Medical terms simplifier
EMA’s medical terms simplifier gives plain-language descriptions of medical terms commonly used in information about medicines:
The resource focuses on side effects and other terms used in medicines information and assessments of medicines.
The medical terms simplifier does not cover rarely used terms, most disease states, very specialised areas or the broader field of medical science. EMA will issue updates of the document.
Glossary of regulatory terms
EMA's glossary of regulatory terms gives definitions for the main regulatory terms used on this website and in EMA documents.
Click on a letter below to see terms beginning with that letter.
Disclaimer: EMA has developed the definitions in this glossary to help this website's users understand regulatory terminology. Definitions may differ from those given in European Union legislation.
The leaflet in every pack of medicine that contains information on the medicine for end-users, such as patients and animal owners.
The committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals. Abbreviated as PDCO.
More information can be found under 'Paediatric Committee (PDCO)'.
A development plan aimed at ensuring that the necessary data are obtained to support the authorisation of a medicine for children, through studies in children. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed paediatric investigation plan, unless the medicine is exempt because of a deferral or waiver
More information can be found under 'Paediatric investigation plans'.
A type of marketing authorisation covering the indication(s) and appropriate formulation(s) for the paediatric population, which was introduced by the Paediatric Regulation. Applicants can request paediatric-use marketing authorisations for medicines that are already authorised, are no longer covered by a supplementary protection certificate or a patent that qualifies as such and are developed exclusively for use in children.
Abbreviated as PUMA.
More information can be found under 'Paediatric-use marketing authorisations'.
The distribution of a medicine from one Member State to another by a pharmaceutical company independently of the marketing authorisation holder.
More information can be found under 'Parallel distribution'.
An official document securing the exclusive right to make, use, or sell an invention to its inventor for a defined period.
Paediatric Committee: the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.
More information can be found under 'Paediatric Committee (PDCO)'.
A report prepared by the marketing-authorisation holder describing the worldwide safety experience with a medicine at a defined time after its authorisation. Abbreviated as PSUR.
More information can be found under 'Periodic safety update reports: questions and answers'.
A medicine that is targeted to individual patients, based on their genetic characteristics.
The way a medicine is presented, e.g. tablet, capsule, solution for injection, cream, etc.
The study of how the variability of the expression of genes between people leads to differences in susceptibility to disease and responses to medicines.
Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
More information can be found under 'Pharmacovigilance: Overview'.
The committee that is responsible for assessing all aspects of the risk management of medicines for human use. Abbreviated as PRAC.
More information can be found under 'Pharmacovigilance Risk Assessment Committee (PRAC)'.
A type of clinical study where a new medicine is given to humans for the first time, usually in healthy volunteers. It looks at the way the medicine is dealt with by the body, its main effects and main side effects.
A type of clinical study conducted after phase I studies to evaluate a medicine’s effects in a particular condition and to determine its common short-term side effects.
A type of clinical study usually conducted in a large group of patients to gather information about a medicine's efficacy and safety, to allow its benefits and risks to be evaluated.
A type of clinical study that takes place after the authorisation of a medicine.
Documentation providing detailed information on the characteristics of the human plasma used in a medicine or a medical device.
More information can be found under 'Plasma master file (PMF) certification'.
Pharmacovigilance Risk Assessment Committee: the committee that is responsible for assessing all aspects of the risk management of medicines for human use.
More information can be found under 'Pharmacovigilance Risk Assessment Committee (PRAC)'.
Documents providing officially approved information for healthcare professionals and patients on a medicine. The product information includes the summary of product characteristics, package leaflet and labelling.
More information can be found under 'Product-information requirements'.
An exemption from the obligation to acquire data, through a paediatric investigation plan, in some or all subsets of the paediatric population for a given condition, route of administration and pharmaceutical form of a specified medicine. Product-specific waivers are adopted by the Paediatric Committee (PDCO).
More information can be found under 'Class waivers'.
A type of scientific advice for developers of orphan medicines.
More information can be found under 'Scientific advice and protocol assistance'.