Eficiência regulatória: Análise de sobrevivência aplicada a trajetória de registro de medicamentos genéricos

A new and challenging scenario for drug analysis and registration has been gradually incorporated into the routine of the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitára - Anvisa) by the Brazilian pharmaceutical industry. This text calculates how long the registration process for generic drugs lasts and analyzes the most important issues involved. We discuss the mains concepts involved in regulation of generic and similar drugs such as: original generic drugs, prioritized generic drugs, and clone drugs. The sample analyzed is composed of 323 generic drugs registered in 2010. A survival model involving the most important parameters in the registration process was estimated. The main results are that the average registration time is 626 for non-prioritized drugs and 429 for prioritized ones. Drugs suffering on location audits were analyzed on average in 323 days and drugs with temporary process suspension at the request of the industry were analyzed in 1018 days on average. An unexpected result is that 26% of the audited drugs were suspended at the request of the industry after the audits. We conclude that these results point to a window of opportunity for rational changes in the registration process for drug copies in Brazil focused on audits and the quality of information provided by the pharmaceutical industry.