Anvisa announces initiatives to promote access to new medications

The publication addresses advancements, challenges, and proposals for clinical research and innovation in the pharmaceutical sector.

On December 12th, Anvisa released the document Reflexões & Perspectivas: Regulação, Pesquisa Clínica e Inovação (Reflections & Perspectives: Regulation, Clinical Research, and Innovation), which outlines the Agency's strategy and guidelines to strengthen the clinical research ecosystem and health innovation in Brazil.

The Report highlights advancements such as regulatory modernization and support for new medications, as well as future plans like creating a regulatory science center and expanding clinical trials.

Focusing on safety, efficacy, and global competitiveness, Anvisa aims to collaborate with various sectors to drive innovation and strengthen the national healthcare system.This initiative is part of the Agency's commitment to promoting the health of the Brazilian population by encouraging the development and innovation of new medications.

In this context, Director Meiruze Freitas, at the end of her term leading the Second Directorate, shares this comprehensive document, reflecting the strategic vision developed over the past years.

Key initiatives highlighted include:

• Revision and modernization of regulatory frameworks for clinical research and drug registration;

• Simplification and flexibility of the regulatory framework for biosimilars;

• Launching public calls for technical and scientific guidance and support;

• Development of strategic partnerships, such as creating a center dedicated to Regulatory Science;

• Strengthening national capacities for conducting clinical research.

By aligning its regulatory efforts with other actors in the innovation ecosystem, Anvisa contributes to a more resilient and innovative Brazilian healthcare sector.

See below the summary of the report published by ANVISA:

• Summary of the Document “Reflexões & Perspectivas: Regulação, Pesquisa Clínica e Inovação,” published by ANVISA in December 2024 

  
  

Editorial

The editorial presents the document Reflexões & Perspectivas: Regulação, Pesquisa Clínica e Inovação, which outlines strategies to strengthen the clinical research ecosystem and promotes health innovation in Brazil.

While reflecting the authors' vision, the text highlights Anvisa’s role as a catalyst for innovation and global competitiveness, ensuring the safety and efficacy of health products.Advancements include public calls for innovation, regulatory modernization, and flexibility for access to therapies.

Next steps: create a Regulatory Science Center, strengthen clinical research, and attract trials to Brazil.Partnerships with universities, industries, and the government are essential to promote health and innovation.

Executive Summary

The document details Anvisa’s strategies, challenges, and opportunities to strengthen the regulatory environment for clinical research in Brazil, consolidating its position in the global health innovation scenario.

Presentation

Anvisa celebrates 25 years of clinical research regulation and highlights actions to promote technological innovation in the pharmaceutical sector. The goal is to improve the regulatory environment and to position Brazil as a global leader in health research and innovation.

Context

• Recent advancements: The COVID-19 pandemic accelerated the need for rapid and efficient responses, especially for the registration and regulation of new technologies, such as advanced therapies and medications for rare diseases.

• Challenges: Modernizing regulatory approaches to meet the growing demand for innovation while maintaining safety and efficacy standards.

Strategic Objectives (2024-2027)

1. Ensure safe access to essential health products.

2. Foster the development of promising technologies.

Strategic Challenges

• Ecosystem: Identify and enhance innovation opportunities.

• Global Position: Strengthen Brazil’s competitiveness in conducting clinical trials.

Advancements and Initiatives

1. Regulatory modernization: Revision of RDC No. 945/2024 and implementation of standards to streamline analysis and reduce bureaucracy.

2. Good Clinical Practices: Ensure compliance with international standards to protect participants and ensure reliable data.

3. Innovation and learning: Incorporate lessons from the pandemic to create a more efficient and innovative ecosystem.

   
   

Brazil's Potential

• Ethnic diversity, demographic relevance, and healthcare infrastructure (SUS) make the country attractive for clinical research investments.

• National and international partnerships can drive the development of new therapies and technologies.

Diagnosis of the Current Clinical Research Scenario in Brazil and WorldwideNational Scenario:

The promulgation of Law No. 14.874/2024 marks a step forward in regulating clinical trials in Brazil, with actions that encourage collaboration between public and private sectors for innovation and national production for SUS. Brazil ranks 19th globally in clinical research but still faces challenges such as approval timelines and lack of predictability.

Anvisa regulates clinical trials, and Brazil stands out for its large population, ethnic diversity, qualified workforce, and integration with SUS and the pharmaceutical market. The country has the potential to be a world leader in clinical research, with Anvisa aligned with international practices.

