title: Implications of differences in bioanalytical regulations between Canada, USA and South America.
abstract: To complete globally, pharmaceutical companies desire to use bioanalytical data and reports as a single version for all filings; not revising for specific countries or regions. Historically, this meant following the US FDA and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidance/guidelines; finding them sufficient to achieve global acceptance. However, a growing challenge of the past decade has been additional country-specific and regional regulations that have been released. The differences between the bioanalytical regulations among countries have been recognized as a challenge to the pharmaceutical industry and its CRO partners. Harmonization of the regulations at a global level has been the subject of a number of recent articles and editorials, and the topic has been vigorously discussed at several conferences over the past year. Since all have been in agreement about the need to harmonize regulations, this article will not focus on harmonization but rather it will provide a comparison of the USA/Canadian regulations versus those of South America, in particular Brazil, noting the additional work needed to achieve compliance with country-specific regulations. All countries discussed have specific guidance or regulations on clinical bioequivalence studies, and due to the higher standards for these studies, the regulations for bioequivalence studies will be used as the basis for comparison in the article.
authors.affiliation: Bioanalytical Sciences, Bristol-Myers Squibb, Co. Route 206 and Province Line Road, Princeton, NJ 08540, USA. mark.arnold@bms.com
authors.forename: Mark E
authors.initials: ME
authors.lastname: Arnold
mesh_terms: D001938:Brazil; D002170:Canada; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D006801:Humans; D007391:International Cooperation; D004364:Pharmaceutical Preparations / Q000592:standards*; D013020:South America; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations