On 05 October 2015, the EMA signed the Appendix, on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014”. In this document, the EMA introduces a new categorisation of clinical trials. Trials that are not intended to treat, prevent or diagnose a condition (including Phase 1, bioequivalence, bioavailability and biosimilarity trials) are defined as “Category 1” trials.
The Appendix provides sponsors with the unique opportunity to combine compliance with recognised transparency measures with an assured protection of their IP and patent rights. The Appendix achieves this by setting straight-forward and universally acceptable rules that allow up to 30 months after the end of a trial for publication of Category 1 trials’ information and summary results.
A copy of the Appendix on disclosure rules can be found here.