Glossaries

A formal agreement between the Food and Drug administration (FDA) and federal, state, or local government agencies; academic institutions; and other entities. NOTE: The MOU constitutes an understanding between the parties but is a non-binding agreement. it is FDA's policy to enter into MOUs with other entities whenever there is a need to define lines of authority or responsibility, or to clarify cooperative procedures.

Massive trials that test the advantages of therapeutic interventions by enrolling 10,000 or more subjects.

The UK government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. [MHRA]

Name as authorized by a Medicines Regulatory Agency. NOTE: As a general principle, a marketing authorization is granted to a single Marketing Authorization Holder or sponsor who is responsible for placing a single Medicinal Product on the market. The marketing authorization contains the name of the Medicinal Product, which can refer to, for example, a single invented name or a scientific name [when available, the INN of the active substance(s)] accompanied by a trademark or other characteristics. Other characteristics of the name can refer to strength, pharmaceutical form, intended usage or an administration device, etc. [After ISO 11615:2017, 3.1.54] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name.

Unique identifier allocated to a medicinal product supplementary to any existing authorization number as ascribed by a medicines regulatory agency in a jurisdiction. NOTE: proposed by IDMP as a new universal identifier. [After ISO 11615:2017, 3.1.53]

Categorisation or grouping of Medicinal Products based on specific properties and according to various classification systems (e.g., UNII-SRS), which may be regional or international. NOTE: The classification system is specified using an appropriate identification system; the applicable controlled term and the controlled term identifier is specified. [after ISO 11615 2017-10 on Regulated Medicinal Product information]

Any substance or combination of substances that may be administered to human beings (or animals) for treating or preventing disease, or with the intent to make a medical diagnosis or to restore, correct or modify physiological functions. NOTE: 1. A Medicinal Product may contain one or more manufactured items and one or more pharmaceutical products. 2. In certain jurisdictions a Medicinal Product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis. [After IDMP]

Any unintentional error in the prescribing, dispensing or administration of a medicinal product while in the control of the healthcare professional, patient or consumer. [HMA, Guideline on good pharmacovigilance practices (GVP)]

Act of tracking the progress or severity of a disease, injury or handicap in patients in order to support a medical purpose. See also monitoring.

A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial.

Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more specific medical purpose(s). NOTE: Specific medical purposes include diagnosis; prevention; monitoring; treatment or alleviation of disease; diagnosis; monitoring; treatment; alleviation of or compensation for an injury; investigation; replacement; modification; or support of the anatomy or of a physiological process; supporting or sustaining life, control of conception; disinfection of medical devices providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices; After MHRA Guidance: Medical device stand-alone software including apps]

Pharmaceutical products, such as vaccines, antimicrobials, and antitoxins, and nonpharmaceutical products, such as ventilators, diagnostic tests, personal protective equipment (PPE), and patient (also general) decontamination materials, that may be used to prevent, mitigate, or treat the adverse health effects from a public health emergency. [After National Health Security Strategy 2019-2022]

The middle value in a data set; that is, just as many values are greater than the median and lower than the median value. (With an even number of values, the conventional median is halfway between the two middle values.)

A global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others.

The sum of the values of all observations or data points divided by the number of observations; an arithmetical average.