The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than normally required.
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 use of an unauthorised medicine outside a clinical study in individual patients under strictly controlled conditions. This helps to make medicines that are still under development available to patients.
An accredited body that conducts conformity assessments for medical devices.
Affordability is the capability to allocate financial funds to an individual or societal need.
Real World Evidence (RWE) is the evidence derived from the analysis and/or synthesis of real-world data (RWD).
An umbrella term for data regarding the effects of health interventions (e.g. safety, effectiveness, resource use, etc) that are not collected in the context of highly-controlled RCT's.
A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else.
An official document securing the exclusive right to make, use, or sell an invention to its inventor for a defined period.
A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.
HTA is a multidisciplinary process that summarises information about the medical, social, economic, and ethical issues related to the use of health technology in a systematic, transparent, unbiased, robust manner.