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ノート :
Briding is an important element of the globalization of drug development and evaluation. All parties benefit from policies that can simplify and speed the evaluation and introduction of new drugs. Data requirements for approval of new drugs in different region should allow use of relevant data from foreign regions. Ultimately, however, the regulatory body must employ standards for drug approval that protect the public against adverse effects that are specific that region’s population and that screen out ineffective drugs.
Thesis: Both safety and efficacy are critical issues in drug approval based partially on data from foreign regions. Safety is of obvious concern. If a drug proves to have new or more frequent adverse effects in the new region, patients will bear the burden of those adverse effects. If a drug proves not to be effective in the new region, however, its approval will lead to the use of the drug in the new region, denying patients the opportunity to receive other effective treatments. This suggests that higher standards regarding evidence for efficacy are appropriate if alternative treatments are available.
