Meeting Highlights: DIA Latin America Regulatory Conference 2022
two hands, one with a medical symbol and the other with a scale
Regulatory Convergence and Other Best Practices in Caribbean & Latin America

ollaboration, convergence, and other best practices have been at the center of discussions related to the regulatory environment in Latin America and the Caribbean, including DIA’s Latin America Regulatory Conference (LARC) 2022, where voices from global regulators, regional and international organizations, industry, and academia discussed the strategies supporting current practices and future trends in regulatory activities in one of the world’s most dynamic pharmaceutical markets.

Good Practices & Convergence: Building Stronger Regulatory Systems in the Americas

Regulatory systems play a crucial role in health systems by ensuring that medicines and other health technologies (including vaccines, blood and blood products, and medical devices) are properly evaluated and meet international standards of safety, quality, and efficacy. To achieve their public health objectives, regulators in Latin America and the Caribbean are increasingly relying on networking, dialogue, and trust, while maintaining their sovereignty and interdependence. Collaboration and cooperation between regulators have positively influenced and strengthened the capacity of regulatory systems in the region, making the best use of their limited resources to address regulatory challenges in a timely manner, including better preparedness for the COVID-19 pandemic response.

As evidenced by the pandemic, the efficient performance of regulators directly influences public health. Among regulatory best practices, one of the key enablers of regulatory efficiency is reliance. It has proven to be useful for different regulatory functions (including market authorization, post-approval changes, and GMP certification) and different types of products, as evidenced by the extensive use of reliance approaches for COVID-19 medical devices, vaccines, and medicines. As regulators in Latin America and the Caribbean expand the use of reliance, experiences from different stakeholders and lessons learned in other regions are considered crucial for proper implementation of local reliance mechanisms. Likewise, tools and opportunities are available to support regulators in the region to further embed fundamental principles of good regulatory practices within their institutions and activities.

Regulatory convergence, another driver for efficiency, takes many forms and represents an effort to improve the transparency and alignment of interactions between agencies and the industry regarding scientific principles, practices, and procedures. Convergence is reflected in the acceptance of internationally recognized technical guidance documents and implementation of regulatory mechanisms. Participation in international or regional regulatory initiatives has been of great significance in building trust, fostering mutual collaboration among health authorities, and enabling more robust regulatory systems, all for the benefit of patients. Regulators from the Americas are increasing their global footprint by developing agendas for international cooperation. For example, the regulatory authorities of Argentina, Brazil, Colombia, Cuba, and Mexico are participants in the International Coalition of Medicines Regulatory Authorities (ICMRA), and COFEPRIS recently joined ANVISA as the second regulatory member of Latin America in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Reliance approaches have been instrumental in allowing easier exchange of information among regulators, fostering greater levels of convergence with internal standards and harmonization of regulatory requirements across the region. Through reliance, regional international organizations, health authorities, research institutions, and industry share their perceptions about the present and future of regulation, which points toward transparent, predictable, and consistent regulatory activity where each contributor can focus their efforts on where they add the best value.

The journey toward greater regulatory efficiency in the Americas has been supported by the regional system for evaluation of National Regulatory Authorities (NRAs), which the Pan American Health Organization (PAHO) has been implementing for more than a decade. This process of NRA assessment and evaluation is based on verification of indicators in a regionally developed data collection tool based on recommendations from the World Health Organization (WHO). Such a system has been used to define NRAs of regional reference in the Americas: currently ANMAT (Argentina), ANVISA (Brazil), Health Canada, ISP (Chile), INVIMA (Colombia), CECMED (Cuba), COFEPRIS (Mexico), and the FDA (US). These regulators are committed not only to enhancing their national regulatory practices and procedures but to helping other regulatory systems in the region become stronger. By promoting regulatory collaboration and influencing regulators to make the best use of their limited resources, PAHO has been playing an important role in supporting increased regulatory capacity in the region.

