EMA Policy on the Publication of Clinical Data
Sponsors and marketing authorization holders (MAHs) in Europe have the option, to a certain extent, of marking the data and information they submit as not intended for the public and informing the EMA accordingly. To this end, the EMA has developed detailed guidelines for pharmaceutical companies on the requirements for compliance with its guidelines on the publication of clinical data.
The EMA has published a revised Version 1.5 of the guideline on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. Due to the extensive updates in all chapters of the guideline, the EMA has simultaneously published a summary of the revised content in this guideline as an aid for the healthcare professionals concerned and to present the changes.
The EMA has set up a dedicated website regarding the publication of clinical study data, where further information can be found. For more details please see the "External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use".
Related GMP News
17.07.2025ICH E20 Draft Guideline on Adaptive Design for Clinical Trials
17.07.2025Update on ICH Guidelines E21 & E22
17.06.2025EMA Implementation of ICH E6, M11 & M12
03.04.2025Update on the ICH M11 CeSHArP Technical Specification
03.04.2025EU Map to Clinical Trials