Newsletters

Life Sciences and Healthcare Newsletter | December 2025

January 22nd, 2026

The Life Sciences and Healthcare Bulletin offers monthly updated information on the main topics, laws and standards related to the life sciences and health sector in Brazil and is an opportunity to access legal information and comments on relevant market issues.

Enjoy reading!

Demarest’s Life Sciences and Healthcare Team

This material is for informative purposes only, and should not be used for decision-making. Specific legal advice can be provided by one of our lawyers.

ANVISA publishes new regulatory framework for herbal medicines

On December 17, 2025, the Brazilian Health Regulatory Agency (“Anvisa”) published four new regulations providing for herbal medicines:

Resolution No. 1,004/2025: Defines the categories of herbal medicines and traditional herbal medicines and establishes the minimum requirements for the marketing authorization and notification of these products.
Normative Instruction No. 410/2025: Provides for prohibitions and restrictions applicable to the composition of herbal medicines.
Normative Instruction No. 411/2025: Provides for the control of pesticide residues and similar substances in herbal medicines.
Normative Instruction No. 412/2025: Provides for the Brazilian list of plant species eligible for the simplified marketing authorization procedure of herbal medicines.

According to Anvisa, the creation of a new regulatory framework for herbal medicines aims to:

Update standards that had not been thoroughly reviewed for more than 10 years;
Align Brazilian rules with international standards – particularly the European Medicines Agency (EMA); and
Increase the potential for utilizing Brazilian biodiversity by consolidating regulatory procedures and considering different levels of knowledge regarding therapeutic plants.

Previously, the marketing authorization and notification of herbal medicines and traditional herbal products were regulated by Collegiate Board Resolution (“RDC”) No. 26/2014 and Normative Instruction (“IN”) No. 4/2014.

The new regulatory framework repeals these rules and:

Updates and further details technical and conceptual definitions;
Standardizes registration and notification requirements;
Modernizes quality control by recognizing different types of extracts and expanding the scope of acceptable quality assurance methods;
Allows for varying levels of evidence to demonstrate safety and efficacy;
Introduces a risk‑management regime; and
integrate post-‑marketing authorization, renewal, and labeling procedures into the general framework for medicines, ensuring alignment with national and international monographs.

We have summarized the key elements of the new framework next:

Herbal medicine classification

Resolution No. 1,004/2025 updates the classification of herbal medicines into herbal medicines and traditional herbal medicines.

Herbal medicines are made exclusively from active plant raw materials, exhibit consistent quality, and have safety and efficacy supported by clinical evidence.

Traditional herbal medicines are also exclusively made from these raw materials and exhibit consistent quality; however, their safety and effectiveness are supported by technical‑scientific data. This class of herbal medicines can be used by humans without a diagnosis, prescription, or medical supervision, provided they are not used to treat serious diseases, disorders, or health conditions.

These medicines cannot contain raw materials in concentrations that pose a known toxic risk, nor can they be administered via injection or ophthalmic routes.

ANVISA: Marketing authorization and notification applications

Obtaining the marketing authorization for herbal medicines requires manufacturers and importers to file an application for each pharmaceutical form. They must submit the documentation listed in RDC No. 948/2024 and prove compliance with the requirements listed in Resolution No. 1,004/2025, in line with the product specifications.

For traditional herbal medicines that require notification for sale, all documentation listed in RDC No. 948/2024 and Resolution No. 1,004/2025 must be prepared and kept at the company. The only information that must be sent to ANVISA is that listed in Resolution No. 1,104/2025 regarding the type of product to be notified.

Only manufacturers holding a Good Manufacturing Practices Certificate (CBPF) for medicinal products, or importers holding a Good Distribution and Storage Practices Certificate (CBPDA), and that are duly authorized or licensed by Anvisa, may submit notifications for herbal medicines provided for by Resolution No. 1,004/2025.

Plant-Based Active Pharmaceutical Ingredients (Plant-Based APIs): Best practices and liability

The manufacturing of herbal medicines must comply with Good Agricultural and Collection Practices (GACP), Good Processing and Storage Practices, and Good Manufacturing Practices applicable to both active ingredients and finished medicines.

