30/10/2023
On October 27, 2023, the Brazilian Health Regulatory Agency (Anvisa) published Public Consultation 1,210/2023, which aims to revise RDC 38/2013, which regulates expanded access programs, compassionate use and post-study medicine supply. The Public Consultation will be open from November 3, 2023 to January 2, 2024 for contributions. During the 10 years that the standard has …
24/10/2023
On October 23, 2023, the Brazilian Health Regulatory Agency (Anvisa) published in the Federal Official Gazette (DOU) RDC 823/2023, which establishes the pilot project for implementing the optimized evaluation procedure, based on risk criteria in applications for registration and post-registration changes of medicines. The Resolution comes into force on November 1, 2023. The RDC’s draft …
16/10/2023
Nossa equipe multidisciplinar de Soluções Climáticas mapeou as atualizações regulatórias recentes de 2023 que, em síntese, impactam em maior necessidade de análise e monitoramento de critérios socioambientais e climáticos no setor financeiro (e, em especial, para o agronegócio). As alterações (Atualização MCR nº 722 de 30 de agosto de 2023) envolvem novas normas do Conselho …
05/10/2023
Anvisa’s Public Consultation 1.206/2023 was published in the Official Federal Gazette (DOU) on October 4, 2023. The main objective is to amend the current regulation on biosimilar medicines, as well as to completely revoke Chapter V of RDC 55/2010, which establishes the registration of biological products through comparability – Biosimilars. In general terms, the goal …
27/09/2023
On September 26, 2023, Brazil’s Federal Government published the Brazilian Strategy for the Development of the Health Economic-Industrial Complex (CEIS). Through Decrees No. 11.714/2023 and No. 11.715/2023, the President of the Republic, Luiz Inácio Lula da Silva, established the main objectives of the initiative and created the Deliberative Committee and the Technical Evaluation Commission to …
06/09/2023
The National Health Surveillance Agency (Anvisa) has been striving to promote regulatory harmonization in recent years. In this regard, the Collegiate Board Resolution RDC 741/2022 has introduced authorization for optimized analysis through reliance mechanisms. However, RDC 741/2022 stipulates that each technical area of the Agency must define specific requirements for these optimized procedures, indicating the documents to …
06/09/2023
The National Data Protection Authority (ANPD) invites the general public to submit suggestions and comments on the Preliminary Study – Legitimate Interest (click here). The purpose of this consultation is to facilitate public discussion to assist in the future development of a Guidance Manual on the legal basis for the processing of personal data by the data …
01/09/2023
Published on August 21, Anvisa’s RDC No. 811/2023 comes into force today (September 1, 2023). The new resolution changed the following rules: Anvisa’s RDC No. 204/2017, which sets out the priority category for applications for registration, post-registration, and prior consent for clinical research of medicines; and Anvisa’s RDC No. 205/2017, which establishes a special procedure …
25/08/2023
On August 24, 2023, the Acting President of the Republic, Geraldo Alckmin, sanctioned Law N°. 14.654/2023, which adds a provision to the Organic Health Law (Law N°. 8.080/1990). The new law mandates various levels of the Unified Health System (“SUS”) to disclose on their websites the stocks of medicines in public pharmacies under their management. …
23/08/2023
The advent of RDC 751/2022 was important for the medical devices sector, as it updated Brazil’s regulatory framework after 2 (two) decades of validity. However, despite all the discussion that headed its publication, the Brazilian Health Regulatory Agency (Anvisa) needed to update it quickly to bring more legal certainty to the regulated sector, as well as to …