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In today’s global pharmaceutical ecosystem, one critical question continues to shape regulatory science:

Can data from one population truly represent another?

This question lies at the core of ethnic factors — the physiological, genetic, and cultural variables that influence how different populations respond to medicines.
Regulatory authorities, including Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), have long recognized that population-specific data is essential to ensure both efficacy and safety.

Ethnic factors impact:

  • Pharmacokinetics (PK): How the body absorbs, distributes, metabolizes, and excretes drugs.
  • Pharmacodynamics (PD): How a drug interacts with biological systems.
  • Genetic polymorphisms: Variations in metabolizing enzymes like CYP2C19 or CYP2D6, which can affect drug response.
  • Lifestyle and diet: Regional habits that influence treatment outcomes.

To address these differences, the ICH E5 guideline introduced the concept of bridging studies — allowing sponsors to use existing global clinical data while generating targeted local evidence to justify extrapolation.
This approach balances innovation with patient safety, particularly in markets like Japan, where pharmacogenomic sensitivity and localized clinical assurance are key to regulatory approval.

Understanding ethnic factors is not just a regulatory requirement — it’s a cornerstone of scientific integrity and patient trust.

To learn how Japanese clinical data strengthens global comparability and how Freyr Japan helps global sponsors navigate PMDA requirements, read our next blog:
The Necessity of Japanese Clinical Data: Ensuring Comparability of Efficacy Between Japanese and Caucasian Populations