Support for industry on clinical data publication

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 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.

This article was originally posted on the EMA website.