A brief insight into upcoming regulatory reforms in Brazilian pharma. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for USD 99, here.
1. Are there proposals for reform or significant change to the healthcare system?
There are plenty of Law projects under discussion. Before ANVISA there are two relevant rules under public consultation, one to regulate Good Practices for Pharmacovigilance and other one to regulate Patient-Specific and Custom-made Medical Devices.
2. When are they likely to come into force?
Unfortunately, it is not possible to predict and it seems to us that it is not on the authorities’ radar at this moment in Brazil.