Latin America Roundup: El Salvador merges regulatory branches to create super-agency

Legislators in El Salvador announced 13 November that they had succeeded in their bid, backed by the country’s president, to create a single national agency responsible for regulating medicines, medical devices, cosmetics, food and beverages, along with veterinary and agricultural products.

The new entity, to be called the Superintendencia de Regulación Sanitaria, or Superintendency of Health Regulation, will have authority over the country’s National Directorate of Medicines (DNM) and its Higher Council for Public Health (CSSP). The DNM will continue to regulate medicines, active pharmaceutical ingredients, devices and clinical trials as part of the Superintendency. Responsibility for foods, agrochemicals and veterinary products, and alcohol and tobacco – currently regulated by different agencies -- will also be absorbed into the new entity, a process that is expected to take more than a year.

The idea is to align El Salvador’s regulatory infrastructure with that of countries like Mexico and Argentina, both of which have large agencies with complex portfolios of responsibilities, legislators told the Salvadoran press.

 Another objective in creating the new, centralized agency, according to statements by lawmaker José Urbina, who led the effort in the legislature, is to have a regulatory body better powered to protect the population from falsified and illegal products. The new institution “will be strong enough to detect products that endanger the population, and there will be better vigilance of everything that is available on the market,” Urbina said.

DNM head Noe García echoed those sentiments in a separate statement, noting that as a broad array of products “directly or indirectly affects the health of the population,” its officials, along with lawmakers, sought to create “a single institution that is stronger and more robust.”

García said that the initiative to create the larger agency stemmed from a two-year-old reform effort at the DNM to streamline processes and reduce response times.

El Salvador Assembly Announcement (Spanish)

Mexico joins MDSAP, seeking to further reliance on device regulation

Officials with Mexico’s Federal Commission for the Protection against health Risks (COFEPRIS) announced 8 November that the agency had become an affiliate member of the Medical Device Single Audit Program, which allows a single audit of a medical device manufacturer to satisfy the requirements of all participating regulatory jurisdictions.

Currently Brazil’s National Health Surveillance Agency (ANVISA) is the only Latin American regulatory agency with full membership in MDSAP, alongside Canadian, US, Australian and Japanese agencies. Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) is an affiliate member.

Amina Achaibou, Cofepris’s director for international affairs, noted that Mexico is already a signatory to two international trade agreements containing provisions for medical devices, and that the latest device supplement to Mexico’s pharmacopoeia (FEUM), published in April 2023, greatly facilitates ongoing efforts toward reliance.

The supplement contains “several key improvements,” Achaibou said, including aligning the definition of a “medical device” with the International Medical Device Regulators Forum (IMDRF), improving risk-based classification criteria and introducing changes to marketing authorization guidelines. In recent years, COFEPRIS has sought to help Mexico become a regional leader in the production and export of medical devices, including recently increasing its staff of device experts by more than one-third.

COFEPRIS Statement (Spanish)

Argentina, Brazil sign convergence accord for low-risk devices

Argentine health officials on 8 November announced a first-ever mutual recognition agreement on medical devices with Brazil. The agreement allows for mutual regulatory reliance with lower-risk categories of devices and diagnostics (FDA class 1 and 2 devices, and class A and B in-vitro diagnostics).

The agreement came as part of a sweeping collaboration initiative signed by the two countries’ presidents in June. At a signing ceremony attended by Brazil’s ambassador and regulators with ANMAT and ANVISA, Argentina Health Minister Carla Vizzotti called the device accord “important not just for each of our countries but also for the whole region … and for the role of our regulatory agencies in the Pan-American Health Organization (PAHO).”

ANMAT Statement (Spanish)

COFEPRIS simplifies scheme for minor modifications

Mexico’s COFEPRIS agency said 13 November that it had implemented changes to make it easier to update administrative data on certain licensed products, using a classification scheme similar to that used by other regulatory agencies of reference, including the US Food and Drug Administration (FDA).

Post-approval updates are now classified by COFEPRIS as minor, moderate and major. Minor updates include changes of legal address or the addition of a distributor, while major changes include alterations to the chemical composition of a product. The scheme, first rolled out in late August, currently applies to biologic medications, vaccines and vitamins but will be expanded to other product categories. In a news release announcing the change, the agency said that about 200 modifications were made using the new criteria over a 40-day period.

COFEPRIS News Release (Spanish)

Chile deploys Moderna’s new monovalent COVID vaccine; Mexico gets more Sputnik

On 17 November, Chilean health officials received about 173,000 doses of Moderna’s Spikevax XBB 1.5 monovalent vaccine against COVID-19. Chile, which last year used a bivalent Moderna vaccine in its public program, is the first Latin American country to administer the new monovalent vaccine, which was granted emergency use authorization by regulators with its Public Health Institute (ISP) on 3 November and is effective against currently circulating Omicron variants.

The government said it planned to begin administering the vaccine, under the auspices of its national vaccination program, as soon as 20 November. They plan to administer the vaccine to higher-risk populations, including people over the age of 60, health professionals and immunocompromised individuals.

On 17 November, regulators in Mexico announced the arrival of 600,000 more doses of Russia-made Sputnik vaccine, which along with a Cuban-manufactured COVID-19 vaccine, Abdala, appears likely to form the cornerstone of its public vaccination campaign. Mexico maintains millions of doses of these vaccines, which remain under emergency use authorization. The government’s continued acquisition of the two vaccines has generated controversy, as neither has been fully assessed by the World Health Organization (WHO).

COFEPRIS in recent weeks gave the initial nod to two up-to-date Pfizer and Moderna COVID-19 vaccines for regular marketing authorization. However, neither of these products has been approved yet in Mexico and it remains uncertain whether they will be integrated into the public campaign.

Chilean Health Ministry Statement (Spanish)