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Life Sciences and Healthcare Newsletter | December 2024

January 22nd, 2025

The Life Sciences and Healthcare Newsletter brings information and news on the key issues and recent legislation related to the life sciences and healthcare sector in Brazil. This initiative encompasses transactional and regulatory industry matters and invites all market players to access relevant news of the sector and our comments on such topics.

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.

 

MAIN NEWS

ANS publishes resolution on regulatory sandbox

On December 16, 2024, the Brazilian Supplementary Healthcare Agency (ANS) published Normative Resolution No. 621/24, which sets the rules for establishing and operating the ANS regulatory sandbox. 

The initiative aims to foster the development of new solutions, reduce costs and maturation time, improve the current regulatory framework, and stimulate competition within the sector.

The resolution entered into force on its publication date and enables companies to test new services, products, or technologies in an experimental regulatory environment, with temporary authorizations, promoting innovation and the adaptation of innovative solutions for the market.

Find out more: ANS publishes resolution on experimental regulatory environment – the Regulatory Sandbox – Demarest  

 

ANVISA publishes resolution on simplified procedure for medicine registration, post-registration, and registration renewal

On December 23, 2024, the Brazilian Health Regulatory Agency (ANVISA) published Collegiate Board Resolution (“RDC”) No. 954/24, which establishes criteria applied to the simplified procedure for the registration, post-registration, and registration renewal of generic, similar, specific, dynamized, herbal, radiopharmaceutical and biological products. 

Note: On January 20, 2025, Anvisa published RDC No. 960/25, which postpones the entry into force of RDC No. 954/24 to March 25, 2025. In turn, the possibility of Anvisa requesting a complete or partial dossier will come into force on June 22, 2025.

Find out more: UPDATE: ANVISA publishes resolution for marketing authorization applications, post-approval changes, and simplified renewal procedures – Demarest

 

ANVISA updates clinical research regulatory framework

On December 02, 2024, ANVISA published two regulations to update the regulatory framework for clinical research in Brazil:

  • RDC No. 945/24: Establishes rules for conducting clinical trials with the goal of subsequently registering medicines.
  • Normative Instruction (“IN”) No. 338/24: Establishes the list of Equivalent Foreign Regulatory Authorities (AREE), detailing the criteria for adopting an optimized analysis procedure (regulatory reliance).

The updates of the new regulatory framework aim at reducing red tape and simplifying the clinical development of medicines without compromising the technical requirements necessary to verify their safety and effectiveness.

The new regulation entered into force on January 01, 2024.

Find out more: ANVISA approves new regulatory framework for clinical research in Brazil — ANVISA (www.gov.br) (Portuguese only)

 

PUBLISHED NORMATIVE ACTS

 

BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA):

RDC No. 945/24: Establishes guidelines and procedures for conducting clinical trials in Brazil with the goal of subsequently registering medicines.

RDC No. 946/24: Changes RDC No. 585 of December 10, 2021, which approves and enacts ANVISA’s internal regulations.

RDC No. 947/24: Establishes procedures for filing documents within the scope of ANVISA.

RDC No. 948/24: Establishes health requirements for the good standing of medicinal products for human use.

RDC No. 949/24: Changes RDC No. 907 of September 19, 2024, and internalizes GMC MERCOSUR Resolution No. 18/2023.

RDC No. 950/24 Establishes complementary requirements for the optimized analysis of requests for evaluation and toxicological classification of formulated products obtained from equivalent technical products, in addition to other provisions.

RDC No. 951/24: Establishes procedures for migrating the procedure to legitimize personal hygiene products, cosmetics, perfumes, and disposables exempt from registration from the SGAS Cosmetics Automated System into the “Solicita/Datavisa” system.

RDC No. 952/24: Approves Errata No. 2 of the Brazilian Pharmacopoeia Phytotherapy Form, 2nd edition, for which RDC No. 463, of January 27, 2021, provides.

RDC No. 953/24: Defines the officers in charge of ANVISA’s boards.

RDC No. 954/24: Provides for the simplified medicine registration, post-registration, and registration renewal procedure, in addition to other provisions.

RDC No. 955/24: Sets rules for establishing Brazilian Common Denominations (DCB) and the list of approved DCBs.

RDC No. 956/24: Changes RDC No. 873 of May 27, 2024, which establishes criteria and procedures for implementing computerized management to distribute the numbering of prescriptions and prescription pads in Brazil through the National Prescription Control System (SNCR), among other provisions.

RDC No. 957/24: Provides for the criteria to classify a medicine as a “reference listed drug” and the procedures for including and excluding medicines from the Reference Listed Drugs.

IN No. 336/24: Changes IN No. 28 of July 26, 2018, which establishes the lists of ingredients, limits of use, alleged benefits, and supplementary labeling of food supplements.

