Additional monitoring designates medicinal products for which authorities collect information particularly closely following authorisation. A black inverted triangle appears in the summary of product characteristics and package leaflet with a statement that the medicinal product is subject to additional monitoring. The symbol does not mean that the medicinal product is unsafe.<\/p>\n
All authorised medicinal products are subject to pharmacovigilance. Additional monitoring, however, intensifies attention for medicinal products where the clinical evidence base is typically less well developed or for which a particular need for further data exists. It is intended in particular to promote the reporting of suspected adverse reactions and to help authorities incorporate new information early into the ongoing benefit\u2013risk assessment.<\/p>\n
The black triangle appears in the product information, not on the outer packaging or labelling. The combination of symbol and explanation is intended to encourage healthcare professionals as well as patients to report suspected adverse reactions. This does not imply that a known risk is greater than for other medicinal products; it is a transparency and observation instrument.<\/p>\n
The EMA maintains, together with the Member States, the public list of medicinal products under additional monitoring. Under Article 23 of Regulation (EC) No 726\/2004, this includes in particular medicinal products containing a new active substance authorised after the legally defined reference date, biological medicinal products, and medicinal products authorised under conditional approval or under exceptional circumstances. The list may also include medicinal products for which a post-authorisation safety study or specific conditions for safe use have been imposed.<\/p>\n
For the automatically included categories, a medicinal product remains on the list for five years as a rule; the EMA may extend the duration on the recommendation of the PRAC. For medicinal products included because of a specific obligation, removal depends on fulfilment of the relevant condition and regulatory decision. The product information must reflect the status in each case.<\/p>\n
Inclusion does not occur on the basis of a single reported case. It is based on the categories laid down in Article 23 or on a targeted decision in connection with a post-authorisation study or condition imposed. The EMA publishes and updates the list so that status and active substances can be transparently tracked. Marketing authorisation holders must verify that the prescribed statement and triangle appear correctly in the current product information texts.<\/p>\n
The labelling is directed at reporting suspected adverse reactions. It does not alter the indication or the authorised dose, nor does it replace individual medical benefit\u2013risk assessment. When new data emerge, they are evaluated through the regular pharmacovigilance processes. The black triangle is therefore a visible indication of the need for information, not itself the measure for assessing or minimising a specific risk.<\/p>\n
Additional monitoring is also dynamic. The list contains medicinal product names and active substances and is updated with the participation of the Member States. It is therefore not sufficient to regard an earlier product information version as permanently authoritative. Marketing authorisation holders, healthcare professionals, and those involved in development must work with the current approved product information and take account of changes in their safety and communication processes.<\/p>\n
Additional monitoring is not a separate pharmacovigilance system and does not replace regular obligations. For every medicinal product, suspected cases must be captured, assessed, and reported where necessary; in addition, signal management, risk management, and regular benefit\u2013risk assessment exist. The black triangle supplements these ongoing obligations through visible labelling and a legally defined list.<\/p>\n
Additional monitoring is therefore not to be equated with the existing concept of pharmacovigilance. Pharmacovigilance encompasses the entire system for detecting, assessing, understanding, and preventing adverse reactions and other medicine-related problems. Additional monitoring is a limited instrument within this system and not a quality judgement on a product.<\/p>\n
For clinical development, the status is relevant because further safety information from studies, registries, and routine use accumulates after authorisation. Development programmes should therefore provide traceable safety documentation, clear reporting pathways, and ongoing planning of follow-up. Particular attention is given to consistent reference safety information and the transfer of study data into pharmacovigilance.<\/p>\n
Full-service CROs such as Mediconomics support safety management plans, safety reports, case processing, medical writing, and the alignment of clinical data with pharmacovigilance processes. They can also organisationally accompany the tracking of additional obligations and the consistency of product information drafts.<\/p>\n
Does the black triangle mean that a medicinal product is dangerous?<\/strong><\/p>\n No. It indicates that the medicinal product is being monitored particularly closely and that the reporting of suspected adverse reactions is to be promoted.<\/p>\n Does every biological medicinal product carry a black triangle?<\/strong><\/p>\n Biological medicinal products belong to the legally provided categories of additional monitoring. The current status is to be verified in the product information and on the EMA list.<\/p>\n Does additional monitoring end automatically?<\/strong><\/p>\n For the automatically included categories, a five-year period applies as a rule; for specific obligations, the duration depends on their fulfilment and regulatory decision.<\/p>\n Additional monitoring designates medicinal products for which authorities collect information particularly closely following authorisation. A black inverted triangle appears in the summary of product characteristics and package leaflet with a statement that the medicinal product is subject to additional monitoring. The symbol does not mean that the medicinal product is unsafe. Purpose of Additional Monitoring […]<\/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":[20],"class_list":["post-8037","glossary","type-glossary","status-publish","hentry","glossary-cat-regulatory-affairs-zulassung"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/8037","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\/8037\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=8037"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=8037"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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