Strategies and Steps for the Accomplishment of Bioequivalence Regulations in Chile

Abstract

The process of bioequivalence policy implementation in Chile is presented. A chronological description of the regulatory bodies and tools to help fulfilling this legal requirement as well as the methodology to select drugs and their drug products subject to demonstrate bioequivalence is presented. Also, it is depicted the strategies used by health authorities to implement this new drug policy in order to not affecting drug product availability, increasing generics penetration in the pharmaceutical market and improving access to medicines both in the public and private healthcare system as well. Overall, it is expected that the implementation of the bioequivalence policy would contribute to health expenditure containment allowing redirecting the health budget to other sanitary needs as the most important challenge to come.