Life Sciences Newsletter | May 2024

Check out our monthly Life Sciences Newsletter, which gathers information about recent legislation, news, public consultations, and bills concerning the health and agriculture sectors in Brazil.

For more information, please contact our lawyers.

Enjoy reading!

Demarest’s Life Sciences Team

NEWS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Regulatory Impact Analysis Report on Cannabis for medicinal purposes released

On May 15, 2024, ANVISA published the Regulatory Impact Analysis Report on Cannabis for Medicinal Purposes.

The report integrates the revision of the Collegiate Board Resolution (“RDC”) No. 327/2019, which regulates the authorization of cannabis products in Brazil.

In its vote approving the report, ANVISA’s Collegiate Board of Directors emphasized the need for tools to increase the availability of the products, and further details on the application routes and the deadline for completing the procedures, such as imports, for example.

Regulatory Impact Analysis Report for reviewing technical regulations of imported goods and products released

On May 20, 2024, ANVISA released the Regulatory Impact Analysis Report for reviewing technical regulations of imported goods and products.

The report integrates the revision of RDC No. 81/2008, which generally provides for the import of products subject to inspection by ANVISA.

In its vote approving the report, ANVISA’s Collegiate Board of Directors considered that the most suitable measure for updating import regulations is to publish an RDC with general requirements and normative instructions containing specific requirements for each area.

Guide to Good Practices on Human Cells and Tissues for Therapeutic Use released

On May 09, 2024, ANVISA published the Guide to Good Practices on Human Cells and Tissues for Therapeutic Use.

Interested parties can submit contributions for improvements to the practical guide by September 10, 2024.

LEGISLATION

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Regulation amends rules on Operating Authorization and Special Authorization

On May 08, 2024, RDC No. 860/2024 was published, amending the regulations on Operating Authorization (“AFE”) and Special Authorization (“AE”).

The main innovations are as follows:

• provisions that addressed the renewal of AFE/AE were repealed;
• activities and establishments exempt from AFE were expanded;
• Individual Micro Entrepreneurs (“MEIs”) can now apply for AFE/AE, since the Corporate Tax Number (“CNPJ”) card will also be accepted to instruct the application, instead of only the company’s articles of organization;
• amendments to the AFE/AE can be immediately valid upon filing;
• a chapter was included summarizing the stages involved in each production activity, trade, distribution, etc.

ANVISA adopts reliance procedure for granting GMPCs

On May 03, 2024, Normative Instruction (“IN”) No. 292/2024 was published, which provides for the specific criteria and procedures for the definition of Equivalent Foreign Regulating Authorities (“AREE”) involved in the health oversight process of active pharmaceutical inputs, medicinal Cannabis Products, medicines and bioproducts.

The IN also establishes an optimized analysis procedure to obtain the Good Manufacturing Practices Certification (“GMPC”).  Obtaining the GMPC is extremely important for companies operating in Brazil, and the reliance procedure will facilitate the process, given that ANVISA has authorized 42 AREEs in different countries and continents.

Positive list of food additives amended

In May 2024, INS 297/2024 and 303/2024 were published, amending the positive list of food additives and their respective technological purposes, maximum limits and conditions of use, within the scope of IN No. 211/2023.

The amendments have been in force since early June 2024.

Resolution updates regulation for collecting Health Surveillance Inspection Fee

On May 09, 2024, RDC No. 857/2024 was published, which provides for the procedures for collecting revenue from the Health Surveillance Inspection Fee (“TFVS”), carried out by ANVISA.

The RDC consolidates the previous regulations on the TFVS and optimizes the document analysis procedure, especially regarding the analysis of the company’s economic capacity.

These amendments have been in force since June 03, 2024.

Resolution establishes basic guidelines for risk assessment and food safety

On May 17, 2024, RDC No. 868/2024 was published, which provides basic guidelines for risk assessment and food safety.

The proof of safe use will consider data on the chemical composition, formulation of the product and tests in general.

The RDC has been into force since June 03, 2024.

Regulatory framework for medicinal gases published

On May 21, 2024, the regulatory framework for medicinal gases was published, through RDC No. 870/2024, which provides for the notification, registration and post-registration amendments of medicinal gases classified as medicines, and IN No. 301/2024, which establishes the list of medicinal gases classified as medicines subject to notification.

Updated regulations for accreditation to the Sentinel Network published

On May 21, 2024, ANVISA published new regulations on the composition and operation of the Sentinel Network, through RDC No. 872/2024 and IN No. 302/2024.

The Sentinel Network is an active observatory for the performance and safety of regularly used health products, which began in 2001. However, according to ANVISA, the number of members has dropped over the last few years, which has led to the need to update the accreditation regulations.

Biosimilar registration regulations updated

On May 29, 2024, RDC No. 875/2024 was published, which establishes additional provisions on the registration of biosimilars through development and comparability studies.

The RDC updates specific rules of RDC No. 55/2010, which provides for the registration of biological products, in order to include alternatives not previously provided for, especially regarding the strictness of requirements for the submission of animal studies and comparative clinical studies, since the normative text does not allow for these requirements to be waived.

