Regulatory Reform
Trench Rossi e Watanabe / Brazil
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 GBP 119, here.
1. Are there proposals for reform or significant change to the healthcare system?
There are plenty of Law projects under discussion. Before National Congress, there is Bill No. 667/2021, which provides for the creation of Risk Sharing Agreement for the incorporation of new health technologies.
Furthermore, there are several relevant themes included on ANVISA’s Regulatory Agenda of 2021-2023, such as: (i) review of Resolution RDC No. 98/2016, which provides OTC drugs; (ii) review of GMP and Certificate of Good Practices for Distribution and Storage; (iii) review of the drug labelling requirements; (iv) review of Resolutions RDC 9/2015 and 10/2015, which provides for clinical trials with drugs and medical devices, respectively; (v) review of the requirements for proof of safety and efficacy of the synthetic drugs (Resolution RDC 200/2017); (vi) use of analysis performed by Equivalent Foreign Regulatory Authorities for regularization of products before ANVISA (GGMED); (vii) expanded Access to Medical Devices; (viii) reprocessing of medical devices; (ix) Good Practices for pharmacies; among others.
On March 30, 2021 ANVISA published the Resolution RDC No. 657/2022, which provides for the regularization of software as medical device (SaMD). It will come into force on July 1st, 2022.
2. When are they likely to come into force?
Unfortunately, it is not possible to predict if and when the Bill will come into force. Nonetheless, ANVISA’s regulatory agenda is planned to be concluded until 2023.
