Module 9 2024

05/09/2024

Reference Product Requirements

• 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

The Organisation for Professionals in Regulatory Affairs

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Requirements for Local Population Clinical Data

⚫ US:

Local patients not essential but need to justify studied population representative of US population Local patients not essential but need to justify studied population representative of EU population

⚫ EU:

⚫ India : Variable, figure of 100 Indian patients often cited

⚫ Japan : Recently removed requirement for exposure of Japanese subjects

⚫ China : Full program in China no longer required BUT need to justify extrapolation from non Chinese population and likely need some patients ex China

The Organisation for Professionals in Regulatory Affairs

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