As of October 2016, 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.
The Agency has developed extensive guidance for industry to facilitate compliance with this policy.
How to access the clinical data
What clinical data EMA publishes
EMA published its policy on publication of clinical data in October 2014 and it entered into force on 1 January 2015:
- European Medicines Agency policy on publication of clinical data for medicinal products for human use
- Questions and answers on the European Medicines Agency policy on publication of clinical data for medicinal products for human use
Under this policy, 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 2.5, 2.7 and 5.3 of the common technical document (CTD).
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 more information on the policy and its background, including the consultation exercise, see:
The policy does not apply to:
- 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.
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.
Call for experts in data anonymisation (new)
EMA has launched a public call for applications to join a technical anonymisation group to help the Agency to further develop best practices for the anonymisation of clinical reports.
The group will consider experience to date with the publication of clinical reports. In particular, it will assess:
- patient re-identification and any privacy risks in the light of new technological developments;
- the scientific utility of the published clinical data as a function of the anonymisation methodology used;
- whether secondary analysis of the clinical data can be successfully undertaken on anonymised data.
It will include representatives of academia, industry, patients and healthcare professionals with expertise in areas such as data protection, developing standards and guidance for anonymisation and re-analysis of clinical data. For more information see the terms of reference below.
Interested parties should send a curriculum vitae (CV) and declaration of interests to email@example.com by 28 April 2017.
For further information, see:
*If you have problems downloading the declaration of interests form, right-click and save the document locally on your computer before opening it.
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.
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 while the Agency processes these documents for publication.
Comparison with the Clinical Trial Regulation
Regulation (EU) No. 536/2014 on clinical trials on human medicines (the 'Clinical Trial Regulation') provides a legal basis for the release of clinical trial results conducted in the EU and authorised under this regulation. It enters into force in 2018.
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, inspections, etc.)|
|Publication channel||EMA clinical data publication website||Future EU portal and database|
|Date it applies||1 January 2015 (MAA or Art 58 procedure) or 1 July 2015 (line extension or new indication)||Expected October 2018|
|Publication from||October 2016||Expected in 2019|
Until the Clinical Trial Regulation enters into force, the EU clinical trials register 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 EU clinical trials database (EudraCT). As of 21 July 2014, it is mandatory for trial sponsors to upload results of their trials on the public register.
- Support for industry on clinical data publication
- Background to clinical data publication policy
- Documents from advisory groups on clinical-trial data
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- European Medicines Agency policy on publication of clinical data for medicinal products for human use (2014-10-02)
- Open clinical data - stakeholder quotes (2016-10-25)
- Policy 43: European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use) (2010-11-30)