Help - Clinical Data Publication
Table of contents
You need to have an EMA account to log into this website.
If you have access to any of the following EMA-hosted websites or online applications, you already have an EMA account and you should use the same credentials:
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If you do not already have an EMA account, you need to create an EMA account .
Once you have an EMA account, you need to log into this website to access the published clinical data.
- General information purposes: the intended use of the clinical data is for general and non-commercial purposes. You can view on screen any report.
- Academic and other non-commercial research purposes: the intended use of the clinical data is for academic and other non-commercial research purposes. You can view on screen and download any report.
For details of how personal data are processed and retained by EMA, see the data protection notice .
This website has been tested on Windows 7 to be compatible with the latest versions of the most commonly used web browsers, including Internet Explorer 11 and Google Chrome 52.
You must be logged in to access the clinical data. You should then use the search or the browse by category page under Find clinical data
You can enter any search term in the main search bar, such as the name of a medicinal product, an adverse drug reaction or a medical condition.
You also have the option of using the advanced search. You can search by:
- product name;
- active substance name/international non-proprietary name ( INN);
- anatomical therapeutic chemical ( ATC) code: this is a unique code assigned to a medicine according to the organ or system it works on and how it works. [Of note, the ATC code of a medicine can change and a single medicine can have several ATC codes];
- marketing authorisation holder (MAH)/Applicant: this is the natural or legal person(s) or organisation(s) that submitted the clinical reports to EMA, as well as any person(s) or organisation(s) who own(s) copyright or other intellectual property rights in the clinical reports;
- date of publication of the data: from October 2016.
You must enter at least 3 characters to return results.
You can choose to filter the search in the following ways:
- 'Include': this category includes authorised medicines, medicines that have been refused a marketing authorisation or whose marketing authorisation application has been withdrawn, and medicines intended exclusively for markets outside of the EU approved in cooperation with the World Health Organisation under article 58 of Regulation (EC) 726/2004;
- 'type of procedure': you can filter the regulatory procedure for which the clinical data were submitted. Procedure types include marketing authorisation applications, line extensions and extensions of indication. For details on procedure types, please see the glossary of the EMA website;
- 'type': you can filter the type of product (generic, biosimilar or orphan) or type of marketing authorisation (conditional approval or exceptional circumstances). These types are not mutually exclusive e.g. an orphan medicine can have a marketing authorisation under exceptional circumstances.
'Help' boxes on the left-hand side of the web page provide useful tips on using the search function.
This option allows you to browse alphabetically by product or by MAH/applicant. You can also browse based on 'Type' by selecting a category of product (generic, biosimilar or orphan) or of marketing authorisation (conditional approval or exceptional circumstances). You can also filter the results by product status - see 'Include' category under 2.1.1. Advanced search.
This page allows you to search for the 15 most viewed clinical dossiers by general or academic users.
The results are displayed in the search results table. You can use the six categories in the table header to sort your results. Each row of results has up/down arrow icons. Click on the down arrow icon to view more information, such as the ATC code, category of product (generic, biosimilar or orphan) or of marketing authorisation (conditional approval or exceptional circumstances), article 58 status and whether the marketing authorisation application was withdrawn.
Click on a medicinal product name to view its clinical data dossier page, including the procedure type and number. Clicking on the different sections of the dossier will reveal the individual documents, which you can view by clicking on the title. The documents are in PDF format and are text searchable.
You can download the search results table as a CSV-file and open it in MS Excel.
You can select the documents you wish to download by clicking the relevant box(es) on the left of the list of documents on the dossier page.
Only users registered to use the site for academic and other non-commercial research purposes can download clinical reports. You can upgrade your account to academic and other non-commercial research purposes by logging into your account and selecting 'Upgrade your access'.
The following types of clinical documents are available in the data dossier:
- clinical overview;
- clinical summary;
- clinical study report (CSR);
- protocol and protocol amendments;
- sample case report form;
- documentation of statistical methods;
- anonymisation report.
For more information see Clinical data available.
Please note that the applicant/MAH can choose to submit a clinical study report and its three appendices as a single document, or as four separate documents.
The Agency has taken steps to ensure that the risk of identification of patients involved in clinical trials is as low as possible.
Re-identification alert mechanism
If you are aware of any instance of possible re-identification of a patient, please report it using the online form on the EMA website and provide all the information available to you, including:
- product name;
- EMA procedure number (visible on the clinical data dossier page - see section 2.4);
- title of the relevant document(s);
- page number(s);
- URL of the page(s).
The Agency will promptly examine your complaint, review the corresponding published data and take appropriate action. The Agency will also notify the MAH.