The PSUR single assessment, also known as PSUSA, is the Union-wide assessment procedure for periodic safety update reports on an active substance or combination of active substances. It consolidates reports on medicinal products with different marketing authorisations and from different Member States so that the benefits and risks are assessed on a common data basis rather than separately.<\/p>\n
A PSUR single assessment is triggered by the inclusion of an active substance or combination of active substances in the EURD list. This list establishes Union reference dates and the frequency of report submission. The marketing authorisation holder therefore aligns submission not solely with its individual product but with the European schedule defined for the active substance.<\/p>\n
In the PSUSA procedure, the EMA assesses PSURs for medicinal products containing the same active substance, even if they do not share the same marketing authorisation or were authorised in different EU Member States. The reference unit is the active substance, not the individual authorisation: pursuant to Article 107e(1) of Directive 2001\/83\/EC, a single assessment is conducted for medicinal products authorised in more than one Member State, and in the cases referred to in Article 107c(4) to (6), for all medicinal products containing the same active substance or combination of active substances for which a Union reference date and reporting frequency have been established. Purely nationally authorised products therefore also fall within the Union-wide single assessment once the active substance is included in the EURD list with harmonised frequency. Only when an active substance is authorised Union-wide exclusively in a single Member State and no such harmonisation exists does the assessment under Article 107d remain with the competent national authority. The procedural logic prevents the same safety question from being answered in isolation for parallel authorisations.<\/p>\n
In the single assessment, the PRAC reviews the submitted cumulative benefit\u2013risk analysis and issues a recommendation. Depending on the type of authorisation, the outcome leads to a legally binding decision or to a CMDh position. Substantive consequences may include changes to the product information, suspension, or revocation of marketing authorisations; implementation is intended to be harmonised for the medicinal products covered by the EURD entry.<\/p>\n
The central technical question is not whether an individual PSUR is formally complete. What matters is whether the pooled data reveal a need for adjustment to the authorised medicinal products. This translates cross-product differences in case numbers, exposure, and risk description into a uniform regulatory conclusion.<\/p>\n
Following technical validation, the scientific assessment proceeds according to the timeline published by the EMA. The preliminary report by the PRAC Rapporteur or the Lead Member State forms the basis for questions to the marketing authorisation holders. They must respond to supplementary requests and, where applicable, proposals for product information wording in such a way that the joint conclusion can be implemented for all affected authorisations.<\/p>\n
The PSUSA is thus also a coordination instrument for product information. For centrally authorised medicinal products, a decision is published for each product. For nationally authorised products, the publication routes and CMDh involvement may be structured differently. For operational planning, the assignment of the respective product, procedural route, and expected implementation steps is therefore more important than the assumption that there is a single downstream decision for all authorisations.<\/p>\n
The PSUR single assessment is the procedure surrounding the report, not the report itself. The existing neighbouring entry periodic-safety-update-report designates the periodic safety update report prepared by the marketing authorisation holder with its benefit\u2013risk assessment. PSUSA, by contrast, describes the regulatory joint review of multiple such reports on the same substance or combination.<\/p>\n
Even a unified active-substance assessment does not replace the obligation to prepare product-specific information precisely. In the single assessment, the EMA requires information on all authorised medicinal products within the scope. Differences between pharmaceutical forms, indications, or exposure groups may remain relevant to the regulatory conclusion, even though the assessment is coordinated at the active-substance level.<\/p>\n
The joint assessment therefore enables a substance-based safety decision without making the administrative origin of individual authorisations the decisive criterion.<\/p>\n
Ongoing clinical trials may be affected by a PSUSA if their investigational medicinal product is already authorised or if product information is amended as a result of the procedure. The study team must then determine whether new warnings, contraindications, or risk-minimisation measures affect the investigator’s brochure, risk disclosure, safety assessment, or operational instructions at the trial site. Particularly important is the controlled assignment of the regulatory conclusion to each affected trial and product version.<\/p>\n
Full-service CROs such as Mediconomics support PSUR single assessments by evaluating published outcomes, coordinating pharmacovigilance and regulatory affairs, and providing documented assessment of the impact on the investigator’s brochure, safety communication, and trial documentation. Where amendments are necessary, they coordinate medical writing, quality management, and communication to trial sites according to the investigational medicinal products concerned.<\/p>\n
Is each medicinal product assessed individually in a PSUSA?<\/strong><\/p>\n The EMA conducts the assessment for the common active substance or combination of active substances. Product- and authorisation-specific differences remain part of the documentation and may influence implementation of the outcome.<\/p>\n Are only centrally authorised medicinal products covered by PSUSA procedures?<\/strong><\/p>\n No. The procedure may also include nationally authorised medicinal products as well as mixed configurations with central and national authorisations. The publication and decision routes depend on the respective type of authorisation.<\/p>\n Does the EURD list determine the content of the PSUR?<\/strong><\/p>\n The EURD list establishes reference dates and submission frequency. It does not turn the PSUR into a standard text; the submitted benefit\u2013risk analysis must still contain the safety data relevant to the medicinal product.<\/p>\n The PSUR single assessment, also known as PSUSA, is the Union-wide assessment procedure for periodic safety update reports on an active substance or combination of active substances. It consolidates reports on medicinal products with different marketing authorisations and from different Member States so that the benefits and risks are assessed on a common data basis […]<\/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-8035","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\/8035","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\/8035\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=8035"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=8035"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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