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 Testa may refer to:
* Testa (botany), a term to describe the seed coat
* Testa (surname)
* Testa, Hurwitz & Thibeault, a former Boston law firm
* 11667 Testa, a main-belt asteroid discovered in 1997
* Testa (ceramics), fired clay material, espe ...
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 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
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eHealth
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EudraCT
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EudraGMP
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EudraPharm
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EudraVigilance
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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
Under European Union (EU) law, the qualified person (QP) is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU, or imported into the EU. Such ...
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 ...
)
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 ...
)
European clinical research
Pharmaceuticals policy