ANVISA (the Brazilian Health Regulatory Agency) has announced a significant initiative for the healthcare sector: the creation of the Technical Chamber for Clinical Research on Medicines and Medical Devices, known as Catepec. With this new chamber, ANVISA aims to modernize, streamline, and enhance the efficiency of clinical research regulation and evaluation in Brazil, promoting greater safety and quality in the development of medicines and medical devices.
Catepec will bring together a highly qualified group of specialists from diverse fields who will be responsible for evaluating clinical trial protocols (supporting both registration and post-registration processes). The technical insights provided by the chamber will help refine the decision-making process and establish a standard for the participation of external stakeholders in this process.
As a result, the approval process for new medical technologies will become more agile, transparent, and evidence-based, benefiting both the industry and patients alike.
To ensure that this technical chamber is composed of the most skilled professionals, ANVISA has issued a public call for specialists interested in joining Catepec’s board. These professionals can participate as members with a three-year mandate, as part of specific working groups, or as invited experts to discuss particular topics. Applications are open for 30 days, and interested parties can apply through an electronic form available in the public notice
(https://pesquisa.anvisa.gov.br/index.php/517274?lang=pt-BR).
This is a unique opportunity for healthcare professionals who wish to contribute to the development and advancement of clinical research in Brazil, participating directly in the regulatory process that shapes the future of medicines and medical devices in the country.
For companies operating in the healthcare sector, this new development has the potential to accelerate the approval time of new products and to help ensure that regulatory decisions are increasingly grounded in cutting-edge science.
If you have any questions about these new developments, please feel free to contact us. We will be glad to help you.