Raising the bar for market authorisation of new drugs.

Calls are increasing for manufacturers to provide evidence of comparative efficacy of new drugs at the time of regulatory approval. However, drug manufacturers maintain that doing so would create unrealistically high barriers for market entry and deter innovation. At a time of a perceived productivity crisis in the drug industry, many claim that stricter market authorisation regulation will be detrimental to the development of new drugs. We review the historical effect of regulating market authorisation and examine the benefits and risks of raising evidence standards by requiring evidence of non-inferiority for market entry. What’s the hype?