The Path to Regulatory Convergence in the Americas

In 2010, the Pan American Health Organization (PAHO), together with its member countries, began to shape the idea of seeking regulatory bridges to generate greater access to quality medicines for the population of the Americas. Between 2011 and 2019, 27 of the 35 National Regulatory Authorities (NRA) of the member states were evaluated, or 77%, thus qualifying the development of regulatory systems. The result was that eight of the agencies could be recognized as high-level, referential, and with mature regulatory systems, thus laying the foundations of an institutional plan that guides the improvement and strengthening of the regulatory systems of all the countries of the American region.

The Administration of Medicines, Food and Medical Technology (ANMAT) of Argentina, the National Health Surveillance Agency (ANVISA) of Brazil, the Center for State Control of Medicines, Medical Equipment and Devices (CECMED) of Cuba, the Federal Commission for Protection against Sanitary Risks (COFEPRlS) of Mexico, the US Food and Drug Administration, Health Canada, the National Institute of Food and Drug Surveillance (INVIMA) of Colombia and the Institute of Public Health (ISP) of Chile are recognized by PAHO and therefore by others as National Regulatory Reference Authorities (NRAr) with a maturity level 4 in the region and provisionally listed on the world list of agencies (WLA) recognized by the WHO at a maturity level 3.

Being recognized as a reference agency, in addition to being a source of pride, is an obligation, a duty to lead the regional transformation and therefore generate plans to determine action priorities according to the regulatory gaps of the country and the region, define realistic objectives and articulate monitoring with mechanisms for continuous improvement, taking evaluation as a reference.

These eight agencies represent 82% of the region's population, but only 23% of the countries, therefore growth has been slow and inequitable.

In turn, in April 2023, CECMED, COFEPRIS and INVIMA (three  of these eight agencies) met in Acapulco, Mexico, to explore and promote the formation of a Latin American and Caribbean Medicines Agency (AMLAC), signing together with representatives of the National Directorate of Medicines (DNM) of El Salvador and the Sanitary Regulation Agency (ARSA) of Honduras the so-called Declaration of Acapulco, in which they called on the rest of the agencies in Latin America and the Caribbean, especially ANMAT, ANVISA and ISP to join the initiative. Months later, in June, the Bogotá Meeting took place, where the six authorities — ANMAT, ANVISA, CECMED, COFEPRIS, INVIMA and ISP —  specified in a document the strengthening of regulatory convergence in the region and invited other agencies and countries to join this challenge.

In the same way, the group of eight NRAr met in Washington, D.C. together with PAHO to define priorities, review the work plan and its progress. At this meeting, the group reaffirmed its commitment to continue being a benchmark and adding other agencies in the region. The need to strengthen the technical teams of the agencies was presented, generating greater confidence.

As can be read in this summary of a long history of hard work, it is not new to want to achieve regulatory integration in our region. It is a desire that not only depends on three or six or eight reference regulatory agencies, it is a job that must incorporate all the agencies of the region, their governments and their pharmaceutical industries.

Regulatory integration requires harmonization, convergence and reliance, three terms used often in regulatory forums and which should be grouped together because separately, technical confidence will not be achieved, the governments' mandate to generate greater ties and products from  the work carried out will fall short, the industry will not be promoted as one in the region and even less will countries be prevented from applying protectionist measures to their markets.

The pandemic highlighted  the harsh reality of the health markets in Latin America and the Caribbean, with problems in the supply chain generating inequities. Countries that achieved rapid access to vaccines effectively reduced excess deaths. One of the success factors on this front was having reference regulatory agencies that shared reports, inspection visits to ensure good manufacturing practices (GMP), and quality reviews. Data transfer was also a nonissue — in fact,  the industry favored the sharing of information between agencies. The same reference regulatory agencies contributed to other health agencies and ministries to finally get ahead as a region. This collaboration was not only apparent in the authorizations of vaccines, but also in facilitating the exports and imports of scarce medicines and medical devices due to the increase in demand and the lower availability of supply.

We have many challenges ahead, among which is to be able to generate a common path, in a direction where all the actors, governments, regulatory agencies, and the pharmaceutical industry, can move toward the achievement of that regulatory convergence that we so long for.