A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness

The legal authority that is responsible for regulating all matters relating to drugs and medicinal products (e.g.: EMA, FDA, MHRA)

Product information Healthcare professional communications / educational materials Patient communications / educational materials

MAHs must prepare an RMP (Risk Management Plan) to implement the risk management system.

Activity that aims to ensure that the benefits of a medicinal product exceed the risks by the greatest achievable margin, by increasing the benefits or

The probability of developing an outcome (refers normally but not always to a negative outcome). Absolute risk or Incidence Rate: The observed or calculated probability of the

Risk in a population of unexposed persons. It can be measured over time (incidence) or at a given time (prevalence).

Therapeutic practice where drugs are prescribed and used appropriately for the indication and the patient’s specific characteristics.

Rechallenge means reintroducing the drug to the patient. A positive rechallenge (the AE reappears) strongly suggests a causal relationship.

Active efforts by investigators to identify subjects who may be suitable for enrollment into a clinical trial. Subjects are selected on the basis of the

Real-world studies seek to provide a line of complementary evidence to that provided by randomized controlled trials (RCTs). While RCTs provide evidence of efficacy, real-world

A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance. Source: Clinicaltrials.gov

The process of assigning trial subjects to investigational treatment or control groups (may use a comparator) using an element of chance to determine the assignments

A route of administration is a way of administering a drug to a site in a patient. A comprehensive list of specific routes of administration

[FDA] In a rolling submission (also known as rolling review), a drug company can submit completed sections of its Biologic License Application (BLA) or New

Sequences may be related to one another within one regulatory activity. The related sequence number should always be stated. In case of activities with only

Act of gathering and analyzing regulatory information and monitoring current regulatory climate and using this data to generate creative and innovative regulatory strategies designed to

Regulatory Information Management refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products across the life sciences value

The department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies. Each drug sponsor has a regulatory

A public authority or government agency responsible for exercising autonomous authority over some area of human activity in a regulatory or supervisory capacity. An independent

A Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. Now generally known as eCTD Version 4.

[EMA] The European Union Member State that leads the review of an application in a mutual recognition procedure or decentralised procedure. Source: EMA Glossary

[FDA] The listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application. Source: 21

[EMA] One of the two members of a committee or working party who leads the evaluation of an application. Source: EMA Glossary