In addition, marketing authorization or notification applicants are liable for the quality of the API used to manufacture herbal medicines. Applicants must submit (marketing authorization) or keep available at the company (notification) a statement signed by the technical manager at the medicine manufacturer, or a person designated by them, ensuring the quality of the API used in the medicines.

Labeling

Herbal medicines must be accompanied by a package insert and by primary and secondary packaging, which must be manufactured in line with the criteria defined in RDC No. 47/2009 (which provides for the drafting, standardization, update, publication, and availability of package inserts for patients and healthcare professionals) and RDC No. 768/2022 (which establishes rules for labeling medicines), respectively.

In addition, the APIs used in these products must be listed on their package inserts and labels, in compliance with the Anvisa guidelines for the Marketing authorization and Notification of Herbal Medicines. ANVISA approved the draft for the guide at a collegiate board meeting held on December 17, 2025, and publication is scheduled for early 2026.

Transitional regime and entry into force

Marketing authorization or post-marketing authorization applications filed prior to the publication of Resolution No. 1,004/2025 will be reviewed according to the regulation in force at the time of filing.

Among these applications, those whose analysis has not yet begun may be evaluated under the terms of the new resolution, provided they meet its requirements. To this end, the applicant must amend the application to request this process prior to the start of the review.

For herbal medicines whose development began during the term of RDC No. 26/2014 and IN No. 4/2014, but have yet to be granted marketing authorization, Anvisa will accept the submission of studies conducted in line with the regulation in force prior to the publication of Resolution No. 1,004/2025, provided they apply for marketing authorization within three years of the repeal of these rules.

Herbal medicines already provided for by RDC No. 26/2014 will remain valid and need not comply with the new concepts. They will only be subject to updates to labeling, package inserts, and informational leaflets for the package insert.

Resolution No. 1,004/2025 and the three normative instructions that comprise the regulatory framework for herbal medicines will come into force on February 20, 2026 (60 days after the publication of the rules in the Federal Official Gazette on December 22, 2025).

Manufacturers or importers that do not meet the criteria of the new resolution may incur a health violation. They will be subject to administrative sanctions established by Law No. 6,437/1977, without prejudice to other applicable civil, administrative, and criminal sanctions.

For more information, see Resolution No. 1,004/2025 in full.

Brazilian Drug Market Regulation Chamber (“CMED”) updates medicine pricing rules

CM/CMED Resolution No. 3/2025, published on December 19, 2025, marks a step forward in the economic regulation of the pharmaceutical sector by establishing new rules for setting launch prices and categorizing medicines.

In addition, the resolution details essential concepts such as “therapeutic alternative,” “innovative activity,” “therapeutic gain,” and “incremental innovation,” which are now decisive factors in establishing the maximum price allowed for medicines in the Brazilian market.

See below the key elements of the new resolution.

Classification of medicines

The resolution establishes criteria for classifying medicines into specific categories, which will serve as the basis for setting the regulated price.

Products considered new, that is, those containing an API that is new to Brazil are classified into two categories:

Category 1 applies to products that demonstrate a proven therapeutic gain compared to existing alternatives.
Category 2 applies to products that do not demonstrate any additional clinical benefit.

For new presentations, the resolution introduces six additional categories:

Category 3 covers products with incremental innovation, such as new combinations, single-agent medicines, routes of administration, concentrations, pharmaceutical forms, packaging, or other relevant technological improvements.
Categories 4 and 5 include new presentations without significant innovation, differing in the degree of grouping with existing pharmaceutical forms.
Category 6 is for generic medicines, while Category 7 encompasses biological products that do not qualify as new products or incremental innovations.

The regulation also provides for exceptional situations, including the possibility of disregarding pharmaceutical‑form grouping when scientific evidence justifies differentiation. In addition, the resolution establishes that products classified by Anvisa as innovative will be placed in Category 3, provided they meet the definition of incremental innovation. Cases not covered by the established categories will be treated as omissions and subject to technical review by CMED.

