The ICH E5 guideline “Ethnic factors in the acceptability of foreign clinical data” and E17 guideline “General principles for planning and design of multi-regional clinical trials” present harmonized methodologies to efficiently develop drugs in multiple regions while considering ethnic differences in drug responses.
While the regulatory authority of a country is expected to judge if its jurisdictional population reacts uniquely to the tested drug to warrant inclusion in a Multiregional Clinical Trial (MRCT), the science often does not inform the judgement, for want of necessary evidence—especially in the earlier phases of development. Instead, the judgement often reflects a country’s policies on drug development in general. Recent development of anti-COVID-19 agents affords some relevant insights.
Regulators’ Responsibilities In Relation to Ethnic Differences
International harmonization of pharmaceutical regulations generally assumes that a good drug retains its virtue everywhere in the world, and its usefulness can be proven with a single crosscutting data set. The E5 and E17 guidelines uniquely allow, however, that a drug beneficial to one population may not offer the same benefits to others, and they justify country/ethnicity-specific data in the form of a bridging study or inclusion in a MRCT. It is ultimately each country’s regulatory authority that responsibly passes judgement on its population’s uniqueness in reaction to drugs, requests the clinical data, and reviews the market authorization application (MAA)…