On 23 April 2024, the Federal Senate approved Bill 6,007/2023, which originated as Bill 200/2015, and which generated intense debate among all those involved in the clinical research ecosystem. While the bill was supported by the economic sectors and part of academia due to the stability and security it brings to clinical research in Brazil, various social segments, part of academia and government authorities who are members of the system raised concerns about the possibility of weakening national ethical guidelines and dismantling the CEP/CONEP system.

The National Health Surveillance Agency published Resolution RDC No. 625/2022, which provides the minimum requirements related to the marketing authorization holders’ obligation to communicate the implementation of a drug recall to the competent authorities and consumers. This is in case there is sufficient evidence or proof of quality deviation resulting in risks or consequences to health, as well as due to the cancellation of registration related to safety and efficacy.

The Brazilian National Health Surveillance Agency (“Anvisa”) published Resolution RDC No. 497/2021 (“RDC 497/2021”) setting forth the new administrative procedure for obtaining the Good Manufacturing Practices Certificate, as well as the Good Distribution and/or Storage Practices Certificate. RDC 497/2021 modifies the general conditions for certification, as provided for in its Chapter II, to facilitate the certification process.

The Brazilian federal government published on 10 March: (a) Federal Law No. 14,124/2021, for providing for exceptional measures related to the acquisition of vaccines and other services related to COVID-19; and (b) Federal Law No. 14,125/2021, for providing for liability and adverse events of post-vaccination against COVID-19, and for the acquisition and distribution of vaccines by private entities and federative entities (state or municipality).

In brief Life sciences, regulatory and intellectual property COVID-19 suvey on: market access clinical trials IP risks telemedicine Contents Market access Clinical trials IP risks  Telemedicine Market access (a) How has the regulator in charge been addressing the urgent needs for medicines, medical devices and medical supplies?  Has the focus…