Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

Latest Glossary Definitions

Disease Risk-factor Reduction Claims (RDRC)

Possibly the highest level of medicine-like health claim that can be made on a non-drug product. It describes the propensity for the product or dietary ingredient to aid in the reduction of the risk factors associated with particular diseases.

European Network for Health Technology Assessment (EUnetHTA)

The European network for Health Technology Assessment is a network of government-appointed organizations from European Union Member States, the European Economic Area and accession countries as well as a large number of relevant regional agencies and non-for-profit organizations that produce or c

EudraCT Form

A harmonized application form is used for clinical trial applications across the European Union.

End of Trial (EoT) Declaration

Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.

Good Clinical Practice (GCP)

As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are accurate, and that the rights, integrity, and confidentiality of trial subjects ar

Health Economic Model

A logical mathematical framework demonstrating the quantitative relationship between a defined set of variables (e.g. cost, effectiveness, net benefit) based upon an explicit set of parameters and assumptions.

Integrated summary of Safety (ISS)

Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to fulfil FDA requirements for an NDA or BLA in the US.

Innovative Medicine

A medicine that contains an active substance or combination of active substances that has not been authorised before.

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