Improving transparency of drug regulatory decisions

Marketing authorisation is a critical regulatory decision that determines whether a medicine can enter the market. This decision is based on an assessment of the medicine's benefit-risk balance and the strength of the supporting evidence. Regulatory bodies must weigh multiple factors, including clinical benefit, methodological robustness, evidentiary uncertainty, and unmet medical need. The process involves expert judgment, and the same evidence may be interpreted differently. Although marketing authorisation is a binary verdict, the committee behind the decision may be divided. Experts may disagree on how benefits, risks, and uncertainties should be weighed, but such disagreement is not always visible in the final regulatory decision. At the European Medicines Agency (EMA), applications are assessed by the Committee for Medicinal Products for Human Use (CHMP). Decisions are reached by consensus where possible, otherwise by an absolute majority of the voting members.