Criteria for pricing advanced‑therapy products and radiopharmaceuticals will be regulated in specific acts. Thus, for the purposes of implementing CM/CMED Resolution No. 3/2025, products within these categories will be treated as omitted cases until the respective normative acts are published.

Documents required to establish the ex-factory price

Under the new rules, marketing authorization applicants must submit a price-setting request to CMED, accompanied by a Medicine Pricing Information Dossier (DIP) – a compilation of administrative and technical documents – for setting the ex-factory price in the Brazilian market. The dossier must be submitted after the application has been filed but before its approval is published in the Federal Official Gazette of Brazil. In addition, applicants must monitor the authorization process with Anvisa.

The dossier should include a main document signed by the company’s legal representative, containing the rationale for the application and the information required for the medicine’s category. Studies and expert reports related to the product must be submitted as annexes to the dossier. They may be amended with additional information at any time prior to the publication of the authorization.

Upon the entry into force of the new regulation and upon notification to the interested companies, CMED may, on its own initiative, initiate a procedure to establish the ex-factory price of authorized products that either do not have an established price or whose dossier was not submitted prior to publication of their authorization.

Ex-factory price-setting criteria

The resolution establishes parameters for determining the ex‑factory price. As a general rule, the company’s proposed price for the medicine may not exceed the lowest price charged in the benchmark countries for the same product, plus applicable taxes.

The following countries are considered benchmarks: Australia, Canada, France, Germany, Greece, Italy, Japan, Mexico, Norway, Portugal, South Africa, Spain, the United Kingdom, and the United States of America – in addition to the product’s country of origin, as applicable.

If the product is not yet marketed in at least four of the benchmark countries, CMED will establish a provisional price. In turn, the applicant company must submit documents to CMED’s Executive Secretariat every year proving that the product has been launched in these countries, with its respective price, until this criterion is met, under penalty of sanctions and fines.

If the company does not sell the product in other countries, the benchmark will be the price of products with the same API and the same groupable pharmaceutical form in the benchmark countries

When pricing considers therapeutic alternatives, the cost of treatment is calculated based on technical criteria, such as indication, line of therapy, route of administration, and dosage, to ensure comparability between options.

The regulation also allows flat pricing for presentations with different strengths when it is demonstrated that they yield the same therapeutic effect or when international prices are uniform.

There are also specific criteria for each category. Products classified in Category 1 (new IFA with therapeutic gain) will be capped at the lowest international price, and the company’s price rationale may be adopted when there is no benchmark or when development occurs in Brazil.

For Category 2 (new API without therapeutic gain), pricing will be limited to the comparator’s treatment cost. It may not exceed the lowest price practiced in the benchmark countries. Medicines with incremental innovation (Category 3) may have a differentiated price if they demonstrate additional benefits, such as greater safety or efficiency for the healthcare system, supported by robust scientific evidence.

The other categories have specific rules:

Categories 4 and 5 (new presentations without significant innovation) will be priced based on weighted or arithmetic averages.
Category 6 (generics) may not exceed 65% of the reference product price.
Category 7 (non‑innovative biological products) must be priced at a 20% discount relative to the originator, with the possibility of a unified price.
Category 8 (changes in marketing authorization holder) must follow limits tied to the historical prices of the previous holder.

Review and decision-making

CM/CMED Resolution No. 3/2025 establishes a detailed workflow for reviewing price-setting requests, ensuring greater predictability and transparency in the process. The decision on the claim’s compliance will be based on a technical opinion. In this case, the company may request a hearing to present and support the scientific evidence compiled in the dossier. For claims of additional clinical benefit, CMED may consider documents already submitted to ANVISA in the authorization process.

The deadlines for the decision vary according to the medicine’s category: up to 60 days for new presentations (Categories 4 to 8) and up to 90 days for new products (Categories 1 to 3) or omitted cases, counted from the publication of the registration.

These deadlines may be extended once for an equal period and will be suspended when there are requests for clarification or supplemental documentation. If CMED does not issue a decision within the deadline, the medicine can be sold at the requested price until the final decision is issued.

