Support for industry on clinical data publication

The European Medicines Agency (EMA) has developed detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data.

EMA intends to gradually resume clinical data publication from September 2023, having temporarily suspended this activity for all products except Treatments and vaccines for COVID-19.

For more information, see: 

• Clinical data publication
• Clinical Data Publication (Policy 0070) re-launch - EMA webinar

EMA will recommence sending 'invitation letters' to stakeholders and will contact applicants individually prior to the re-launch of clinical data publication.

In this section

• External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use

Guidance and templates

EMA first published guidance in March 2016. The current and past versions of the guidance, as well as the list of changes between published versions, can be found by accessing the link below:

• External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use

The external guidance provides further information on:

• the scope of the policy regarding clinical reports submitted as part of other regulatory procedures, informed consent applications and duplicate marketing authorisations, as well as definitions (in chapter 1);
• the procedural aspects related to the submission of clinical reports (in chapter 2);
• anonymisation of clinical reports (in chapter 3);
• identification and redaction of commercially confidential information in clinical reports (in chapter 4).
   

Anonymisation report form template

*If after clicking on ‘View’ the template is not displayed in your browser, please use the browser functionality ‘Save’ to download the template and use Adobe Acrobat to open it from your device. 

Anonymisation report form instructions

Reference Number: EMA/482639/2023

• how to identify and redact commercially confidential information in clinical reports (in chapter 4).

Companies should provide justifications for redactions of commercially confidential information by using the following template:

Justification table templates

Reference Number: EMA/152360/2016 rev.1

EMA has developed a question-and-answer (Q&A) document to expand on issues addressed in the external guidance and in discussions with applicants. It addresses a number of questions concerning procedural matters including timelines, commercially confidential information and the anonymisation process. For more information, see:

Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)

Reference Number: EMA/14227/2017 Rev. 3Summary:

Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)

It will be revised regularly to reflect updates.

Stakeholder meetings

EMA held a series of briefings and consultations to support stakeholders in implementing the policy:

• Industry associations webinar: update on the implementation of European Medicines Agency policy on publication of clinical data - Policy 0070 (29/01/2018)
• Update on the implementation of policy on publication of clinical data (Policy 0070) – Industry associations webinar (29/06/2017)
• Update on the implementation of EMA policy on publication of clinical data (Policy 0070) and draft revisions guidance to industry - industry associations webinar (23/03/17)
• Update on the implementation of EMA policy on publication of clinical data (Policy 0070) and proposed revisions to the guidance to industry – Industry associations webinar (9/12/2016)
• 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 available video recordings are provided on the meeting pages.

Micro, small and medium-sized enterprises

Micro, small and medium-sized enterprises (SMEs) are entitled to a free redaction tool license valid for a period of 12 months to allow companies enough time to prepare the final redacted version. The application letter template for the free redaction tool is available in annex 1 of the external guidance.

SMEs should contact the SME office5 months priorto the CHMP opinion to apply for the free redaction tool license. The SME office can also provide further guidance on the EMA's policy on the publication of clinical data.