Clinical data available

 

Scope of the clinical data publication policy

This website contains clinical data published under the European Medicines Agency's (EMA) policy on the publication of clinical data.

Clinical data are defined as clinical reports and individual patient data (IPD).

EMA will implement the policy in two phases.

Phase 1 concerns the publication of clinical reports submitted to the Agency as shown in the table below, regardless of the outcome of the regulatory procedure. It entered into force on 1 January 2015.

 

Regulatory procedure Submitted to EMA from
As part of a marketing authorisation application (MAA) or submitted by a third party in the context of a MAA 1 January 2015
As part of a procedure under Article 58 of Regulation (EC) No 726/2004 (medicines for use outside the EU) 1 January 2015
As part of new indication or line extension applications relating to existing centrally authorised medicinal products 1 July 2015

 

 

 

 

 

 

 

 

 

Data requested by EMA and/or submitted by the applicant/marketing authorisation holder (MAH) as additional clinical data during the scientific assessment process for these regulatory procedures are also in scope of the policy. 

EMA will determine the effective date of the policy for all other post-authorisation procedures at a later date.

Phase 2 concerns the publication of IPD. EMA will implement this phase at a later stage.

For more information on the policy and its background, including the consultation exercise, see: 

 

Information published

The data that EMA publishes on this website have been submitted to EMA by pharmaceutical companies to support their request for marketing authorisation and have been assessed by Committee for Human Medicinal Products (CHMP).

For each regulatory procedure, EMA publishes a European public assessment report on its corporate website, which contains the CHMP's assessment of the data.

For more information on EMA's role in the authorisation of medicines in Europe, see the EMA corporate website.

Clinical reports normally include the following types of document:

  • clinical overview: provides a critical analysis of the clinical data submitted in the dossier. It should present the risks and limitations of the medicine development programme and the study results, analyse the benefits and risks of the medicinal product in its intended use and describe how the study results support critical parts of the prescribing information;

  • clinical summary: provides a detailed factual summary of the clinical information in the dossier. It includes information provided in clinical study reports from any meta-analyses or other cross study analyses for which full reports have been provided in the submission, as well as post-marketing data for products that have been marketed outside of the EU;

  • clinical study report: (CSR) is a detailed document about the methods and results of a clinical trial. It is a scientific document addressing safety and efficacy and its content is similar to an academic paper. It has several appendices and the following 3 are available:

  • protocol and protocol amendments: describe the objectives, design, methods, statistical considerations and organisation of a clinical trial, and include any protocol modifications;
  • sample case report form: is a questionnaire (in print or electronic format) used by the sponsor of the clinical trial to collect data from each participating site;
  • documentation of statistical methods: provides a description of the planned methods for collection, analysis, interpretation, presentation, and organisation of the data.

These documents correspond respectively to modules 2.5, 2.7 and 5.3 of the common technical document (CTD).

The quantity of data published varies considerably per product, ranging from fewer than ten to hundreds of documents. This is because the quantity and type of clinical data submitted to support a marketing authorisation application (MAA) for a given product depend on the legal basis for the regulatory submission, as specified in articles 8 and 10 of Directive 2001/83/EC.

For example, a MAA for an innovative medicinal product may contain several clinical trial reports, whereas a MAA for a generic or hybrid medicine may contain a single bioequivalence trial report.

Exclusions

The following document types are not published as the policy does not apply to them:

  • clinical data submitted to EMA as part of an initial marketing authorisation application before 1 January 2015 or as part of new indication or line extension applications submitted before 1 July 2015; 
  • clinical data on centrally authorised products that are not held by EMA (e.g. clinical trials on an authorised product conducted by independent investigators and not submitted to the Agency);
  • clinical data submitted to the Agency for non-centrally authorised products (e.g. in the context of a referral procedure);
  • pharmacovigilance data based on individual case safety reports (ICSRs). Access by third parties to ICSR data is addressed in EMA’s EudraVigilance access policy;
  • components of an application that do not fall under the definition of “clinical data”, with the exception of the anonymisation report.

For more information, see the EMA corporate website.

 

Redaction of information

In order to comply with European legislation on protection of personal data (PPD), clinical reports must be anonymised to prevent patients and professionals who participated in clinical trials from being identified. This usually involves redacting personal data.

The redaction of personal data displays in the documents as a light blue box with a black 'PPD' label.

EMA publishes the applicant's anonymisation report, which describes the applicant's PPD anonymisation methods and their impact on data utility. The information in the anonymisation report should not in itself lead to an increased risk of patient re-identification.

EMA considers that, in general, clinical data cannot be considered commercially confidential information (CCI). Companies must justify the redaction of any CCI which, in limited circumstances, may be contained in study reports.

The redaction of CCI displays in the documents as a black box with a red 'CCI' label.

Please note that CCI in the published documents has been redacted at the time of the European Commission Decision on the regulatory procedure, and subsequent developments that might impact on CCI redaction are not taken into account.

The amount of redaction can vary for different types of medicinal product. For example, clinical data supporting the authorisation of an innovative medicinal product is likely to contain more CCI than that supporting a generic or biosimilar medicine. Similarly, data for orphan and paediatric medicines require greater anonymisation of personal data. 

EMA has published guidance for industry on the anonymisation of personal data and the redaction of commercially confidential information.

For more information, see the EMA corporate website.

 

Timelines for publication

EMA aims to publish the clinical reports as per the following timelines:

Procedure type Publication timelines

Marketing authorisation, line extension and extension of indication applications

60 days after the European Commission decision and following publication of the EPAR.

Article 58 applications

within 150 days after the CHMP opinion.
Withdrawn applications within 150 days after the receipt of the withdrawal letter.

 

Please note that there will be some delay in publishing clinical data submitted in 2015 and 2016. EMA expects to implement the above timelines by the end of 2017.