On Friday, February 7^th, the Drug Market Regulation Chamber (“CMED”) published in the Brazilian Federal Register the Notice of Call #1/2025, inviting society to offer contributions of data, information, opinions and suggestions on the pricing criteria for advanced therapy products, in order to support the preparation of the Regulatory Impact Analysis, before CMED drafts the respective regulatory instrument on specific aspects related to the pricing criteria for advanced therapy products.

According to CMED, the Notice of Call was published due to the complexity of advanced therapy products and the time gap between the pricing rule (Law #10,742/2003), published more than 20 years ago, and the marketing approval rule for these products, published by ANVISA (the Brazilian FDA) in 2021 (ANVISA’s Resolution #505/2021), which results in these products being categorized as omitted cases by CMED. Therefore, to promote greater transparency, public integrity, legal certainty and regulatory alignment with best regulatory practices, the Chamber understands that it is necessary to establish criteria for the pricing of these products.

Contributions to the Notice of Call will be made through the electronic form available at http://pesquisa.anvisa.gov.br/index.php/192711?lang=pt-BR. Submissions can be made between February 10, 2025, and March 28, 2025, and the results will be published in a report on the website of CMED.

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