Spring Intro 2023

30/03/2023

Back-up

MAA

Phase 1 Phase 2 Phase 3

Post Approval

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How ? Regional Clinical Trials

Many ROW authorities don’t have regulatory guidance defining clinical data requirement or evaluation criteria but…..

A number of countries have regulatory requirements for local country specific or regional clinical trial data • Ethnic factors  efficacy and safety different in certain populations • Protection of local pharma manufacturers / barriers to global pharma companies • Provide opportunity for local clinical experience • Currently recommended/required for China, Korea, Taiwan, India, Vietnam, Philippines, Russia, Mexico, Nigeria • Generally Phase 3 data required, presented in country specific Clinical Study Report or Bridging Report • Demonstrate locally generated clinical data is consistent with global dataset • OR…for some countries - involve sites in global trial

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