New Regulations Will be More Strict
European Medicines Agency announced renewal of clinical trial rules. The regulator together with European Commission and Representatives of European Union member states make a new list of documents required to obtain an approval for first studies of drugs in humans. Requirements to clinical trials will become stricter. The decisionwas taken after an accident that occurred last January, when six volunteers were injured during studies of an investigational drug by Portugese Bial. One of the volunteers died.
Accidents are quite rare during clinical trials, however, the General Inspection of Social Affairs in France (IGAS) and Temporary Special Scientific Committee (TSSC) undertook a large investigation. The material collected will be taken into account for update of EMA rules for conduct of clinical trials.