Approval times and the safety of new Pharmaceuticals

摘要

Shortened approval times for new pharmaceutical substances might mean less thorough investigations into the efficacy and safety of each new substance entering the market, which might in turn cause the number of adverse drug reactions reported to the Swedish Medical Products Agency (SMPA) to increase. The purpose of this study was to analyze the relationship between approval times for new pharmaceuticals and the number of adverse drug reactions reported to the SMPA.