In 2014 European regulators began inspecting drugmakers for compliance with new postmarket
reporting and surveillance requirements for drugmakers. They also have raised the bar
for winning a drug approval at the European Medicines Agency, which now requires drugmakers
to design and implement a substantial safety plan for each drug. While drugs have always
had to meet safety regulations, the new rules demand much stronger and thoroughly prepared
pharmacovigilance activities on the part of drugmakers.