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The role of drug regulatory agencies is to protect and promote public health. In everyday practice, this broad mandate translates into two distinct objectives: first, into an obligation to protect patients against ineffective or harmful drugs and, second, to protect patients against the consequences of untreated disease. The first objective results in a gatekeeper function and obliges regulators to apply stringent standards of assessment and to deny marketing authorisation where deemed necessary. By contrast, the second objective requires regulators to support and enable drug development – with a view to ensuring that patients have access as early as possible to safe and effective drugs.