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Clinical data publication
As of October , the European Medicines Agency (EMA) publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralised procedure. This is based on EMA's flagship policy on the publication of clinical data.
By proactively publishing clinical data, EMA intends to help:
- avoid duplication of clinical trials, foster innovation and encourage development of new medicines;
- build public trust and confidence in EMA's scientific and decision-making processes;
- academics and researchers to re-assess clinical data.
EMA has developed extensive guidance for industry to facilitate compliance with this policy.
On 5 December , the Agency suspended the publication of clinical data as a result of the implementation of the third phase of EMA's business continuity plan and it remains suspended due to ongoing business continuity linked to the COVID pandemic. EMA is publishing clinical data for COVID medicines in line with its exceptional transparency measures for treatments and vaccines for COVID
How to access the clinical data
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.
What clinical data EMA publishes
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:
- the clinical overview, providing a critical analysis of the clinical data in the submission package, including the conclusions and implications of the clinical data;
- the clinical summary, which provides a detailed factual summarisation of all the clinical information submitted;
- the study reports on the individual clinical studies;
- three appendices to the clinical study reports, namely the study protocol, the sample case report form used to record information on an individual patient, and documentation of the statistical methods used to analyse the data.
These documents correspond respectively to modules , and of the common technical document (CTD).
EMA revised its policy on publication of clinical data in March , 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.
For COVID 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:
Exclusions
The policy does not apply to:
Preparing the data for publication
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.
Technical anonymisation group
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:
Timelines for publication
EMA aims to publish the clinical reports as per the following timelines:
Please note that there will be some delay in publishing clinical data submitted in and while the Agency processes these documents for publication. For more information on current publishing timelines, see Support for industry on clinical data publication.
First report on the implementation of the policy on the publication of clinical data
On 16 July 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 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.
Comparison with the Clinical Trial Regulation
Regulation (EU) No. / on clinical trials on human medicines (the 'Clinical Trial Regulation') provides a legal basis for the release of clinical trial results conducted in the European Union (EU) and authorised under this regulation. It enters into force in
The table below compares EMA's policy on the publication of clinical data with the Clinical Trial 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 publication website | Future EU portal and database |
| Date it applies | 1 January (MAA or Art 58 procedure) or 1 July (line extension or new indication) | Planned for end |
| Publication from | October | Planned for end |
Until the Clinical Trial Regulation enters into force, the EU clinical trials register provides publically available summary information on clinical trialsconducted 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 EU clinical trials database (EudraCT). As of 21 July , it is mandatory for trial sponsors to upload results of their trials on the public register.
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