Licks Attorneys analyzes the impact of Brazil's new clinical trials legislation

June 11, 2024

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Regulatory Focus

The Brazilian government has changed its laws governing clinical trials following a yearslong legislative process and extensive consultation with the Brazilian Health Regulatory Agency (ANVISA).

Sweeping new legislation signed 28 May, which comes into effect 26 August, consolidates existing regulations on clinical trials, establishes a new national ethics system for trials, decentralizes some aspects of ethical oversight, speeds review of protocols, and adds more detailed and specific provisions aimed at protecting trial participants.

Under the new law, local ethics committees may approve protocols for trials without review by a national committee as before. Multi-site trials will no longer need separate ethics committee approvals for each site. And trial protocol reviews must be completed within a month.

The law carefully outlines the responsibilities of sponsors and investigators to their subjects, including mandating that care be provided to participants harmed by participating in research. The legislation also details how data and biological materials from patients can be used, including allowing patients to withdraw consent for the use of their materials at any time, according to an analysis by Brazil’s Licks Attorneys and Brazilian media reports.

Compensation criteria for healthy subjects in Phase 1 or bioequivalence studies are detailed, and the law now guarantees post-trial access to experimental medications for study participants until such medicines become available through Brazil’s public health system. Previously, a sponsor had to provide study drugs before regulatory approval in Brazil and for 5 years afterwards.

Approximately 10,000 clinical studies were registered in Brazil as of April 2024, making the country the trials leader of Latin America, followed by Mexico with about 5,000 and Argentina with 4,000.

Law (Portuguese)

ANVISA streamlines rules on biosimilars

Brazil’s ANVISA agency said on 28 May that it has updated and simplified rules on biosimilar medications following a 45-day public consultation period. The new regulation results from “a worldwide movement to adapt the regulatory framework for biosimilars,” the agency said in a news release, and “will make it possible to waive some specific steps and studies, when technically feasible, promoting a transparent and predictable regulatory environment for the sector.” Comparator products for biosimilar studies may now be acquired from other countries, the agency said, if none are available in Brazil. Moreover, according to an analysis of the rule by attorneys with the Brazilian law firm Kasznar Leonardos, when no national or international comparator product is available for a bridging study, the agency will consider decisions by what it deems equivalent foreign regulatory authorities, which include the European Medicines Agency and the US Food and Drug Administration.

In further harmonization news, the agency also announced on 6 June that it had been re-elected to the Management Committee of the International Council for Harmonisation (ICH) through 2026. ANVISA, a full regulatory member of ICH, has served on its management committee since 2019 and is the only Latin American agency represented on that committee. In a news release, the agency said it has been expanding both its participation in the ICH and also its implementation of ICH guidelines in Brazil as part of a commitment to regulatory convergence.

ANVISA (Portuguese)

Mexico authorizes nationally developed COVID vaccine

Regulators with Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) announced on 6 June that they had approved, under emergency-use provisions, the first Mexico-developed COVID-19 vaccine, called Patria. The vaccine, based on technology created by the Icahn School of Medicine at Mount Sinai in New York, was developed jointly by the Mexican government and the Mexican veterinary vaccine manufacturer Avimex, and tested clinically in Mexico. The development process began in 2021, and while some doubts have been expressed the vaccine’s likely efficacy compared with commercially available imported products targeting the latest variants, the move nonetheless marks an important return to domestic human vaccine manufacturing by Mexico. Patria is expected to be ready for use in the next national vaccination campaign.

COFEPRIS (Spanish)

Paraguay medicines agency seeks WHO distinction, merger with food agency

Regulators with Paraguay’s National Directorate of Health Surveillance (DINAVISA) announced on 29 May that the agency seeks to be recognized as a National Regulatory Authority of Regional Reference by the World Health Organization (WHO) and Pan-American Health Organization (PAHO), and that its director, Jorge Iliou, had met with WHO and PAHO officials to present on the agency’s progress.

DINAVISA said it hoped to achieve the distinction within a year and that it is surpassing requirements to the degree that “could even position it as a future management model for other health authorities at the same level,” the agency said in a statement. In 2023, DINAVISA also stated its intentions to gain this recognition and solicited technical support from PAHO to improve its technical capacity. Currently the medicines agencies of Argentina, Mexico, Brazil, Colombia, Chile and Cuba are designated by WHO and PAHO as National Authorities of Regional Reference.

On 5 June, a Paraguayan news outlet, ADN Digital, quoted Iliou as saying that the agency is also seeking to merge with the country’s National Institute of Food and Nutrition (INAN) as a way of fortifying its regulatory capacity, improving its ability to respond to emergencies, and avoiding duplication of technical responsibilities. The new agency would be modeled after Brazil’s ANVISA or the US Food and Drug Administration, he said.

Paraguay’s president, Santiago Peña, recently underscored his government’s commitment to strengthening DINAVISA. In a 6 June speech before a Latin American pharmaceutical industry forum held in the Paraguayan capital of Asunción, Peña said that Paraguay “will do our part with clear rules, predictability, macroeconomic stability, and political stability” and that the independence and “institutional strengthening” of DINAVISA was key for the pharmaceutical sector’s continued development.

DINAVISA, presidential statement (Spanish)

Argentina ascends at ICH

Argentina’s National Administration of Drugs, Foods and Medical Devices said on 7 June that it had be accepted as a regulatory member of the ICH, making it the third Latin American agency after Mexico and Brazil with that status. ANMAT has been an observer member of the organization since 2019, has implemented several of its guidelines, and takes part in five of its working groups. As of publication, ICH had not updated its website to reflect Argentina’s changed status.

ANMAT (Spanish)

© 2024 Regulatory Affairs Professionals Society.

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