The resolution provides for the fast-track proceedings of requests filed by the Ministry of Health, with deadlines reduced by half. The regulation also provides for the right to appeal: Decisions issued by the Executive Secretariat may be challenged before the Technical‑Executive Committee within 30 days, with the possibility of reconsideration at the first level. Specific decisions, such as those involving omitted cases or special pricing criteria, are subject to a mandatory second review, even in the absence of an appeal by the company.

Transition rules

CM/CMED Resolution No. 3/2025 will enter into force 120 days after its publication, that is, on April 29, 2026. In addition to new cases occurring after it enters into force, the resolution also applies to:

Dossier analysis proceedings pending a ruling in the first instance with the CMED Executive Secretariat;
Products classified as omitted cases, which are pending before the Technical-Executive Committee in the first instance; and
Products that have provisional prices established under CMED Resolution No. 2 of March 5, 2004, which have not yet become final.

Companies requesting price approval for medicines that fall within the scenarios described above must submit the supplemental documentation required under the resolution within 30 days from its entry into force. If the supplemental documentation is not submitted within the established deadline, CMED’s Executive Secretariat will notify the applicant company to comply with the requirement. Otherwise, CMED may initiate a proceeding on its own initiative to determine the product’s initial ex‑factory price.

For more information, see CM/CMED Resolution No. 3/2025 in full.

BRAZILIAN HEALTH REGULATORY AGENCY (“ANVISA”)

RDC No. 1,000/25: Establishes the control requirements for prescription notifications, controlled substances prescriptions, and prescriptions subject to retention issued in electronic format.

RDC No. 1,001/25: Provides for the classification, under the fast-track proceeding, of claims for marketing authorization, post-marketing authorization, prior consent for clinical trials, and Certification of Good Manufacturing Practices for medicines and active pharmaceutical ingredients.

RDC No. 1,002/25: Provides for the Good Operating Practices requirements for services that provide dental care.

RDC No. 1,003/25: Amends ANVISA Collegiate Board Resolution No. 976, dated June 05, 2025, which provides for the health requirements for infant formulas, nutrient formulas for high‑risk newborns, transitional foods and cereal‑based foods for infants and young children, enteral nutrition formulas, and dietary formulas for inborn errors of metabolism.

RDC No. 1,004/25: Provides for the marketing authorization of herbal medicines and the marketing authorization and notification of traditional herbal medicines.

RDC No. 1,005/25: Provides for the streamlined review of applications for the evaluation and toxicological classification of formulated products obtained from technical products that are not equivalent to active ingredients already registered, among other provisions.

RDC No. 1,006/25: Establishes additional requirements for streamlining the analysis of technical product applications by equivalence, with regard to toxicological profiles.

RDC No. 1,007/25: Defines the officers responsible for the Brazilian Health Regulatory Agency boards.

RDC No. 1,008/25: Amends Collegiate Board Resolution – RDC No. 73, dated April 7, 2016, which provides for post-marketing authorization changes and cancellation related to medicines with synthetic and semisynthetic active ingredients; and Collegiate Board Resolution – RDC No. 47, dated September 8, 2009, which establishes rules for the drafting, standardization, update, publication, and availability of medicine package inserts for patients and healthcare professionals.

RDC No. 1,009/25: amends Collegiate Board Resolution – RDC No. 585, dated December 10, 2021, which approves and enacts the Internal Regulations of the Brazilian Health Regulatory Agency – Anvisa.

IN No. 410/25:: Provides for prohibitions and restrictions applicable to the composition of herbal medicines.

IN No. 411/25:: Provides for the control of pesticide residues and similar substances in herbal medicines.

IN No. 412/25:: Provides for the Brazilian list of plant species eligible for the simplified marketing authorization procedure of herbal medicines.

IN No. 413/25: Publicizes the updated Reference Listed Drugs (“LMR”) in Brazil.

IN No. 414/25: Amends Normative Instruction – IN No. 367, dated June 05, 2025, which establishes lists of ingredients, limits of use, and authorized claims for infant formulas, specialized formulas for high-risk newborns, transitional foods and cereal-based foods for infants and children in early childhood, enteral nutrition formulas, and dietary supplements to address inborn errors of metabolism.