IN No. 337/24: Changes IN No. 258 of October 16, 2023, which provides for the list of qualified impurities and their respective limits

IN No. 338/24: In compliance with ANVISA RDC No. 945 of November 2024, establishes the list of equivalent foreign regulatory authorities (AREE) and details the criteria for adopting the optimized analysis procedure via reliance and risk and complexity assessment of requests for Drug Clinical Development Dossier (DDCM), Specific Clinical Trial Dossier (DEEC), substantial changes to the product under investigation and significant amendments to the clinical protocol.

IN No. 339/24: Provides for the inclusion of the monograph for active ingredient Q06 – CHITOSAN in the List of Active Ingredients for Pesticides, Disinfesting Sanitizers, and Wood Preservers, published through IN No. 103 19, of October 2021,.

IN No. 340/24: Provides for the inclusion of the monographs for active ingredients C90 – COFFEA SP and C91 – CORYMBIA CITRIODORA in the List of Active Ingredients for Pesticides, Disinfesting Sanitizers, and Wood Preservers, published through IN No. 103 of October 19, 2021.

IN No. 341/24: Provides for the change of monographs for active ingredients in the List of Active Ingredients for Pesticides, Disinfesting Sanitizers, and Wood Preservers, published through IN No. 103 of October 19, 2021.

IN No. 342/24: Approves the List of Brazilian Common Denominations (DCB) of the Brazilian Pharmacopoeia.

 

BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY:

RN No. 621/24: Sets out the rules for establishing and operating the experimental regulatory environment (regulatory sandbox) within ANS.

RN No. 622/24: Changes Normative Resolution No. 482, of March 16, 2022, which provides for the Internal Regulations of the Supplementary Health Chamber (“CAMSS”) to provide for the representation of segments of the pharmaceutical industry, the medical device and equipment industry and the diagnostic medicine industry in the composition of the CAMSS.

RN No. 623/24: Provides for the rules to be observed by private healthcare plan operators and benefits administrators regarding requests filed by beneficiaries for healthcare and non-healthcare coverage of services and procedures in any type of contract.

RN No. 624/24: Changes Normative Resolution (“RN”) No. 465, of February 24, 2021, which provides for the ANS’ list of mandatory health events and procedures in order to regulate the mandatory coverage of the immunobiological medicine secukinumab for treating adult patients with moderate to severe active hidradenitis suppurativa; oral antineoplastic medicine zanubrutinib for the first-line treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, and for treating adult patients with chronic lymphocytic leukemia or relapsed and refractory small lymphocytic lymphoma; and the immunobiological medicine nirsevimab for immune prophylactic therapy against respiratory syncytial virus, in compliance with the provisions of paragraphs 4, 7 and 8 of article 10 of Law No. 9,656/1998.

RN No. 625/24: Changes RN No. 465, of February 24, 2021, which provides for ANS’ list of mandatory health events and procedures, to update the mandatory coverage of the OUTPATIENT IV THERAPY (WITH UTILIZATION GUIDELINES) procedure, to establish the mandatory coverage of ferric derisomaltose for treating adult patients with iron deficiency anemia, after therapeutic failure, intolerance or contraindication to oral iron salts; and to establish mandatory coverage of the procedure HLA-B27 PHENOTYPING/GENOTYPING (WITH UTILIZATION GUIDELINES) in the diagnostic testing of axial spondyloarthritis, in compliance with the provisions of paragraphs 4 and 10 of article 10 of Law No. 9,656/1998.

 

MINISTRY OF HEALTH (“MS”):

GM/MS Ordinance No. 5803/24: Changes GM/MS Consolidation Ordinance No. 5, of September 28, 2017, to establish the National Program of Support to the Continuance, Diversity and Visibility for Students in the Healthcare Area (AFIRMASUS).

GM/MS Ordinance No. 5799/24: Changes GM/MS Consolidation Ordinance No. 5, of September 28, 2017, to provide for the National Program for Malaria Prevention, Control and Elimination (PNCEM).

GM/MS Ordinance No. 5764/24: Changes GM/MS Ordinance No. 4,160, of June 7, 2024, which establishes federal financial incentives for investment aimed at structuring telehealth points within the scope of the Digital SUS Program and the health axis of the Growth Acceleration Program (New PAC).

GM/MS Ordinance No. 5758/24: Changes GM/MS Ordinance No. 3,492, of April 8, 2024, which establishes the National Program for Expansion and Qualification of Specialized Outpatient Care, within the framework of the Brazilian Unified Healthcare System (“SUS”).

GM/MS Ordinance No. 5832/24: Changes GM/MS Consolidation Ordinance No. 1, of September 28, 2017, to provide for the Commission of Biosafety in Health.

