Understand how CMED’s Directed Consultation impacts the advanced therapies market and how QR Group helps companies to adapt
The Drug Market Regulation Chamber (CMED) published Call Notice 01/2025 in the Federal Official Gazette on February 7, inviting health professionals, pharmaceutical industries and other interested parties to participate in the consultation on the pricing of advanced therapy products. QR Group, a specialist in health product regulation, highlights the importance of this initiative for the definition of clearer and more accessible criteria in the sector.
Impacts of CMED’s Targeted Consultation on the Advanced Therapies Market
The pricing of advanced therapies represents a significant challenge for the pharmaceutical industry, directly affecting the economic viability and the population’s access to innovative treatments. The targeted consultation aims to collect data and opinions to improve the regulation of this market, ensuring a more transparent and innovation-friendly environment.
Contributions can be sent from February 10 to March 28, through the form available on the ANVISA website. The active participation of society is essential for the standards to reflect the reality of the sector and promote a balance between innovation and financial sustainability of health systems.
How QR Group Ensures Compliance and Process Agility
QR Group has expertise in the regulation of health products with ANVISA and understands the challenges faced by manufacturers of advanced therapies. With a highly qualified team, the company assists in adapting to regulatory criteria, ensuring that its customers are in compliance with the requirements of the Brazilian market.
In addition, QR Group offers strategic support in product pricing, helping manufacturers navigate the complexities of the market and ensure the viability of their treatments.
Participate and Contribute to the Regulation of the Sector
If you are a manufacturer of advanced therapies and want to understand how targeted consultation can impact your business, contact QR Group. Our team is ready to provide expert guidance and ensure that your business is prepared for the new regulatory guidelines.
Access ANVISA’s consultation and contribute to the construction of a more efficient regulatory environment for advanced therapies.
Source: ANVISA