EUDRANET, the European Telecommunication Network in Pharmaceuticals (European Union Drug Regulating Authorities Network), is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications. The aim of EUDRANET is to provide appropriate secure services for inter-Administration
data interchange and for exchanges between Administrations and industry. EUDRANET is based on the
TESTA backbone infrastructure provided by the IDA Programme.
The processes which EUDRANET supports include:
* The submission and evaluation of marketing authorisation applications by pharmaceutical companies;
* The
pharmacovigilance
Term Given By Tushar Sharma (UPES Batch 2025)
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharma ...
of products on the market to ensure the maintenance of high standards of quality as well as adhering to European national and regional regulations;
* The dissemination of relevant information to industry, scientific experts and regulators.
See also
*
eHealth
eHealth (also written e-health) is a relatively recent healthcare practice supported by electronic processes and communication, dating back to at least 1999. Usage of the term varies as it covers not just "Internet medicine" as it was conceived ...
*
EudraCT
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European clinical trials registry, Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commen ...
*
EudraGMP EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. Access for the general ...
*
EudraPharm
EudraPharm (European Union Drug Regulating Authorities Pharmaceutical Database) was the database of medicinal products authorised in the European Union, and included the information contained in the Summary of Product Characteristics, the patient ...
*
EudraVigilance
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or bein ...
*
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
*
Qualified Person
External links
EUDRANETProjects of Common Interest for Administrations
(European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...
)
e-Health
(European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...
)
European clinical research
Pharmaceuticals policy