GM/MS Ordinance No. 5820/24: Changes GM/MS Ordinance No. 90, of February 3, 2023, and repeals GM/MS Ordinance No. 1,370, of September 28, 2023.

GM/MS Ordinance No. 5713/24: Changes GM/MS Consolidation Ordinance No. 1, of September 28, 2017, to modify the information models to be adopted by the federative entities and the systems that integrate the SUS’ National Pharmaceutical Actions and Services Database (BNAFAR/SUS).

GM/MS Ordinance No. 5738/24: Changes MS Consolidation Ordinances No. 3 and No. 6 of September 28, 2017, to provide for the Social Center (CECO) of the Psychosocial Care Network (RAPS) within the scope of the SUS.

GM/MS Ordinance No. 6093/24: Establishes the Brazilian National Ontology of Medicines (OBM).

GM/MS Ordinance No. 6098/24: Changes MS Consolidation Ordinance No. 5, of September 28, 2017, to establish the National Program of SUS Experiences.

GM/MS Ordinance No. 6212/24: Establishes procedural rules for interfederative reimbursement regarding expenses resulting from court orders concerning medicine supply.

GM/MS Ordinance No. 6213/24: Changes GM/MS Consolidation Ordinance No. 3, of September 28, 2017, to include the Oral Healthcare Network (RASB) in the SUS National Oral Healthcare Policy (PNSB).

GM/MS Ordinance No. 6321/24: Changes Annex V of GM/MS Consolidation Ordinance No. 2, of September 28, 2017, to establish the National Committee for Popular Education in Health (CNEPS).

GM/MS Ordinance No. 6324/24: Establishes the SUS National List of Essential Medicines (RENAME) 2024 by updating the RENAME 2022 list of medicines and inputs.

GM/MS Ordinance No. 6325/24: Approves the Strategic Planning of the SUS National Audit Department for the 2024-2027 term.

GM/MS Ordinance No. 6326/24: Changes Annex XXVIII of Consolidation Ordinance GM/MS No. 2 of September 28, 2017, to provide for the enforcement of the SUS Specialized Component of Pharmaceutical Care.

CNS Resolution No. 763/24: Provides for the members and operation of the Technical Chamber of Digital Health and Health Communication, in addition to its members’ responsibilities.

 

BRAZILIAN FEDERAL NURSING COUNCIL (“COFEN”)

COFEN Resolution No. 771/24: Temporarily extends (“ad referendum” of the COFEN full court) 60 days the deadline for entry into force of COFEN Resolutions No. 769/2024 (updates administrative regulations for services relating to the registration of professionals) and No. 770/2024 (updates regulations and standards for producing, issuing, using and controlling professional identity documents, registration certificates for nursing companies, clinics or practices, and digital certificates).

 

BRAZILIAN FEDERAL PHARMACY COUNCIL (“CFF”)

CFF Resolution No. 18/24: Provides for the pharmacist’s attributions within the scope of sports pharmacy.

 

SOCIAL PARTICIPATION

Ética na saúde: resolução do CFM define que médicos informem vínculos com empresas de saúde

ANVISA Public Consultation No.1293/24 Revision proposal for IN No. 02/14, which published the “List of herbal medicines for simplified registration” and the “List of traditional herbal products for simplified registration.”
Contribution deadline: March 11, 2025

ANVISA Public Consultation No. 1294/24:RDC proposal that provides for the priority framing of requests for registration, post-registration, and prior approval in medicine clinical trials.
Contribution deadline: February 10, 2025

ANVISA Public Consultation No. 1295/24: IN proposal that includes the active ingredient C92 – CHROMOBACTERIUM SUBTSUGAE in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservers, published through IN No. 103 of October 19, 2021.
Contribution deadline: February 03, 2025

ANVISA Public Consultation No. 1296/24: IN proposal that includes the active ingredient B70 – ERINNYIS ELLO BACULOVIRUS in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preserves, through IN No. 103 of October 19, 2021.
Contribution deadline: February 03, 2025

ANVISA Public Consultation No. 1297/24 RDC proposal that provides for guidelines to be observed in health administrative sanctioning procedures (PAS) within the scope of ANVISA, among other provisions.
Contribution deadline: February 03, 2025

ANVISA Public Consultation No. 1298/24:: Proposal for changing monographs in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers, and Wood Preservers, published through IN No. 103 of October 19, 2021.
Contribution deadline: February 09, 2025

ANVISA Public Consultation No. 1299/24 Normative instruction proposal that changes IN No. 211 of March 01, 2024, which provides for the technological functions, limits, and conditions of use for authorized food additives and processing co-formulants.
Contribution deadline: February 17, 2025

