The European Medicines Agency (EMA) bases its scientific opinions on the results of clinical trials carried out and submitted by pharmaceutical companies. Under EMA's policy on the publication of clinical data, the Agency proactively publishes the clinical reports submitted under the centralised marketing authorisation procedure for human medicines. The policy entered into force on 1 January 2015 and is currently being implemented.
By proactively publishing clinical data, EMA intends to help:
- avoiding duplication of clinical trials, foster innovation and encourage development of new medicines;
- building public trust and confidence in EMA's decision-making processes;
- academics and researchers to re-assess clinical data.
In October 2014, the Agency published its final policy on publication of clinical data:
- European Medicines Agency policy on publication of clinical data for medicinal products for human use
- Q&A on the European Medicines Agency policy on publication of clinical data for medicinal products for human use
The policy applies to clinical reports contained in all initial marketing-authorisation applications submitted on or after the policy's entry into force on 1 January 2015. It also applies to applications submitted on or after 1 July 2015 to vary a marketing authorisation for an extension of indication or a line extension.
EMA will publish the reports 60 days after a decision on the application has been taken. The publication of the first reports is foreseen for mid-September 2016.
The adoption of the policy followed extensive consultations by EMA with patients, healthcare professionals, academia, industry and other European entities. For more information on the consultation exercise, see Background to the policy on the publication of clinical data.
In March 2016 EMA published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data:
- External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use
The document provides guidance on:
- the procedural aspects related to the submission of clinical reports;
- how to identify and redact commercially confidential information in clinical reports;
- anonymising clinical reports.
The clinical data covered by the policy is the same as that submitted for scientific review, but companies must submit a proposed redacted version with a justification of any commercially confidential information proposed for redaction. They must also anonymise personal data.
Companies should provide justifications for redactions of commercially confidential information by using the following table:
EMA may require further clarification or justification, which companies must address. The Agency publishes the final redacted version.
EMA expects to make further updates to the guidance.
Support during implementation phase
In 2015 EMA consulted stakeholders extensively, as well as the European Ombudsman and European Data Protection Supervisor.
EMA also held a series of briefings and consultations to support stakeholders in implementing the policy:
- Second stakeholder meeting on the implementation of the European Medicines Agency's policy on publication of clinical data for human medicines (7/9/2015)
- Meeting on redacting commercially confidential information (CCI) in clinical reports and anonymising clinical reports for the purpose of publication (6/7/2015)
- Current status of European Medicines Agency policy on publication of clinical data - Stakeholder webinar (24/6/2015)
Agendas, meeting reports, presentations, question-and-answer documents and video recordings (when available) are provided on the meeting pages.
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- European Medicines Agency policy on publication of clinical data for medicinal products for human use (02/10/2014)
- European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use) (30/11/2010)
- Heads of Medicines Agencies / European Medicines Agency guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application: Release of information after the granting of a marketing authorisation (27/03/2012)
- Principles to be applied for the implementation of the Heads of Medicines Agencies / European Medicines Agency guidance on the identification of commercially confidential information and protected personal data in marketing-authorisation applications (27/03/2012)