The Pharmacovigilance Risk Assessment Committee is the European Medicines Agency’s expert body for safety issues concerning medicinal products for human use. It assesses risks throughout the entire life cycle of an authorized medicinal product and formulates regulatory recommendations based on these assessments. Its English abbreviation, PRAC, is also utilized within German-language EU regulatory frameworks.<\/p>\n
The PRAC does not merely consider individual reported adverse reactions, but rather all aspects of risk management. This includes the identification, assessment, mitigation, and communication of risks associated with adverse drug reactions, while taking therapeutic benefits into account. Furthermore, the committee addresses the design and evaluation of post-authorisation safety studies as well as pharmacovigilance audits.<\/p>\n
This scope of responsibility explains why a safety issue does not require a confirmed cause to reach the PRAC. A signal from EudraVigilance, literature data, or a study can trigger a scientific review. Depending on the outcome, recommendations may involve adjustments to product information, additional risk minimisation measures, a Post-Authorisation Safety Study, or closer monitoring of an event.<\/p>\n
According to the EMA, the committee meets monthly. Its work is based on assessments, rapporteur submissions, and member discussions; it is thus distinct from the mere receipt of individual reports. While case processing provides the data, the PRAC determines its significance for a medicinal product’s risk profile.<\/p>\n
The PRAC issues recommendations on pharmacovigilance issues and risk management systems, including the monitoring of their effectiveness. For centrally authorised medicinal products and referral procedures, it directs these to the Committee for Medicinal Products for Human Use (CHMP). If the use of a medicinal product affects Member States, the Coordination Group for Mutual Recognition and Decentralised Procedures \u2013 Human (CMDh) is the primary recipient.<\/p>\n
In a PSUR single assessment, the PRAC rapporteur evaluates the safety data from the periodic report. If the committee concludes that regulatory action is indicated, the recommendation is forwarded to the CHMP or CMDh along with the assessment report. The downstream body and, where applicable, the European Commission proceed with the legal procedural steps; the PRAC does not replace these authorities.<\/p>\n
EU reference dates and submission frequencies for periodic safety update reports are also determined through the interaction of these bodies. GVP Module VII describes that the CHMP or CMDh, following consultation with the PRAC, may decide on data lock points and frequencies. Thus, the committee influences safety monitoring without being a marketing authorisation holder, national authority, or database operator itself.<\/p>\n
The PRAC is a committee of the EMA and is not a national medicines authority. National competent authorities continue to perform tasks within their Member States, reporting and evaluating information within the European network, and may be involved in procedures. A national authority does not become the PRAC simply by utilizing the same safety data.<\/p>\n
Similarly, the PRAC is not to be equated with the Food and Drug Administration. The latter is a US authority operating under a different legal framework. Furthermore, the ICH (International Council for Harmonisation) develops internationally harmonised guidelines but is not a European decision-making body for specific medicinal product risks.<\/p>\n
For practical classification, the direction of activity is decisive: the PRAC issues scientific-regulatory recommendations within the EU system. A national authority executes or assesses matters in its national role; the CHMP, CMDh, and the Commission subsequently perform their own respective procedural legal functions.<\/p>\n
For clinical trials, the PRAC is primarily relevant when findings from post-authorisation development impact further planning. New risks may necessitate an update to the Investigator’s Brochure, protocol, informed consent documents, or safety monitoring. For medicinal products with mandated additional measures, sponsors and trial sites must transparently implement which safety information applies to the ongoing study and when documents must be regulatorily adjusted.<\/p>\n
Full-service CROs like Mediconomics provide support in PRAC-related matters by evaluating affected safety data, coordinating between Pharmacovigilance, Regulatory Affairs, and Medical Writing, and preparing documentation for amendments to study protocols and Investigator’s Brochures. Project teams can also track the implementation of mandated risk minimisation measures at trial sites and integrate the required documentation into study workflows.<\/p>\n
Does the PRAC decide on the withdrawal of a marketing authorisation itself?<\/strong><\/p>\n The PRAC formulates recommendations based on safety assessments. If a recommendation leads to a variation, suspension, or withdrawal, the CHMP or CMDh and, if applicable, the European Commission carry out the further designated steps.<\/p>\n Why does the PRAC also review post-authorisation safety studies?<\/strong><\/p>\n Such studies may be mandated or agreed upon to clarify a specifically identified safety concern after authorisation. Their design and results are therefore part of risk management, which falls within the PRAC’s area of responsibility.<\/p>\n Is every report stored in EudraVigilance already a PRAC recommendation?<\/strong><\/p>\n No. EudraVigilance provides data to the PRAC for signal detection but is not the venue for committee decisions. Only the professional discussion of a signal or another safety issue can result in a recommendation by the committee.<\/p>\n The Pharmacovigilance Risk Assessment Committee is the European Medicines Agency’s expert body for safety issues concerning medicinal products for human use. It assesses risks throughout the entire life cycle of an authorized medicinal product and formulates regulatory recommendations based on these assessments. Its English abbreviation, PRAC, is also utilized within German-language EU regulatory frameworks. Mandate […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[23],"class_list":["post-8086","glossary","type-glossary","status-publish","hentry","glossary-cat-pharmakovigilanz"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/8086","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/8086\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=8086"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=8086"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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