ANVISA establishes inspection guide for pharmaceutical equivalence centers

On May 08, 2024, IN No. 298/2024 was published, establishing the inspection guide for pharmaceutical equivalence centers, and RDC No. 856/2024, which also addresses pharmaceutical equivalence centers, was amended.

According to ANVISA, the purpose of the IN and the RDC is to condition the qualification of a pharmaceutical equivalence center by ANVISA on the conduct of pharmaceutical equivalence or comparative dissolution profile studies by the qualified company, which was not previously provided for.

General regulation on administrative appeals ratified by ANVISA

On May 08, 2024, RDC No. 862/2024 was published, which provides for the assessment and deliberation of administrative appeals before the appellate court, suggestions for withdrawal of suspensive effect, and requests for review of acts through the decision of the Collegiate Board of Directors.

This is a procedural provision that authorizes the reporting boards to request the General Secretariat of the Collegiate Board to register administrative appeals, suggestions for withdrawal of suspensive effect and requests for review of acts through the decision of the Collegiate Board of Directors. This procedure was previously provided for in RDCs Nos. 522/2021 and 525/2021, but the validity of this regulation expired in May 2024.

ANVISA restricts the manufacture and sale of zolpidem and zaleplone-based drugs

On May 21, 2024, RDC No. 871/2024 was published, establishing restrictions on the manufacture and sale of drugs based on zolpidem and zaleplone.

According to the new regulation:

• as of August 01, 2024, prescriptions and dispensing of drugs based on zolpidem and zaleplone must be carried out using Controlled Substance Prescription “B”;
• until December 01, 2024, the manufacture of new batches of zolpidem and zaleplone-based drugs with red packaging will be permitted.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

Regulation on the Healthcare Recovery Plan updated

On May 07, 2024, IN No. 35/2024 was published, which regulates the Normative Resolution (“RN”) No. 485/2022, provides for the Healthcare Recovery Plan, the special technical management regime and the Healthcare Sanitation Program during the special technical management regime.

his IN amends specific aspects of the Healthcare Recovery Plan, previously provided for in IN No. 50/2016, which has been repealed.

MS – BRAZILIAN MINISTRY OF HEALTH

Strategic telehealth action is implemented in SUS

On May 29, 2024, GM/MS Ordinance No. 3,691/2024 was published, which establishes the Digital Strategic Action – Telehealth for the Brazilian Unified Health System (“SUS”).

The action aims to support the consolidation of healthcare networks and the Indigenous Health Subsystem, by establishing guidelines and offering services that foster comprehensiveness and continuity of care between all levels of care in the SUS.

The services will include teleconsulting, teletriage, teleconsultation, telediagnosis and telemonitoring, among others.

FEDERAL GOVERNMENT

Clinical research on human subjects regulated

On May 28, 2024, Law No. 14,874/2024 was published, regulating human subject research in Brazil by public and private institutions, as well as establishing the National Ethics System in Human Subject Research.

The new law establishes the mandatory standards to be followed for human subject research. This research encompasses data, information or biological materials of human subjects, either directly or indirectly, so they are covered by the new law, which will enter into force on August 26, 2024.

PUBLIC CONSULTATIONS AND HEARINGS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Proposal to amend the list of economic activities inspected by health surveillance subject to public consultation

On May 13, 2024, Public Consultation No. 1,249/2024 was opened to receive contributions on the proposal for a draft RDC on the identification and classification of the degree of risk of economic activities subject to health surveillance.

The consultation aims to align the guidelines and procedures for simplifying the process of legalization, authorization, licensing and operation of companies or economic activities that are of interest to health surveillance, so that activities classified as level I and II risk should be exempt from health licensing.

Contributions can be submitted by July 11, 2024.

Proposed resolution on epidemiological surveillance activities in ports and airports subject to public consultation

On May 13, 2024, Public Consultation No. 1,252/2024 was opened to receive contributions regarding the proposal for a draft RDC on conducting epidemiological surveillance activities in ports and airports.

The consultation aims to improve ANVISA’s activities in order to repeal obsolete regulations and introduce improvements following the Covid-19 pandemic.

Contributions can be submitted by July 11, 2024.

Amendment to the inspection guide for Drug Bioavailability/Bioequivalence Centers subject to public consultation

On May 15, 2024, Public Consultation No. 1,253 was opened to receive contributions on the proposed amendment to IN No. 123/2022.

IN 123 approves the creation of the inspection guide for Drug Bioavailability/Bioequivalence Centers, under the terms of RDC No. 620/2022.

Contributions can be submitted by June 28, 2024.

Proposed amendment to clinical trials procedure subject to public consultation

On May 21, 2024, Public Consultation No. 1,257/2024 was opened to receive contributions for the revision of RDC No. 9/2015, which establishes the regulations for conducting drug trials in Brazil.

ANVISA plans to reduce the time taken for analysis by optimizing the analysis procedure, in line with international standards.

Contributions can be submitted by July 04, 2024