March 2018: Brazil Regulatory Updates

The country has a large number of treatment-naïve patients that are getting older and living longer, which affect the epidemiologic profile, increasing the prevalence of chronic diseases. Furthermore, the strong investigator-patient relationship increases the adherence and recruitment rates that rank them as top recruiters of trials they conduct.

In spite of the fact that discussion to change the ethics approval process is still open, approvals currently take 90 days. Combined with the new ANVISA timelines, which is already in place, the total time frame for approval can vary from 90 to 180 days. It means that a study can start at least six months earlier than the previous scenario, even before a final definition about the CONEP’s new approval system.

Faster assessment of clinical trials and getting rapid approvals in Brazil can bring several advantages for pharma and biotech companies. The potential to be one of top contributors to achieve the study targets could ultimately help save costs and reduce the length of clinical trials. Moreover, it also provides a great possibility for doctors and health professionals to work with new medicines in an early phase of development.

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