New Technologies, Changing Mindsets: Broadening Regulatory Horizons toward Innovation

COVID-19 revealed the ongoing need for new ways of thinking about and delivering regulatory effectiveness and efficiency. Scenarios of scarce resources and limited information prompted all stakeholders, especially health authorities, to rethink the margin of risk that the regulator (and society) is ready and willing to tolerate. The need for risk-based approaches in regulatory activities is nevertheless not new nor limited to health emergencies. These systematized decision-making frameworks and procedures not only enable prioritization in regulatory activities (especially in the areas of inspection and enforcement) but also contribute to reliance and collaborative activities among health authorities, allowing for knowledge exchange and continuous improvement. This health emergency proved that proper application of risk-based approaches minimizes the impact of major risks and mitigates minor ones, enabling better resource allocation and accelerating the time to regulatory decision-making. These approaches during the pandemic included rational use of local secondary quality-control testing requirements, remote and desk assessment strategies instead of face-to-face inspection, and Emergency Use Authorizations.

The pandemic also put the medical technology industry at center stage with unprecedented demand for diagnostic test kits and other medical equipment, and extraordinary measures taken to accelerate their manufacturing capabilities. Flexible, risk-based regulatory approaches utilizing remote technologies such as cloud-based monitoring software, telehealth, and virtual site visits have served to optimize clinical outcomes and patient satisfaction. These will be useful to pave the way for future regulation in devices and technology, as regulators and industry face the challenges inherent to the growing relevance of devices enabled by artificial intelligence and machine learning while they witness their positive impact on healthcare across numerous medical fields.

Digital transformation has also accelerated growth of electronic labeling (eLabeling) and product traceability tools during the pandemic. Patients, healthcare providers, regulators, industry, and the environment are already experiencing the benefits of eLabeling, which ensures that necessary information is accessible to all stakeholders in a timely manner and allows for better post-marketing surveillance. Implementation of this digital solution is moving rapidly, with several companies launching pilot projects aimed at better understanding which local adaptations—in digital infrastructure and regulation—are required to allow for global adoption of eLabeling. These pilot programs have been instrumental in providing detailed information for regulatory purposes and highlighting unforeseen challenges for which stakeholders should be prepared when transitioning from paper to electronic labeling, advancing a new digital reality that will enable faster product access during and beyond the pandemic.

Experience and lessons learned from the development and approval of mRNA vaccines in response to COVID-19 again point to the relevance of collaboration and dialogue between industry and NRAs to expedite studies and approvals, and among different NRAs to build trust and apply reliance to deliver medicines to patients rapidly. These lessons have encouraged greater discussion not only on how to improve pharmaceutical manufacturing processes, but on how to increase production capacity for vaccines and other health technologies to promote more equitable access to vaccines across Latin America and the Caribbean. Such enablers include developing local policies that promote innovation and research and development, supported by efficient health authorities that, in close collaboration with industry, rely on a regulatory framework aligned with international regulations and best practices.

Other innovative approaches to bringing transformational treatments to patients with unmet medical needs in Latin America remain at an early stage. Orphan drugs and advanced therapies aimed at treating rare and ultrarare diseases represent one of the fastest growing sectors in the biopharmaceutical commercial markets and offer the promise of personalized treatments. Nevertheless, comprehensive regulatory frameworks are still not a reality in the region, except for Brazil. The complexities of the research and development of such treatments translate into new regulatory challenges, especially for less mature regulatory systems in which regulatory gaps can be more common. There is high value in developing clear regulatory frameworks that favor the correct and rapid evaluation and approval of these treatments, including the application of tools such as real-world data (RWD) and real-world evidence (RWE), which supplement data obtained from clinical trials and provide valuable information for the development, use, and regulation of such products. In such highly complex and ever-progressing circumstances, the benefits of regulatory convergence and reliance by health authorities in Latin America and the Caribbean become even more evident.

Disclaimer: The opinions expressed in this article are solely the authors’ and do not represent the views of their organizations.

This article was written by the following members of the DIA LARC 2022 Program Committee:
Cammilla Horta Gomes, Fernanda Lessa, Gustavo Mendes Lima Santos, Leonardo Semprún, Maria Antonieta Roman, Maria Cristina Mota Pina, Maria Guazzaroni Jacobs, Roberta Mele Mazza, Sonia Viejobueno, Susan Zavala Coloma, and Viktoria Magyar.