Publication of clinical data under EMA Policy 0070 refers to the public disclosure of certain documents from centralized marketing authorisation procedures by the European Medicines Agency. The policy applies to clinical data submitted as part of a Marketing Authorisation Application and assessed by the CHMP. Before publication, the marketing authorisation holder reviews the protection of personal data in particular and may request the redaction of narrowly defined confidential commercial information.<\/p>\n
The EMA developed Policy\/0070 pursuant to Article 80 of Regulation (EC) No 726\/2004. It applies to clinical data submitted in the centralized marketing authorisation procedure as part of a Marketing Authorisation Application, in certain post-authorisation procedures, or in the context of an application. Publication takes place regardless of the outcome of the regulatory procedure, provided the policy applies to the data in question.<\/p>\n
The EMA describes its objectives as enabling public scrutiny, supporting the use of new knowledge in research, promoting better-informed use of medicines, and allowing the review of scientific conclusions. Clinical Study Reports are particularly important for this transparency, as they can contain extensive information on study design, results, and safety. The policy is therefore not a general freedom-of-information procedure for any document, but a specific publication framework for clinical data in the context of marketing authorisation.<\/p>\n
Before publication, the marketing authorisation holder submits an anonymization report. It describes the method applied and its impact on data quality. The purpose is to reduce the risk of re-identification of study participants without unnecessarily compromising the informational value of the published clinical data.<\/p>\n
In the published documents, personal data are displayed as light blue fields labeled PPD. Confidential commercial information, where a justified redaction is accepted, appears as black fields labeled CCI. This visible distinction not only indicates the type of information removed but also makes the extent of each redaction clear to users of the document.<\/p>\n
The EMA states that clinical data are, in principle, not to be regarded as confidential commercial information. This does not mean that every detail is published without restriction: personal data must still be protected, and in exceptional cases, specific confidential commercial information may be justified. The policy thus separates data protection and CCI review from a blanket claim of confidentiality over the entire study report.<\/p>\n
The Clinical Study Report is the document that provides a comprehensive account of the course and results of a study. Publication under EMA Policy 0070, by contrast, describes what happens to certain clinical documents after their submission in the centralized procedure. It should also be distinguished from Policy 0043, which concerns access to EMA documents, whereas Policy 0070 establishes a proactive publication procedure.<\/p>\n
The publication of clinical data must be distinguished from the publication of the marketing authorisation decision and its product information. Assessment reports, the summary of product characteristics, and the Clinical Study Report serve different informational purposes and do not contain the same level of detail. For document preparation, this means that a report must not be shortened according to the standards of promotional material. Its scientific readability remains a separate review point alongside the redaction of information requiring protection.<\/p>\n
The documents are made accessible in the EMA’s clinical data publication portal. For companies, this means that not only the quality of the submitted Clinical Study Report is relevant, but also the consistency between the submitted version and the version prepared for publication. Any redaction must be justified and traceable. Not all information that may appear commercially sensitive meets the strict threshold for confidential commercial information.<\/p>\n
The possibility of future disclosure already affects the preparation of study reports during development. Personal data may appear in free text, appendices, data listings, or site information; at the same time, the core scientific conclusions must not become unclear due to uncontrolled redaction practices. For submission, the CSR, the anonymization strategy, and the justification for any CCI requests must therefore be coordinated in terms of timing.<\/p>\n
Full-service CROs such as Mediconomics support compliance with Policy 0070 through the structured preparation of Clinical Study Reports, the identification of potential personal data, and the coordination of anonymization documentation. Medical writing and pharmacovigilance can review narratives for consistent safety information, while data protection and regulatory affairs functions support the justified redaction proposals. Quality management documents which version was reviewed and approved for submission.<\/p>\n
Who publishes the clinical data under Policy 0070?<\/strong><\/p>\n The European Medicines Agency publishes the documents as part of its clinical data publication activities. The marketing authorisation holder provides the data and the necessary documentation for anonymization.<\/p>\n What does the PPD label mean?<\/strong><\/p>\n PPD stands for personal data (protected personal data). In the EMA’s published documents, such protected information is marked as light blue redaction fields.<\/p>\n Does Policy 0070 apply to every clinical trial in the EU?<\/strong><\/p>\n No. The policy applies only to clinical data from the centralized marketing authorisation procedures specified within its scope. The transparency of EU clinical trials is additionally governed by the framework of Regulation (EU) No 536\/2014.<\/p>\n Publication of clinical data under EMA Policy 0070 refers to the public disclosure of certain documents from centralized marketing authorisation procedures by the European Medicines Agency. The policy applies to clinical data submitted as part of a Marketing Authorisation Application and assessed by the CHMP. Before publication, the marketing authorisation holder reviews the protection of […]<\/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":[29],"class_list":["post-8193","glossary","type-glossary","status-publish","hentry","glossary-cat-medical-writing-transparenz"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/8193","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\/8193\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=8193"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=8193"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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