On May 5, 2025, the Drug Market Regulation Chamber (CMED) announced two initiatives aimed at revising the regulatory framework for drug prices in Brazil.

These initiatives include a public consultation to update CMED Resolution No. 2/2004 – the foundational regulation that defines the pricing criteria for new drugs and new presentations, and a call for proposals to gather input on the mandatory publication of drug prices in specialized media. Below are the main points.

Public Consultation No. 1,330/2025 to review CMED Resolution 2/2004

CMED Resolution 2/2004 began to be revised in 2019 through a Regulatory Impact Analysis (RIA) process carried out by the CMED’s Technical-Executive Committee in January 2019, considering the dysfunctionalities in the current economic regulation model of drugs, which hinders access to these products. The documents prepared within the RIA on the matter are available here.

Through Public Consultation No. 1,330/2025, CMED presented a proposal for a resolution that comprehensively revises the criteria for pricing new drugs and new presentations, as well as the procedure for submitting the Price Information Document (DIP). Among the main aspects brought by the proposed regulation are:

  • Updating the definitions and categories of new products and new presentations

 

  Current Wording Proposed Wording
New Products Drugs with a new molecule in the country. Drugs with a new active pharmaceutical ingredient (API) in the country.
New Presentations All drugs that do not fit the definition of New Products. All drugs that do not fit the definition of New Products.
  Current Wording Proposed Wording
Category 1

New Product with a molecule that is the object of a patent in the country and that brings gains in treatment in relation to drugs already used for the same therapeutic indication, with proof of one of the following requirements:

a) greater efficacy in relation to existing medicines for the same therapeutic indication;

b) the same efficacy with a significant reduction in adverse effects; or

c) the same efficacy with a significant reduction in the overall cost of treatment.

 New Product that, cumulatively: a) has a molecule that is the subject of a patent in the country; and b) presents a therapeutic gain in relation to the therapeutic alternative(s).
Category 2 New Products that do not meet the definition of Category 1.   New Product that does not concurrently meet the requirements of Category 1.
Category 3 New presentation of a drug already marketed by the company itself, in the same pharmaceutical form.

Drug with incremental innovation, according to the following types:

a) new combination;

b) new monodrug;

c) new route of administration;

d) new concentration;

e) new pharmaceutical form;

f) new packaging; or

g) different incremental innovation (i.e. change in relation to the originator drug as a result of innovative activity).
Category 4

New presentation of a drug that qualifies for one of the following situations:

a) a medicine that is new to the list of medicines marketed by the company, with the exception of Category 5 cases;

b) drug already marketed by the company, in a new pharmaceutical form.

 New presentation of a drug that is new to the list of those marketed by the company or a drug already marketed by the company, in a new non-groupable pharmaceutical form.
Category 5

Drugs that fall into one of the following situations:

a) new pharmaceutical form in the country;

b) a new combination of active ingredients that already exist in the country.

 New presentation of a drug already marketed by the company itself and by companies in the same economic group, in a groupable pharmaceutical form.
Category 6 Drug classified as generic. Drug classified as generic.
Category 7 N/A Drug classified as a non-new biological or biosimilar.
Category 8 N/A Drug resulting from transfer of ownership.

 

  Current Wording Proposed Wording
Reference Country Australia, Canada, Spain, United States of America, France, Greece, Italy, New Zealand, Portugal Germany, Norway, Japan, Mexico, Australia, Canada, Spain, United States of America, South Africa, France, Greece, Italy, Portugal, and the United Kingdom, in addition to the country of origin of the product, as applicable.

Definition of a 60-day deadline for Marketing Authorization holders of new products and new presentations to submit the price request to CMED, under penalty of price determination by the authority.

Inclusion of innovative activity as a criterion to be considered by CMED for setting factory price in specific situations. For context, innovative activity is defined as the activity representing the company's efforts towards the development and implementation of new products or significantly improved new presentations compared to those available in the Brazilian market.

Possibility of fixed price determination by CMED for drug presentations developed exclusively for specific population groups, regardless of concentration.

Creation of a simplified Price Information Document (DIP), defined as a dossier to be submitted by Marketing Authorization holders that already have a factory price defined by CMED and that choose to comply with simplified sanitary registration procedures;

Definition of provisional prices by CMED in certain situations, such as: when the molecule's patent application is under review by INPI or when the company has not submitted the Price Information Document (DIP) within 60 days after the Marketing Authorization publication.

Contributions can be sent until July 10.

Call for Proposals No. 2/2025 on the publication of prices in specialized media

Call for Proposals No. 2/2025 aims to gather input from industry stakeholders on the publication of drug prices in widely circulated specialized media to understand how this obligation, as outlined in Resolution No. 2/2018, is being implemented in practice.

With this initiative, CMED intends to map out any existing challenges or barriers and assess the perception of different agents regarding its usefulness and impact, including potential improvements and alternative proposals.

Contributions can be submitted until June 6.

Life Sciences & Health practice can provide more information on the topic.