May 6, 2025
On May 5, the Brazilian Drug Market Regulation Chamber (CMED) has published the Call for Contributions Notice #1,330/2025 in the Federal Register, aiming to collect suggestions for the proposed revision of CMED’s Ordinance #2, of March 5, 2004. The current ordinance sets forth the criteria for pricing new products and new presentations of drugs, as well as the procedures for submitting the Price Information Document (DIP).
The draft resolution is available for public consultation at the following adress: Consulta Pública da Resolução CMED n.º 2/2004 — Agência Nacional de Vigilância Sanitária – Anvisa. It introduces significant changes to the price-setting process and key changes include:
The draft introduces a new categorization for new products and new presentations, explicitly encompassing incremental drug innovation, biosimilars, and drugs whose ownership was transferred to another company.
For Category 1, the only proposed change regarding the requirement of patented molecules is to clarify that molecules whose patent applications have been rejected by the Brazilian Patent and Trademark Office (BRPTO) or whose patents are no longer in force shall not be deemed patented. Additionally, the revised rule eliminates the current requirement of demonstrating a significant reduction in the overall cost of treatment for this category.
The proposal also introduces a new category (Category 3) for incremental drug innovation, while reclassifying as Category 4 the new presentations of products already marketed by the same company (currently covered under Category 3). The draft provides detailed criteria for incremental innovation (e.g., new combinations, new monodrug, new administration method, new pharmaceutical form, new packaging), expressly excluding merely aesthetic or commercial modifications.
Other changes include the creation of Categories 7 and 8, addressing non-new biological drugs or biosimilars, and drugs resulting from ownership transfer, respectively.
The concept of an “omissive case” (caso omisso) remains in the new draft, under the same terms as the current regulation.
The draft sets a 60-day deadline, counted from the date of the drug's marketing approval, for companies to submit the DIP for all registered drugs, regardless of the prioritization of the marketing approval process. The submission must be made through CMED's Executive Secretariat’s electronic system. Failure to meet this deadline will result in the initiation of an sua sponte process to determine the initial Factory Price (PF).
The new DIP must include more robust clinical, pharmacoeconomic, and scientific evidence, as well as documents proving innovative activities conducted in Brazil. The draft also introduces a simplified DIP for companies that already hold CMED-approved PFs and opt for a simplified regulatory process for marketing approval.
The proposal retains the rule that the requested PF cannot exceed the lowest PF in the reference countries (price basket). However, the draft expands the price basket to: Germany, Norway, Japan, Mexico, Australia, Canada, Spain, the United States, South Africa, France, Greece, Italy, Portugal, the United Kingdom, and the country of origin of the product. Currently, the basket includes: Australia, Canada, Spain, the United States, France, Greece, Italy, New Zealand, and Portugal.
The draft also proposes increasing the minimum number of countries for price comparison from three (as currently required) to five.
Products developed and manufactured in Brazil will be exempt from the requirement of being marketed internationally for the purpose of establishing a final PF.
Regarding provisional pricing, the draft also expands the scenarios in which CMED may define provisional prices, including:
The draft sets forth the procedures and deadlines for DIP analysis, currently governed by Communication #10, of August 10, 2016. The CMED Executive Secretariat must issue decisions:
These deadlines may be extended once, for an equal period.
Decisions issued by the Executive Secretariat may be appealed to CMED’s Technical-Executive Committee (CTE/CMED) within 30 days from notice or publication. The Secretariat may reconsider the decision within 90 days.
The deadline for submitting contributions to the public consultation is 60 days, starting on May 12, 2025. Suggestions must be submitted through ANVISA’s website or via the Participa + Brasil platform.
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