ANVISA Public Consultation No. 1300/24: Normative instruction proposal that changes IN No. 211 of March 01, 2024, which provides for the technological functions, limits, and conditions of use for authorized food additives and processing co-formulants.
Contribution deadline: February 03, 2025

ANVISA Public Consultation No. 1301/24: Proposal of good working practices for dental care services.
Contribution deadline: March 24, 2025

ANVISA Public Consultation No. 1302/24: Proposal for changing 11 monographs in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservers, published through IN No. 103 of October 19, 2021: B33 – Bispyribac, B54 – Bixafen, B68 – Bixlozone, C40 – Chlorfenapyr, F72 – Fluopyram, O19 – Orthosulfamuron, P39 – Pyrithiobac, S19 – Sulfoxaflor, T61 – Tembotrione, T70 – Tolfenpyrad, T71 – Thiencarbazone-methyl.
Contribution deadline: February 17, 2025

ANVISA Public Consultation No. 1303/24: RDC proposal that provides for companies’ health risk management and compliance monitoring regarding the granting or renewing of the Certificate of Good Manufacturing Practices and the Certificate of Good Distribution and/or Storage Practices for Active Pharmaceutical Inputs (APIs), medicines, cannabis products for medicinal purposes, biological products and medical devices within the scope of ANVISA.
Contribution deadline: March 03, 2025

ANVISA Public Consultation No. 1304/24: Public consultation proposal addressing the update of the list of substances that cannot be used in personal hygiene products, cosmetics, and perfumes (negative list).
Contribution deadline: March 07, 2025

ANVISA Public Consultation No. 1305/24: Public consultation proposal addressing the update of the list of substances that personal hygiene products, cosmetics, and perfumes must not contain except under specific conditions and restrictions (restrictive list).
Contribution deadline: March 07, 2025

ANVISA Directed Consultation No. 4/24 Public call notice draft for selecting interested participants for the pilot project of the Regulatory Sandbox for personal hygiene products and personalized cosmetics.
Contribution deadline: January 31, 2025

ANVISA Public Call Notice No. 13/24 Request for technical information complementary to those already collected by ANVISA through contracted researchers and with review by the herbal medicine production sector for the simplified registration of herbal medicines.
Contribution deadline: March 04, 2025

Consulta Pública ANS No. 144/24: Receive contributions to the proposed changes for Normative Resolution No. 506 of March 30, 2022, which establishes the Certification Program for Good Practices in Healthcare of Private Healthcare Plan Operators.
Contribution deadline: January 23, 2025

ANS Public Consultation No. 145/24: Receive contributions on Regulatory Impact Analyses (RIA) and Regulatory Result Assessments (RRA) regarding matters involved in the Pricing and Price Increase Policy, namely:
• Price increases and contract termination in group policies;
• Financial regulation mechanisms;
• Online sale and technical review, as provided for through Normative Resolution No. 548 of October 10, 2022.
Contribution deadline: February 03, 2025

ANS Public Consultation No. 146/24: Receive contributions on the preliminary recommendation for incorporation of the technology contained in UAT (Technical Analysis Unit) No. 141 – Bimekizumab.
Contribution deadline closed on January 21, 2025

ANS Public Consultation No. 147/24:  Improvement of the oversight model adopted by ANS.
Contribution deadline: March 07, 2025

SECTICS Public Consultation No. 97/24: Proposal to update the Clinical Protocol and Therapeutic Guidelines for Anemia in Chronic Kidney Disease.
Deadline for contribution closed on January 07, 2025

SECTICS Public Consultation No. 98/24: Clinical Protocol and Therapeutic Guidelines for Iron Deficiency Anemia.
Deadline for contribution closed on January 07, 2025

SECTICS Public Consultation No. 99/24: Migalastat for the treatment of adult and adolescent patients aged 12 years or older with a confirmed diagnosis of Fabry’s disease and with a susceptible gene mutation.
Deadline for contribution closed on January 07, 2025

SECTICS Public Consultation No. 100/24: Deferiprone for the treatment of iron overload in sickle cell disease.
Deadline for contribution closed on January 07, 2025

SECTICS Public Consultation No. 101/24: Memantine hydrochloride oral solution and orodispersible tablet for the treatment of moderate to severe Alzheimer’s disease in patients with dysphagia.
Deadline for contribution closed on January 07, 2025

SECTICS Public Consultation No. 102/24: Rituximab, dapsone, and romiplostim for the treatment of patients aged 1 to 17 years with primary refractory or corticosteroid-dependent idiopathic thrombocytopenic purpura.
Deadline for contribution closed on January 07, 2025

SECTICS Public Consultation No. 103/24: positron emission tomography and computed tomography (PET-CT) / staging of patients with locally advanced esophageal carcinoma (cancer).
Contribution deadline: January 20, 2025