EMA has developed detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data.
EMA first published guidance in March 2016 and is updating it on a regular basis. Current and past versions of the guidance as well as the list of changes between published versions can be found 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 as regards 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);
- anonymising clinical reports (in chapter 3), including a template for the anonymisation report (in annex 1.2);
- 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:
EMA also held a series of briefings and consultations to support stakeholders in implementing the policy:
- 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.
Initial stages of implementation
During the initial operational start–up phase, EMA will contact companies individually approximately 2 months before they are expected to submit their redaction proposal document package for the product in question, rather than adhering to the timelines in the guidance.
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 office 5 months prior to 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.
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