MSD
or the second consecutive year, DIA Europe hosted a Latin America Town Hall, a panel discussion to foster collaboration and share updates from regulatory activities in Latin America and Europe, and the intersections between them.
The sophistication of emerging technologies requires more complex regulatory oversight, a challenge for most regulatory systems in Latin America.
Latin America is witnessing substantial growth in both its population and economy, leading to new challenges for regulatory authorities, industry, and other stakeholders. These challenges encompass managing the complexity and increasing volume of products that need to be regulated as well as embracing emerging technologies and responding to evolving healthcare demands.
The most important solution available to face this challenge is the adoption of reliance practices by regulators in Latin America; more specifically, unilateral reliance on trusted authorities (such as those listed by the World Health Organization). ANVISA is among the regulators in this region currently reforming its reliance framework to adapt to international best practices. The process of building the new reliance regulations in Brazil was praised by the panelists for being transparent, comprehensive, and inclusive, encompassing public consultations, open dialogue with the private sector, and benchmarking of global lessons learned. These will help optimize regulatory processes in Brazil, ensuring consistency, relevant regulatory assessments, and efficient reviews.
Learnings from collaboration with Europe has enabled progress in Latin America’s regulatory practices.
Discussions at DIA Europe reflected the consensus that Latin America has learned from the experience of sharing information with the European regulatory system. These experiences inspired and supported the development of local regulations of medical products, contributing to regulatory convergence, the progress of innovation, and better health outcomes.
One illustrative example is the ANVISA-EMA confidentiality arrangement signed in 2021, which is already delivering positive results to both agencies. Through this agreement, the Brazilian agency joined the Opening procedures at EMA to non-EU authorities (OPEN) initiative, a mechanism through which the European regulator works in a collaborative assessment with ANVISA for the registration of a Chikungunya vaccine manufactured in Brazil.
Other international collaborations play a fundamental role in strengthening Latin America’s regulatory systems.
During this Town Hall, ANVISA shared that the agency has formal agreements, memoranda of understanding, cooperation projects, and confidentiality agreements with regulatory authorities in more than 30 countries in all regions of the globe, as well as with various regional and international organizations, including the Pan American Health Organization (PAHO), the World Health Organization (WHO), and EMA. Through their active participation in numerous regional international initiatives, and also in conferences and events (such as DIA Europe), the agency benefits from constant information sharing with other health authorities and different regulatory stakeholders, including industry and patients. Panelists agreed that these measures have greatly contributed to the advancement of regulatory convergence and best practices in Brazil.
Increase regulatory collaboration between Europe and Latin America through further engagement in global regulatory initiatives.
EMA has historically been a reference agency for different health authorities in Latin America. Through the recent expansion of reliance practices in the region, regulators are increasingly eager to not only understand how regulatory science in Europe has been evolving but they also expect to engage in continuous interactions with the EMA on numerous topics. However, it is not sustainable for authorities to rely only on bilateral engagements to respond to every regulatory challenge they may encounter.
EMA emphasized that their current dialogue and exchange with most agencies in the region happens through their mutual participation in initiatives that promote global regulatory dialogue. This happens not only at conferences and events but through global initiatives such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Pharmaceutical Regulators Programme (IPRP), and the International Coalition of Medicines Regulatory Authorities (ICMRA).
However, not all regulators—especially those that are either less mature, located in low-income countries, or represent small markets—are in a position to consistently join such initiatives. There is an increasing need for reference authorities to reach out to regulators that are constrained from full engagement in the global regulatory community and discussions.
Regulatory convergence is one lever for reliance and remains a work in progress in Latin America.
Regulatory convergence and harmonization to internationally recognized standards and guidelines (such as those from WHO and ICH) play a crucial role in establishing consistent regulatory requirements and practices across different regions. Risk-based classification of post-approval changes (PAC) provides a current example. Comparing data from an impact assessment of divergence on post-approval changes classifications in the Latin America region with the regulation from Europe and the US clearly indicates that alignment to international standards could ensure more efficient product lifecycle management and reduce the risk of product shortages to patients. Furthermore, harmonized risk categorization facilitates reliance practices, enables efficiency, and optimizes health authority resources.
There is a role for industry in supporting collaboration among regulators.
As the main “client” of all regulatory authorities, industry rightfully expects to have a continuous and constructive dialogue when it comes to the regulatory requirements and processes in any country or region. In addition to these “local” partnerships, industry associations are also recognized as important players in promoting and supporting regulatory collaboration.
For instance, multinational companies operating in multiple regulatory realities offer a valuable, unique perspective on the level of regulatory convergence across different jurisdictions. They can also help promote understanding among local regulators of best practices and procedures that are being implemented in other countries, based on concrete experiences and lessons learned from others. Examples of this potential for industry associations include the presentation of informative events in collaboration with EMA, such as the webinars on new procedures and policies for the Certificate of Pharmaceutical Product (CPP) presented in 2021 and 2022 and the webinar Regulatory Reliance Tools Unveiled: A Practical Guide by EMA. These events were designed to facilitate reliance on EMA as a trusted regulatory reference authority, with the overall objective of striving for process efficiency and sustainability and communicating simultaneously with numerous regulatory stakeholders.