Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a

pharmaceutical drug A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and re ...

medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...

after it has been released on the market and is an important part of the science of

pharmacovigilance Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharma ...

. Since drugs and medical devices are approved on the basis of

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

s, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing

surveillance Surveillance is the monitoring of behavior, many activities, or information for the purpose of information gathering, influencing, managing or directing. This can include observation from a distance by means of electronic equipment, such as c ...

can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions. Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring,

electronic health record An electronic health record (EHR) is the systematized collection of patient and population electronically stored health information in a digital format. These records can be shared across different health care settings. Records are shared throu ...

s, patient registries, and

record linkage Record linkage (also known as data matching, data linkage, entity resolution, and many other terms) is the task of finding records in a data set that refer to the same entity across different data sources (e.g., data files, books, websites, and da ...

between health databases. These data are reviewed to highlight potential safety concerns in a process known as data mining.

National implementation

Canada

Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...

is the regulatory body which approves drugs, and it has a division called "Marketed Health Products Directorate" (MHPD) which coordinates Canadian postmarketing surveillance.

European Union

The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for ''medical device post-market surveillance'' (materiovigilance). A manufacturer of medical devices is required to report incidents (serious adverse events) to the national competent authority of the member state the company resides in. The Medical Device

Regulation (EU) 2017/745 Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concer ...

(MDR) provides in §2 the following definition of post-market surveillance:

‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

Further requirements on PMS are given in §83 of the MDR; §84 details PMS Plan requirements and references Section 1.1 of Annex III of the MDR; §85 details the PMS report, while §86 describes the contents of the Periodic Safety Update Report (PSUR). Similar provisions on Post-Market Surveillance are found in the European regulation on in vitro diagnostic medical devices (

IVDR iVDR, or Information Versatile Disk for Removable usage, is a portable HDD cartridge standard. The standard is managed by the iVDR Hard Disk Drive Consortium, which consists largely of Japanese corporations. It provides the benefits of HDD tech ...

United Kingdom

The

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...

(MHRA) and the

Commission on Human Medicines The Commission on Human Medicines (CHM) is a committee of the UK's Medicines and Healthcare products Regulatory Agency. It was formed in October 2005, and assumed the responsibilities of the Medicines Commission and the Committee on Safety of Medi ...

(CHM) jointly operate the

Yellow Card Scheme The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored. History ...

, which was one of the first examples of a pharmacovigilance scheme, aimed at mitigating

adverse drug reaction An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term ...

s (ADRs).

United States

Postmarketing surveillance is overseen by the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA), which operates a system of passive surveillance called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. The FDA also conducts active surveillance of certain regulated products. For example, the FDA may monitor safety and effectiveness of medical devices through either a Post-Approval Study or through a 522 Postmarket Surveillance Study. With respect to regulation, two terms are defined: Postmarketing requirements are studies and clinical trials that sponsors are required to conduct and postmarketing commitments are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statue or regulation.{{cite web , last1=FDA , url=https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments , title=Postmarketing Requirements and Commitments: Introduction, website=

References