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.
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
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
A harmonized application form is used for clinical trial applications across the European Union.
The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal requirement from the 2010 pharmacovigilance legislation.
Electronic or paper filing system which must contains all study documents and at least essential documents as described in ICH E6.
Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.
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
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.
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.
A medicine that contains an active substance or combination of active substances that has not been authorised before.