QR Group analyzes the impacts of the proposal on the pharmaceutical sector and how companies can prepare for the new regulatory scenario

The Drug Market Regulation Chamber (CMED), linked to ANVISA, announced in July 2025 the start of a structured dialogue with the regulated sector to discuss the revision of drug pricing rules in Brazil. The initiative aims to modernize the criteria currently adopted, ensuring greater transparency, predictability and alignment with the reality of the market and innovation in health.

QR Group, a consultancy specializing in regulation and market access strategies, analyzes the potential impacts of the review and advises pharmaceutical companies on how to position themselves in the face of the proposed changes.

What is under discussion in the CMED proposal?

The process of reviewing the rules for pricing medicines was structured based on three pillars:

• Review of the current pricing methodology, both for new and similar and generic drugs;

• Adoption of criteria of therapeutic value and budgetary impact on price formation;

• Proposal to expand social participation and the regulated sector in the construction of the new guidelines.

CMED intends to open consultations and technical meetings with representatives of industry, associations, public agencies and academia, promoting a collaborative construction of future standards.

What are the impacts on the pharmaceutical industry?

The regulatory review of pricing can generate substantial changes in the models of entry and maintenance of products in the Brazilian market. The main points of attention for companies are:

• Changes in factory price and maximum consumer price (PMC) criteria;

• Possible adoption of pricing models based on clinical value, as is already the case in Europe;

• New requirements for pharmacoeconomic data and real world evidence for pricing;

• Direct impact on negotiations with SUS and private distribution channels.

Companies that anticipate discussions and prepare with robust technical arguments will have more security and influence in the decision-making process.

How QR Group supports companies in the pricing landscape

QR Group offers complete strategic support for companies looking to register medicines and define effective pricing and market access strategies:

• Preparation of dossiers of therapeutic value and pharmacoeconomic analyses;

• Technical support in pricing processes with CMED;

• Regulatory monitoring and guided participation in public consultations;

• Alignment of commercial strategies with current and future economic regulation.

Our focus is to turn regulation into a competitive advantage, with solutions that balance technical compliance and market viability.

Talk to QR Group

Does your company work with medicines and need to prepare for changes in pricing?
QR Group offers technical and strategic support to ensure regulatory security and market intelligence in all its launches.

Source: ANVISA