Latin America Roundup: El Salvador and Guatemala meet to boost harmonization efforts

Regulators in Guatemala hosted a weeklong series of meetings with their counterparts in El Salvador to promote regulatory harmonization and technical training related to controlled substances and narcotic drugs, both countries announced. The meetings, which concluded the last week of June and took place in Guatemala City, focused on strengthening human resources of the two countries’ regulatory agencies; streamlining of processes; technical and legal aspects of pharmacovigilance; psychotropic substances and narcotics; imports and exports, and the registration of medical devices, according to a statement from the Guatemalan government.

Guatemala’s Ministry of Public Health and Social Assistance (MSPAS) and El Salvador’s National Directorate of Medicines (DNM) both said the meetings strengthened relations between the neighboring Central American states. A key goal of the meetings was promoting faster and easier registration of products across borders in Central America. “[I]t is necessary for Central American countries to unify criteria on regulatory processes, to strengthen the capacities of each, and in this way develop the technical competencies to respond to requests,” the Guatemalan statement said.

In the same statement, Leslie Samayoa, Guatemala’s Deputy Minister of Health, commented that the ongoing harmonization efforts are meant to “favor users, because if a drug is registered in Guatemala it is subjected to a joint evaluation and can be registered in any of the participating countries.” Francisco Bosco Cortez, executive director of El Salvador’s DNM, noted that strengthening the skills of regulators would also help shorten response times.

Statement (Spanish)

Salvadoran, Colombian regulators sign MOU

Salvadoran regulators also met in June with officials from Colombia’s National Food and Drug Surveillance Institute (INVIMA) and signed a memorandum of understanding that seeks to facilitate information exchange and training between the two countries’ regulators. The goal, El Salvador’s DNM said in a statement, was to “promote the development of collaborative activities … including exchanges of experiences, good regulatory practices, technical assistance, case discussions of products regulated by the parties; as well as technical assistance for post-commercial surveillance and control, import and export controls; pharmacovigilance, technological vigilance, clinical trials, regulatory inspections and control activities.” The agencies also said they hoped to establish a direct channel of communication between them.

The meeting took place in Bogotá, where regulators from different agencies met in mid-June to discuss plans for a Latin American and Caribbean Medicines Agency, a Mexico-led initiative that aims to achieve regulatory convergence regionwide.

Statement (Spanish)

El Salvador destroys 2 tons of unlicensed medications

DNM officials said in late June that they had destroyed some 48,000 unregistered or falsified medical products during the first three months of 2023. The products, totaling 2 tons in weight, represented nearly double the amount destroyed during the same period last year, the agency told the government-backed newspaper, Diario El Salvador. Falsified and unlicensed medications – usually common, over-the-counter products but occasionally more sophisticated agents like cancer drugs and devices used in surgeries -- are a regionwide issue and a major focus of multiple regulators’ efforts.

Diario El Salvador (Spanish)

COFEPRIS launches pharmacovigilance center for gender therapies

Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) announced on 29 June that it had created its first pharmacovigilance program focused on LGBTQ+ community health, including gender-affirming therapies and treatments for sexually transmitted infections. The program will operate through three clinical sites in Mexico City, where pharmacy teams have received special training and get regular updates from COFEPRIS, the agency said, allowing for clear and accurate communication with clinicians and patients about drugs, hormonal treatments, individual risk and adverse reactions. The program is the first of its kind in Latin America, the agency said in its statement, and will “strengthen the monitoring of medications for patients receiving hormonal therapies, gender affirmation and treatments against sexually transmitted diseases, such as HIV.”

Also, in late June, COFEPRIS reiterated its commitment to Mexico’s LBGTQ+ community more generally, noting that in recent months it had approved some 14 medical products related to hepatitis and HIV.

Statement (Spanish)

Network of Illegal pharmacies dismantled in Acapulco

A joint intelligence operation by COFEPRIS and Mexico’s Navy helped dismantle a ring of 11 clandestine pharmacies linked to a public hospital in Acapulco, according to a statement from the regulator. The ring appeared to have diverted medical products belonging to the country’s public health sector, of which more than 1,000 were recovered by authorities. A physician was among those arrested in the operation.

Statement (Spanish)

Argentina’s ANMAT bans German firm’s pacemaker, catheter due to theft

Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) has prohibited the use of two medical devices, a pacemaker and a catheter, manufactured by the Berlin-based company Biotronik. In its official bulletin issued 21 June, the agency said that the pacemaker, marketed as Evity DR-T series 70261112, along with the catheter Solia S 60 series 8000645434, were the two products whose use and sale is now prohibited by the agency. The ban, the agency said, stemmed from the company’s Argentina subsidiary reporting a theft.

ANMAT bulletin (Spanish)

New director of Chile’s ISP agency

Chemist Rubén Verdugo has been named head of Chile’s Institute of Public Health (ISP), the agency that also oversees regulation of medicines and medical devices. Verdugo, who was previously the head of the ISP’s environmental division, and most recently a top regulator with the country’s environmental agency, was selected from some 70 candidates.

Press release (Spanish)

Colombia’s INVIMA discourages inappropriate use of semaglutide for weight loss

The GLP-1 agonist drug semaglutide should not be sought for weight loss, according to a statement from the Colombian medicines agency INVIMA, responding to heightened press and social media attention given this class of agents. In Colombia, only one formulation of semaglutide, Novo Nordisk’s Ozempic, is authorized for the treatment of type-2 diabetes. “Weight control in healthy people must be based on adequate lifestyles that include exercise programs and balanced diets,” the agency said in a statement that also cited concerns voiced by the US Food and Drug Administration in recent months about shortages of GLP-1 agonist drugs affecting care for people with diabetes.

Statement (Spanish)

Uruguay adds hemoglobinopathies to neonatal screening panel

Uruguay’s Public Health Ministry (MSP) has added hemoglobinopathies to its national screening panel for newborns. In a 28 June statement, the ministry said that these diseases, which include sickle cell anemia, affect up to four newborns a year in Uruguay. The country’s universal, mandatory neonatal screening program dates to 1994, includes some 25 disorders, and covers 98% of births. Panama, Costa Rica, Brazil also include hemoglobinopathies in their newborn screening programs, though most of Latin America does not.

Statement (Spanish)

Latin America Roundup: El Salvador and Guatemala meet to boost harmonization efforts

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