Regulatory Affairs

EMA Work Program Shows Uptick in Pharmacovigilance, Risk-Management Activities

European drugmakers can expect a more globalized European Medicines Agency, according to the regulator’s 2014 work program, which includes an increase in joint inspections with international counterparts, improving the agency’s support for companies in early-stage drug development and completing the rollout of the massive new pharmacovigilance requirements begun in 2012. Read More

EMA Launches ‘Adaptive Licensing’ Pilot

The European Medicines Agency (EMA) has launched a new pilot program intended to speed new therapies to patients via a process that authorizes products for use by targeted populations in stages. Read More