إجراء مقترح من تشيلي: الأدوية واللقاحات

The notified document is an update to the current regulations based on the harmonized technical guideline 'ICH M9 on Biopharmaceutics Classification System-Based Biowaivers', drawn up by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.Technical aspects not covered by that guideline have been supplemented by incorporating bioequivalence guidelines issued by leading international agencies and bodies, including the European Medicines Agency, the Food and Drug Administration and the World Health Organization. In addition, this update takes into account the theoretical and practical experience of the Chilean Public Health Institute.