Natural Sciences Bulletin | May 2024

Check out our monthly Life Sciences newsletter, which brings together information about the latest legislation, news, public consultations and bills affecting the health and agriculture sectors in Brazil.

For more information, please contact our lawyers.

Happy reading!

Demarest Life Sciences Team

NEWS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

A report analyzing the impact of regulations on marijuana for medicinal purposes has been published

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

The report takes into account the revision of Resolution of the Collegiate Council (“RDC”) No. 327/2019, which governs the approval of cannabis products in Brazil.

In the vote approving the report, ANVISA’s collegial board of directors emphasized the need to provide tools to increase product availability and further details on routes for submitting applications and deadlines for completing procedures such as import.

Regulatory Impact Analysis Report on the review of technical regulations for issued goods and imported products

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

The report includes an overview RDC No. 81/2008which generally provides for the import of products subject to ANVISA inspection.

IN in the vote approving the reportANVISA’s collegial board of directors has concluded that the most appropriate means of updating import regulations is to publish an RDC containing general requirements and normative instructions containing specific requirements for each area.

Published Good Practice Guide for Human Cells and Tissues for Therapeutic Use

On May 9, 2024, ANVISA published A guide to good practice for human cells and tissues for therapeutic use.

Stakeholders can comment on improvements to the Practical Guide until September 10, 2024.

LEGISLATION

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

The regulation amends the rules on operational permits and special permits

On May 8, 2024 RDC No. 860/2024 an amendment to the regulations regarding Operational Authorizations (“AFE”) and Special Authorizations (“AE”) has been published.

The main innovations are as follows:

• the AFE/AE renewal provisions have been repealed;
• activities and facilities exempt from AFE have been expanded;
• Individual Micro Entrepreneurs (“MEI”) can now apply for AFE/AE as the Corporate Income Tax Number (“CNPJ”) card will also be accepted to indicate the application and not just the company’s articles of association;
• AFE/AE amendments may be effective immediately upon filing;
• a chapter summarizing the stages of each production, trading, distribution, etc. activity is included.

ANVISA adopts the procedure of awarding GMPC

On May 3, 2024 Normative Instruction (“IN”) No. 292/2024 has been published which sets out detailed criteria and procedures for the definition of equivalent foreign regulatory authorities (“AREEs”) involved in the health surveillance process of active pharmaceutical ingredients, medicinal cannabis products, medicines and bio-based products.

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

The positive list of food additives has been changed

In May 2024, INS 297/2024 AND 303/2024 published amending the positive list of food additives along with their technological purpose, maximum limits and conditions of use, in the scope In No. 211/2023.

The changes are effective from the beginning of June 2024.

The resolution updates the provisions on charging fees for health surveillance inspections

On May 9, 2024 RDC No. 857/2024 has been published which sets out the procedures for collecting revenue from the Health Surveillance Inspection Fee (“TFVS”) operated by ANVISA.

RDC consolidates the existing regulations regarding TFVS and optimizes the document analysis procedure, especially in terms of analyzing the economic viability of the enterprise.

These changes are effective from June 3, 2024.

The resolution establishes basic guidelines for risk assessment and food safety

On May 17, 2024 RDC No. 868/2024 has been published which provides basic guidance on risk assessment and food safety.

Evidence of safe use will include data on chemical composition, product formulation and testing in general.

GDPR is effective from June 3, 2024.

The regulatory framework for medicinal gases has been 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 changes of medicinal gases classified as medicines, and In No. 301/2024which establishes a list of medicinal gases classified as reportable medicines.

Updated regulations for accreditation to the Sentinel Network have been published

On May 21, 2024, ANVISA published new regulations regarding 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 on the performance and safety of regularly used health products, which began in 2001. However, according to ANVISA, membership numbers have declined over the past few years, leading to the need to update the accreditation regulations.

Update of regulations regarding the registration of biosimilar drugs

On May 29, 2024 RDC No. 875/2024 has been published which establishes additional provisions on the registration of biosimilar medicines through development and comparative studies.

RDC updates detailed rules regarding RDC No. 55/2010which provides for the registration of biological products to take into account alternatives that have not yet been envisaged, in particular as regards stringent requirements for the submission of animal tests and comparative clinical trials, since the normative text does not allow derogation from these requirements.

ANVISA establishes inspection guidelines for pharmaceutical equivalence centers

On May 8, 2024 In No. 298/2024 establishing an inspection guide for centers of pharmaceutical equivalence was published and RDC No. 856/2024 was amended, which also applies to centers of pharmaceutical equivalence.

