ANSM has just announced that they changed the procedure for reporting of adverse events from clinical trials.
It is no longer required to attach a cover letter with the submission of adverse event reports in France, but they still require manual submission of CIOMS I reports through specially formatted email messages.
EU, pharmaceutical industry and the national agencies – including France – as well as ICH and ISO have spent the last 20 years and an enormous amount of money on developing and implementing an automated real time system to manage the huge amount of data. This is the Eudravigilance database and the secure ESTRI gateway.
EMA has operated this a very capable system for the last 10 years for reporting of adverse events in both clinical trials and post market which can communicate electronically – very efficient, encrypted and highly secure through global standards. That system is used by other European Union members to ensure one common database for drug safety reports where all member states have access.
For unknown reasons ANSM decided to abandon decades of efforts in the European Union and require manually formatted cover letter with old fashioned CIOMS I forms for reporting. So for each report that is automatically formatted and submitted to the EU database every pharmaceutical company have to write a separate cover letter, generate a CIOMS I form and generate an email with a specific heading so it is easy for ANSM to identify the case. All of which could have been available for them in real time at no cost or effort as the Eudravigilance database is already available for them.
Sorry about the negative twist, but it is hard to see so much wasted effort – here is the announcement from ANSM about their improved process: ANSM explanatory note