[Perspectives] Current regulatory status in China of drugs withdrawn from the US FDA accelerated pathway: implications for regulation globally

In 1992, in an effort to bring novel drugs to market more quickly and meet patient needs in a timely manner, the US Food and Drug Administration (FDA) pioneered an accelerated approval initiative on the basis of surrogate endpoints that are reasonably predictive of clinical benefit for the treatment of serious or life-threatening diseases.1 By contrast to regular approval, accelerated approval requires post-market confirmatory clinical trials to establish the clinical benefit of the drug, then a decision is made as to whether the approval should be converted to a traditional approval or whether the drug should be withdrawn from the market.