IN No. 415/25: Updates IN No. 211, dated March 01, 2023, which establishes the technological functions, limits and conditions of use for authorized food additives and processing co-formulants.

IN No. 416/25: Provides for the update of the list of Brazilian Common Denominations (DCB).

IN No. 417/25:: Amends the monograph of active ingredient T84 – THYMUS VULGARIS in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 418/25: Updates Normative Instruction No. 28, dated July 26, 2018, which establishes the lists of ingredients, limits of use, alleged benefits, and supplementary labeling of food supplements.

IN No. 419/25: Amends Normative Instruction – IN No. 159, dated July 1, 2022, which establishes the lists of plant parts authorized for preparing teas and for use as spices.

IN No. 420/25:: Amends the monograph of active ingredient T84 – THYMUS VULGARIS in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 421/25:: Provides for the inclusion of the monograph of active ingredients in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

BRAZILIAN FEDERAL MEDICINE COUNCIL (“CFM”):

CFM Resolution No. 2449/25: Provides for the annulment of item VII of Article 4 and Article 11 of Annex I of CREMERS Resolution No. 02/2018, which stipulates that healthcare establishments and other legal entities where medicine is practiced in the state of Rio Grande do Sul must structure their respective clinical bodies in accordance with the standard model detailed in Annex I.

CFM Resolution No. 2450/25: Budget forecast of the Federal Council of Medicine and Regional Councils of Medicine for the 2026 fiscal year.

CFM Resolution No. 2451/25: Extends the administrative intervention period in the Regional Medical Council of the State of Rio de Janeiro (CREMERJ); mandates the holding of internal elections for board positions; defines the exceptional nature of terms of office; and updates the frequency of monitoring.

FEDERAL PHARMACY COUNCIL (“CFF”):

CFF Resolution No. 21/25: Updates Article 53 of Resolution No. 8, dated June 25, 2024, which approves the Standard Internal Regulations of the Regional Pharmacy Councils.

CFF Resolution No. 22/25: Updates Article 78 of Resolution/CFF No. 483/08, repealing Articles 32, 34, 36, and 38 of Resolution/CFF No. 483/08 and subsequent amendments.

FEDERAL COUNCIL OF BIOMEDICINE (“CFBM”):

CFBM Resolution No. 410/25: Provides for the regulation of Federal Law No. 14,133, dated April 1, 2021, which provides for Bids and Administrative Contracts, within the scope of the Federal Council of Biomedicine.

CFBM Resolution No. 412/25: Regulates access to information and citizen services within the scope of the Federal Council of Biomedicine and the Regional Councils of Biomedicine.

CP ANVISA No. 1360/25: Proposed normative instruction updating 21 monographs in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published through Normative Instruction – IN No. 103, dated October 19, 2021 – B41 – BOSCALID, B55 – EMAMECTIN BENZOATE, C58 – ALPHA-CYPERMETHRIN, C63 – LAMBDA-CYHALOTHRIN, D41 – DIAFENTHIURON, D55 – DINOTEFURAN, D59 – DIMPROPYRIDAZ, E29 – ETHIPROLE, I13 – IMIDACLOPRID, L05 – LUFENURON, M02 – MANCOZEB, M40 – MESOTRIONE, P13 – PROFENOFOS, P21 – PROPICONAZOLE, P34 – PYRIPROXYFEM, P49 – PYRAFLUFEN, P50 – PICOXYSTROBIN, P53 – PROTHIOCONAZOLE, Q05.1 – QUIZALOFOP-P ETHYL, T32 – TEBUCONAZOLE and T48 – THIAMETHOXAM.

Contribution deadline: February 07, 2026

CP ANVISA No. 1361/25: Proposed regulatory act that will address the guidelines and criteria for the application of oversight within the scope of the Brazilian Health Regulatory Agency.

Contribution deadline: February 23, 2026

CP ANVISA No. 1362/25: Proposed regulatory act regarding the draft RDC that provides for the requirements of good practices, the principles of the Hazard Analysis and Critical Control Points (HACCP) System, and Standard Operating Procedures (SOP) to be implemented in the food production chain.