On December 2nd, FIC sent to the Medicines and Medical Devices Agency of Serbia (ALIMS) the comments for improving the Rulebook on the Contents of the Application, and/or Documentation on the Approval of Clinical Trials for Medicines and Medical Devices, as well as the Method of Implementation for Clinical Trials of Medicines and Medical Devices. The main FIC comment is to provide the precise list of documents needed to submit to the Serbian Ethical Committee EOS for the non interventional postmarketing surveillance. It was explained that the Covid-19 pandemic had significant impact on the area of clinical trials in Serbia, EU and worldwide, with the risk that the vast majority clinical trials be limited or canceled, and delayed for the post-covid period. The European Commission and EMA reacted with the relevant Guidance on management of clinical trials during the Covid-19 pandemic. The FIC proposal, containing 31 concrete proposals, can be found here.