By proactively publishing clinical data, EMA intends to help:
EMA has developed extensive guidance for industry to facilitate compliance with this policy.
EMA has resumed clinical data publication for medicines with new active substances that received a CHMP opinion from September 2023 onwards, or were withdrawn before the opinion stage.
EMA had temporarily suspended these activities for all except COVID-19 medicines in line with EMA's Final programming document 2023-2025 and its Management Board meeting of 14-15 December 2022.
The clinical data packages for non-COVID-19 medicines published following the resumption are available in January 2024 via EMA's clinical data website.
EMA now plans to expand activities (Step 2) related to Policy 0070 from April 2025.
More information on the next steps in the resumption of these activities:
Users need to visit EMA's clinical data website and log in with an EMA account. They can choose between an on-screen view only or a full download-and-print access. Terms of use apply - please see the clinical data website for details.
The Agency publishes the clinical data submitted by pharmaceutical companies to support their request for marketing authorisation, and which are assessed by the Committee for Human Medicinal Products (CHMP). Clinical data normally include:
These documents correspond respectively to modules 2.5, 2.7 and 5.3 of the ICH guideline M4 (R4) on common technical document (CTD) for the registration of pharmaceuticals for human use - organisation of CTD - Step 5 (CTD).
EMA revised its policy on publication of clinical data in March 2019, to take account of EMA's relocation to Amsterdam. In the revised policy, the governing law has changed from ‘England and Wales’ to ‘the Netherlands’, and the Amsterdam District Court replaces London as a (non-exclusive) judicial venue:
The policy applies to clinical data submitted to the Agency as shown in the table below, regardless of the outcome of the regulatory procedure.
| 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 |
For COVID-19 treatments and vaccines, EMA is publishing clinical data submitted to the Agency as part of any regulatory procedure.
This is because these products follow rapid review procedures and can be subject to early access mechanisms. As a result, companies submit clinical data on a regular basis and within different types of regulatory procedures.
For more information on the policy and its background, including the consultation exercise, see:
The policy does not apply to:
Clinical reports must be anonymised to prevent patients and professionals who participated in clinical trials from being identified, in order to comply with European legislation on personal data protection. This usually involves redacting personal data; the redaction appears as a light blue box with a black 'PPD' label. EMA publishes the applicant's anonymisation report, which describes the anonymisation methods they used and their impact on data utility.
Companies must also justify the redaction of any commercially confidential information (CCI).
The Agency considers that, in general, clinical data cannot be considered CCI but in limited circumstances study reports may contain CCI, which can be redacted. The redaction appears as a black box with a red 'CCI' label.
EMA reviews the company's redaction proposal and provides recommendations. The company then submits revised documents in line with EMA's recommendations and the Agency publishes the final version. The flowchart below summarises the process.
The technical anonymisation group (TAG) is an expert group in data anonymisation which includes members from academia, industry, patients and healthcare professionals. EMA established the TAG to help it to further develop best practices for the anonymisation of clinical reports.
For more information on the TAG's membership and responsibilities, see:
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 while the Agency processes these documents for publication. For more information on current publishing timelines, see Support for industry on clinical data publication.
On 16 July 2018 EMA published the first report on the implementation of the policy on the publication of clinical data.
The report covers one year from the launch of EMA's clinical data website on 20 October 2016. It lists the 54 regulatory dossiers published and the corresponding 50 medicines, which include orphan, paediatric, biosimilar and generic medicines.
The report also includes the results of a user survey of the clinical data website.
Regulation (EU) No. 536/2014 on clinical trials on human medicines (the 'Clinical Trials Regulation') provides a legal basis for the release of clinical trial results conducted in the European Union (EU) and authorised under this Regulation. It entered into application on 31 January 2022.
The table below compares EMA's policy on the publication of clinical data with the Clinical Trials Regulation in terms of their scope and information published.
| Clinical data publication policy | Clinical Trial Regulation | |
|---|---|---|
| Medicinal products covered | Centrally authorised products only | Investigational medicinal products regardless of whether they have a marketing authorisation |
| Clinical studies covered | Clinical studies submitted to the Agency in the context of a MAA, Art 58 procedure, line extension or new indication, regardless of where the study was conducted | Clinical trials conducted in the EU and paediatric trials conducted outside the EU that are part of paediatric investigation plans |
| Documents published | Clinical data (clinical overview, clinical summaries and clinical study reports) and the anonymisation report | All clinical trial-related information generated during the life cycle of a clinical trial (e.g. protocol, assessment and decision on trial conduct, summary of trial results including a lay summary, study reports for those trials in the system subsequently included in a marketing authorisation submission in the EU, inspections, etc.) |
| Publication channel | EMA clinical data website | Clinical Trials website |
| Date it applies | 1 January 2015 (MAA or Art 58 procedure) or 1 July 2015 (line extension or new indication) |
31 January 2022 |
| Publication from | October 2016 | 31 January 2022 |
The EU clinical trials register also provides publically available summary information on clinical trials conducted in the EU, and paediatric trials conducted outside the EU that are part of paediatric investigation plans. This is the publicly accessible part of the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database.