Module 9 2021

22/03/2021

REFERENCE PRODUCT

•EU and US allow a sponsor to use data derived from animal or clinical studies comparing a proposed product with a non-U.S.-licensed product; often 3-way PK bridging is required. •Equivalent quality, safety and effectiveness to biotechnology applied drug already approved as a drug with a new active ingredient in Japan

•China requires that reference product is sourced from the same manufacturer that supplies the Chinese market

•Most other countries are satisfied by CMC bridging data or allow sourcing of reference product from defined regions

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NEED FOR DATA IN LOCAL POPULATION

US: Local patients not essential but justify studied population representative of US population EU: Local patients not essential but justify studied population representative of EU India : variable, figure 100 Indian patients often cited Russia : variable, often OK to include Russian patients in trial or perform small separate study in Russia Mexico : request some local patients to be included Japan : require exposure of some Japanese subjects – see following slide China : full program in China no longer required BUT need to justify extrapolation from non Chinese population and likely need some patients ex China - see following slide

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