CMED calls for contributions on pricing regulation of advanced therapy products
On Friday, February 7th, the Pharmaceutical Market Regulation Chamber (CMED) published in the Federal Register the Notice of Call #1/2025, which aims to collect data, information, opinions and suggestions from society on the criteria that should be established in the pricing of advanced therapy products.
Such information will support the preparation of the Regulatory Impact Analysis (“RIA”) before CMED creates rules on specific aspects related to the pricing criteria for advanced therapy products.
According to CMED, there is a significant time gap between the current legal framework for drug pricing, published over 20 years ago (Law 10.742/2003 and Resolution 02/2004), and the marketing authorization rule for advanced therapy products (RDC 505/2021), resulting in these products being categorized as omitted cases by CMED.
Therefore, CMED recognizes that establishing criteria for pricing advanced therapy products will promote greater transparency, public integrity, and legal certainty, resulting in regulatory alignment with best regulatory practices.
Contributions to the Notice of Call will be made through this link and may be submitted between February 10 th and March 28 th, 2025. The RIA results and report will be published on the CMED website.
Our Life Sciences & Healthcare team is available if you have any questions about this matter and its possible developments via email: lifesciences@soutocorrea.com.br.