August 2022 Monthly Newsletter

The Eurasian Economic Union (EAEU), consisting of: Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia, are in the process of unifying the regulatory framework around the licensing of new pharmaceuticals and medical devices. The changes to the legislation seek to update the drug submission process ensuring that all registered medicinal products comply with the new standards by 2025.

Over the last few years, there have been multiple updates and amendments to the legislation surrounding the licensing process. Recent changes have affected the timeline for products currently in the registration process. In addition, the costs of new drug submissions, renewals and upgrades have gone up by a factor of two to threefold.

Brazil has a longstanding tradition and experience of performing clinical trials, with a good infrastructure of investigational sites, laboratories, and medical professionals. With its large and diverse population – over 200 million inhabitants – from different origins and ethnicities, and a high incidence of diseases prevalent in developed regions, the country offers favorable conditions to conduct trials across diverse medical fields.

However, before starting a clinical study, the Clinical Trial Application (CTA) must be evaluated by the National Health Surveillance Agency (ANVISA) and Ethical System. The historically long timelines required for these assessments represent one of the main reasons Brazil does not participate as actively as other nations in international multicenter studies.