality, safety and efficacy of medicines and health products (medical devices and accessories, raw materials, blood and blood components of human origin, human tissue material), for human and veterinary use, in clinical development and on the market.

Resources

FAMHP's information for the public: https://www.famhp.be/en/public_information
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