International Scenario: Clinical research is essential for achieving the Sustainable Development Goals (SDGs), especially in universal access to health and medications. Brazil can draw inspiration from international agencies such as the FDA and EMA, which have implemented programs to accelerate the approval of innovative treatments.

The UK and PAHO are also developing programs to increase regional drug production and strengthen regulatory capacity. Furthermore, regulatory authorities are modernizing their technological infrastructure and collaborating to improve interoperability and accelerate drug development.

These practices can serve as models for Brazil, strengthening the research environment and attracting more investments and clinical trials.

Recent Advancements and Completed Actions

• Recent regulatory advances and actions by Anvisa include the creation of the Technical Chamber for Clinical Research (Catepec), established by Joint Ordinance 2, aimed at strengthening and modernizing the regulatory environment in Brazil.

Catepec provides technical-scientific support to Clinical Research coordination for Medications and Biological Products and Health Products, promoting efficient analysis of clinical trials, monitoring technological innovations, and improving decision-making processes.

• Expected impacts include faster approval processes, improved evaluation quality, and a stronger innovation environment in the health sector. Anvisa also published the 2023 Annual Activity Report and the 1st Annual Report on Good Clinical Practices (BPC) Inspection Metrics, highlighting compliance with BPC and transparency in inspections.

• Regulatory modernization is another significant advance, with the publication of RDC No. 945/2024 and IN No. 338/2024, which update guidelines for conducting clinical trials and promote more efficient and less bureaucratic analysis, focusing on the safety and efficacy of medications, encouraging new investments in the country.

Ongoing Projects:

1. Regulations for free access to treatments: The public consultation (CP 1.210/2023) aims to review assistance programs and simplify processes, focusing on risk analysis and accelerating access to treatments.

2. WHO audit for Anvisa qualification: Anvisa seeks recognition as an International Reference Health Authority by WHO, ensuring that clinical trials in Brazil follow international quality and safety standards.

3. Guidance for innovations in medicines: A public call aims to support the development of new medications in Brazil, including phytotherapies, synthetics, and biologics, aligning with national innovation and health guidelines.

4. Guidance for advanced therapy in Brazil: Developers of advanced therapy products will receive regulatory guidance to ensure the safety and quality of products intended for SUS.

5. Partnerships in progress: Anvisa is forming partnerships with public and private institutions to develop and apply standardized approaches for clinical trials, specialized training, and well-structured research centers. Cooperation with organizations such as EBSERH, Fiocruz, and universities aims to strengthen clinical research and the innovation ecosystem, promoting a favorable environment for the approval of clinical studies and drug registrations.

Actions to Improve the Regulatory Environment for Clinical Research in Brazil:

1. International Cooperation and Regulatory Trust: Increase collaboration with global regulatory agencies to align Anvisa’s practices with international standards, fostering a more efficient and dynamic environment.

2. Equivalence Analysis and Trust-Based Approvals: Implement procedures to accelerate the approval of clinical trials based on equivalent international decisions without compromising safety.

3. Collaboration Agreements and Exchange Programs: Expand agreements with reference agencies (FDA, EMA, etc.) and promote exchanges to empower Anvisa staff with best practices.

4. Automation and Use of Advanced Technologies: Invest in digital systems and AI tools to speed up processes, improve data management, and predict safety risks.

5. Capacity Building and Sectoral Dialogue: Promote greater interaction between Anvisa, the pharmaceutical industry, and academia, and invest in continuous staff training.

6. Good Manufacturing (BPF) and Laboratory (BPL) Practices: Ensure that experimental medicines and non-clinical studies follow BPF and BPL to strengthen data quality and integrity.

7. Human Resources Qualification: Expand Anvisa’s specialized team to handle the increased complexity of clinical trials and health innovations.

8. Creation of an Innovation Support Structure: Establish regulatory support for startups and pharmaceutical companies, including advisory and educational programs, to foster the development of new therapies.

9. Regulatory Science Centers: Create centers dedicated to regulatory research and education to strengthen collaboration between government, academia, and industry, boosting innovation in Brazil.

Expected Impact:

• Greater predictability in the development of new products.

• Attraction of investments and strengthening of startups.

• Strengthening scientific and technological capacity, consolidating Brazil as a global innovation hub.

CONCLUSION

Anvisa plays a crucial role in strengthening public health and Brazil's economy by promoting access to new therapies and stimulating technological innovation. By creating flexible regulatory frameworks, the agency encourages the development of emerging technologies and ensures the quality of clinical trials. Partnerships with academic institutions and the pharmaceutical industry are key to advancing research and attracting investments, putting Brazil in the spotlight on the global health innovation stage.