What is the best drug regulation system?

Proponents argue that a regulator learns most about a medicine after it is licensed, when it meets a population far larger and more varied than any trial, so the system should be built to collect and act on reports of harm in ordinary use.

This position puts the weight of regulation before approval, on the design and conduct of trials, holding that a decision about whether a medicine works and is safe can only be as sound as the evidence gathered to support it.

On this view the best system concentrates on how medicines are actually made, inspecting facilities, tracing supply chains and enforcing manufacturing standards, on the grounds that an approved drug is only as good as the batch that reaches the patient.