EMA updates clinical data publication guidance with mandatory anonymisation templates
The European Medicines Agency (EMA) has published Version 1.5 of its external guidance on the implementation of Policy 0070, which governs the publication of clinical data for medicinal products for human use. The updated guidance clarifies and consolidates procedures relating to the submission, anonymisation, and redaction of clinical reports submitted in centralised marketing authorisation procedures. It provides revised instructions for applicants and marketing authorisation holders (MAHs) on the preparation of redacted and anonymised clinical documents, including the use of mandatory templates for justification tables and anonymisation reports.