According to ANVISA, the aim of the IN and RDC is to make the qualification of a pharmaceutical equivalence center by ANVISA conditional on the performance of pharmaceutical equivalence or comparative dissolution profile testing by a qualified company, which was not previously provided for.

General Regulation on Administrative Appeals ratified by ANVISA

On May 8, 2024 RDC No. 862/2024 was published, which provides for the consideration and resolution of administrative appeals before the appellate court, applications for the withdrawal of the suspensive effect and applications for review of acts by decision of the Collegiate Board.

This is a procedural provision that authorizes reporting committees to request the General Secretariat of the Collegiate Council to register administrative appeals, proposals to withdraw the suspensive effect, and requests for reconsideration of acts by decision of the Collegiate Board of Directors. This procedure was previously provided for in RDC No. 522/2021 and 525/2021, but this regulation expired in May 2024.

ANVISA restricts the production and sale of drugs based on zolpidem and zaleplon

On May 21, 2024 RDC No. 871/2024 A publication was published establishing restrictions on the production and sale of drugs based on zolpidem and zaleplon.

According to the new regulation:

• from August 1, 2024, prescriptions and dispensing of drugs based on zolpidem and zaleplon must be based on the Controlled Substance “B” Prescription;
• By December 1, 2024, the production of new series of drugs based on zolpidem and zaleplon in red packaging will be allowed.

ANS – BRAZILIAN ADDITIONAL HEALTH CARE AGENCY

Update of the regulation on the Health Recovery Plan

On May 7, 2024 In No. 35/2024 a regulation was published that regulates Normative Resolution (“RN”) No. 485/2022, provides for the Health Care Reconstruction Plan, a special technical management regime and the Health Care Sanitary Program during the special technical management regime.

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

MS – BRAZILIAN MINISTRY OF HEALTH

A strategic telehealth operation is being implemented at SUS

On May 29, 2024 GM/MS Regulation No. 3691/2024 was published, which establishes a strategic digital action – telehealth for the Brazilian Unified Health System (“SUS”).

The action aims to support the consolidation of the health network and the Indigenous health subsystem by establishing guidelines and offering services that support comprehensiveness and continuity of care at all levels of care in SUS.

Services will include, among others: teleconsultations, teletriage, teleconsultations, telediagnostics and telemonitoring.

FEDERAL GOVERNMENT

Regulated human clinical trials

On May 28, 2024 Law No. 14,874/2024 was published, regulating research involving human subjects in Brazil conducted by public and private institutions, and establishing a National System of Ethics in Research Involving Human Subjects.

The new law establishes mandatory standards to be followed in research involving humans. This research involves human data, information or biological materials, directly or indirectly, and is therefore covered by the new law, which will enter into force on August 26, 2024.

PUBLIC CONSULTATIONS AND HEARINGS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

The proposal to change the list of economic activities controlled by sanitary supervision is subject to public consultations

On May 13, 2024 Public consultation no. 1249/2024 was opened to receive comments on the RDC draft proposal on the identification and classification of the degree of risk of economic activities subject to health supervision.

The consultations aim to harmonize guidelines and procedures aimed at simplifying the process of legalization, issuance of permits, issuance of licenses and operation of enterprises or economic activities of interest to medical supervision, so that activities classified as risk categories I and II are exempt from the requirement to issue permits in in the field of health care.

Works can be submitted until July 11, 2024.

The draft resolution on epidemiological surveillance activities in ports and airports is subject to public consultations

On May 13, 2024 Public consultation no. 1252/2024 was opened to receive comments on the RDC draft proposal on carrying out epidemiological surveillance activities in ports and airports.

The consultation aims to improve ANVISA’s work to repeal outdated regulations and introduce improvements in the wake of the Covid-19 pandemic.

Works can be submitted until July 11, 2024.

Change to the inspection guide for Centers for Bioavailability/Bioequivalence of Medicines subject to public consultation

On May 15, 2024 Public consultations no. 1253 the opportunity to receive comments on the proposed amendment to In No. 123/2022.

IN 123 approves the establishment of an inspection guide for Drug Bioavailability/Bioequivalence Centers, in accordance with the terms RDC No. 620/2022.

Works can be submitted until June 28, 2024.

The proposed change to the clinical trial procedure is subject to public consultation

On May 21, 2024 Public consultation no. 1257/2024 has been opened to accept contributions for revision RDC No. 9/2015which sets out the rules for conducting drug research in Brazil.

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

Applications can be submitted until July 4, 2024