Bioanalysis Zone

Implications of differences in bioanalytical regulations between Canada, USA and South America

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“…a growing challenge of the past decade has been additional country-specific and regional regulations…”

Providing a single set of standard operating procedures for method validation and sample analysis that meet the requirements of multiple countries is becoming a growing challenge to bioanalytical groups supporting the development of new drugs intended for global use. Over the past 20 years, pharmaceutical companies are seeing the need to change from a USA–Canada–EU–Japan primary focus for their new drug applications to one that includes other countries and regions with emerging markets and growing demand [1,2]. To survive in today’s market requires companies to understand not only the market pressures in each country, but also the regulations.

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