Implementing ActsFrom the European Commission: An implementing act is a non-legislative act laying down detailed rules allowing the uniform implementation of legally binding Union acts. Implementing powers are conferred in many cases on the European Commission, while in duly justified specific cases and in the(...)
Inactivated vaccineInactivated vaccines use the killed version of the pathogen that causes a disease.
IncidenceThe number of new cases of a health event (such as development of a disease, or reaction to a medicine) that occur during a specific time period, usually a year, in a specified population. Incidence is therefore also a measure of the risk of experiencing the health event during a certain(...)
Inclusion CriteriaInclusion criteria are the characteristics that potential participants must have in order to be considered for participation in a trial. They describe the patient population and patient selection criteria.Inclusion criteria should specify the type of testing used to make the patients'(...)
IndicationIn medicine, indication refers to a health condition (therapeutic area) for which a specific intervention (medicinal product, medical device, treatment, procedure) is developed to cure, relieve symptoms, prevent or diagnose. The indication, as specified in the Summary of Product(...)
Information Technology (IT) PlatformThe IT platform is the digital infrastructure that supports the exchange of information and data related to the EU HTA process. It facilitates the sharing of information among Member States, HTA bodies, and other stakeholders. For members of the public, the most relevant feature will be a(...)
Informed ConsentInformed consent is a person's voluntary agreement, based on an understanding of the relevant information, to participate in research or a clinical trial, or to undergo a particular medical intervention.Before any research may be carried out, participants must be informed about all aspects of(...)
Innovative characteristicsIn medicinal products, this may be defined as offering additional clinical efficacy or effectiveness as compared to the current best standard of care. Improvement to the use of a medicine in addition to an added clinical benefit (such as convenience to patients of, for example, a different(...)
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