Tuesday, July 16, 2024

Clinical Research in Focus: Anvisa’s 2023 Annual Report Highlights Advances and Challenges

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Anvisa, Brazil’s National Health Surveillance Agency, has released its 7th Annual Clinical Research Activities Report, presenting an extensive overview of the clinical research activities related to drugs and biological products conducted in 2023. The report underscores the crucial role of clinical research in the development and registration of new medications, providing essential insights that facilitate the introduction of innovative therapeutic options to the market while driving scientific and technological advancements in the healthcare sector.

The publication of this report aligns with Anvisa’s commitment to transparency and its strategic goal of enhancing the visibility and recognition of its pivotal role in strengthening clinical research in Brazil. The document delves into the regulatory challenges encountered in clinical research and outlines the significant progress made, as well as the ongoing efforts required to overcome future obstacles. By making this information publicly accessible, Anvisa aims to foster a better understanding and appreciation of the complex processes involved in clinical research and the regulatory framework that supports it.

The 2023 report provides a detailed account of the submission and approval processes for Clinical Development Dossiers (DDCM) and Specific Clinical Trial Dossiers (DEEC). Notably, there was a significant increase in the number of new DDCM submissions between 2019 and 2021, primarily driven by the urgent need for COVID-19 vaccines and treatments. This trend continued in subsequent years, with 134 DDCMs submitted in 2023. These submissions include both new drug candidates and drugs already registered in Brazil or other countries being investigated for new therapeutic indications.

Highlighting Regulatory Timelines, Phase 3 Trials, and Expanded Access Programs in Clinical Research

Anvisa adheres to strict regulatory timelines, requiring a 90-day response period for primary and secondary clinical trial petitions. The report highlights an increasing number of petitions approved by default due to the expiration of this timeframe. This trend reflects the growing volume of clinical trials and the corresponding regulatory demands. Additionally, the report outlines the prioritization criteria for clinical trials involving neglected diseases, public health emergencies, and rare conditions, showcasing Anvisa’s dedication to addressing critical healthcare needs through expedited regulatory processes.

The report reveals that Phase 3 clinical trials, which aim to confirm the efficacy and safety of new treatments in larger patient populations, dominated the submissions in 2023, accounting for 64% of DEECs. Oncology remains the primary therapeutic focus, with a substantial number of trials targeting various cancers, including lung, breast, and lymphoma. Other key areas of research include endocrine and metabolic diseases, cardiovascular conditions, and skin disorders, reflecting a broad spectrum of clinical investigation aimed at addressing diverse healthcare challenges.

Anvisa’s commitment to patient access to innovative therapies is evident in its management of programs for expanded access and compassionate use of experimental drugs. These programs provide alternative treatment options for patients with serious, life-threatening conditions who lack satisfactory therapeutic alternatives with registered products. In 2023, Anvisa received 172 requests for compassionate use and approved several expanded access programs, highlighting the agency’s proactive approach in facilitating access to potentially life-saving treatments.

Clinical Research

GCP Inspections and Regulatory Achievements in Clinical Research

To safeguard the rights, safety, and well-being of clinical trial participants and ensure the reliability of collected data, Anvisa conducted nine Good Clinical Practices (GCP) inspections in 2023. These inspections, carried out at clinical trial centers, sponsors, and other involved institutions, are critical for maintaining high standards in clinical research. The findings from these inspections, including 205 observations categorized as critical or major, underscore the importance of regulatory oversight in ensuring adherence to established guidelines and protocols.

Anvisa’s 2023 Annual Clinical Research Activities Report not only highlights the agency’s achievements in facilitating clinical research but also points to the broader implications for public health and scientific innovation. By providing detailed data and analysis, the report serves as a valuable resource for stakeholders in the healthcare and pharmaceutical industries, offering insights into the evolving landscape of clinical research in Brazil. The agency’s ongoing efforts to streamline regulatory processes, prioritize critical clinical trials, and ensure compliance with GCP standards are essential for advancing public health and fostering innovation in drug development.

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Anvisa’s 2023 Annual Clinical Research Activities Report reaffirms the agency’s crucial role in promoting and regulating clinical research in Brazil. Through its commitment to transparency, rigorous regulatory oversight, and support for innovative therapeutic developments, Anvisa continues to facilitate the advancement of new treatments that address unmet medical needs and improve health outcomes for the population. This comprehensive report not only documents the progress made over the past year but also sets the stage for future advancements in clinical research and regulatory practices.

 

Resource: National Health Surveillance Agency, June 04, 2024

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