Latin America Roundup: Negotiations set for creation of regional regulatory body AMLAC

On 26 April, representatives from Mexican, Cuban and Colombian regulatory agencies signed the Acapulco Declaration, formalizing negotiations for the creation of a Latin America and Caribbean Medicines and Medical Devices Regulatory Agency, or AMLAC. Its objective, according to a statement from Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS), is “to advance the self-sufficiency and health sovereignty in Latin America and the Caribbean with shared strategies for health regulation among the region’s countries.”

Currently 10 nations are backing the effort, while Chile, Argentina, and Brazil have thus far declined to join it. FIFARMA, which represents a broad coalition of pharmaceutical industry interests across Latin America, has expressed cautious support for the initiative. Much of the rhetoric around the new agency has taken aim at industry practices in the region, frequently invoking pandemic-era difficulties procuring vaccines and supplies, as well as implicating industry or market behavior in ongoing shortages of essential generic medications. “Health regulation is not a mercantile tool to be wielded in defense of capital, but rather an instrument that has a decisive impact on the drug supply chain in our region,” Alejandro Svarch Pérez, the head of COFEPRIS, said in a statement announcing the signing.

COFEPRIS statement (Spanish)

Colombia prosecutors probe regulatory agency over shortages

Colombia’s National Institute of Food and Drug Monitoring (INVIMA) remains mired in political battles over widespread drug shortages and questions about whether it has exacerbated them. In late April, Health Minister Carolina Corcho, whose agency had oversight of INVIMA, was replaced by Guillermo Jaramillo Martinez; her departure followed that of former INVIMA director Francisco Rossi a month earlier after comments about drug shortages that were seen as dismissive or cavalier. Rossi was officially replaced on 24 April by Mariela Pardo Corredor. The agency’s account of the reasons for and extent of drug shortages differs markedly from those given by industry representatives in Colombia. Colombia’s Attorney General’s office has recently demanded, as part of an ongoing investigation, that INVIMA turn over detailed information on “registration applications for the production, commercialization and import” of specific medicines, along with “personnel in charge of the processes,” and their “plans and strategies to overcome [delays].”

Colombia Attorney General’s office statement (Spanish)

Brazil to allow rapid screening for wide variety of disorders in pharmacies

To expand population access to healthcare services, Brazil’s National Health Surveillance Agency (ANVISA) announced that as of 1 August, a wide variety of rapid clinical tests, currently available only from specialized labs, may be carried out in pharmacies. Under current rules the only rapid diagnostic tests Brazilian pharmacies may conduct are for COVID-19 and blood glucose. The new rules would permit pharmacy-based tissue collection and rapid testing for HIV, dengue, hepatitis, malaria, yellow fever, syphilis and rubella, among other disorders. Participating pharmacies must have their professional staff undergo training and are not expected to provide final word on diagnoses. The pharmacy-based test results “should not be used in isolation for clinical decision-making,” the agency stressed in a statement. These tests should “be used as a triage to provide an objective starting point, in conjunction with routine assessment by healthcare professionals, to provide adequate support to patients. Therefore, the result of a rapid test requires the interpretation of health professionals,” who must evaluate the patient’s clinical data and perform confirmatory tests, the agency stressed.

ANVISA statement (Portuguese)

Danish delegation visits Brazil’s ANVISA to discuss device regulation

ANVISA announced on April 28 that representatives from the Danish Medicines agency (DKMA) had met with its officials in Brasilia to discuss further regulatory collaboration efforts, this time focusing on medical devices. Since 2019 the Danish government has committed funds to fostering what it has described as an effort to support more efficient healthcare management in Brazil, including promoting digitalization strategies to increase activity and reduce waiting time at hospitals, and supporting faster regulation of medical devices and pharmaceutical products.

ANVISA statement (Portuguese)

Mexico announces stronger controls on precursor chemicals

On Friday, COFEPRIS said that a new national law will strengthen Mexico’s ability to more closely track the importation, movement and distribution of equipment and chemicals that can be used in the manufacture of synthetic drugs, obliging entities possessing them to register them within 24 hours. The agency said this will allow the government to better locate diverted chemicals or equipment and make it easier to charge those involved.

COFEPRIS statement (Spanish)

Psychiatric meds standoff nears solution in Mexico, shortages persist

Months after shutting down the country’s largest producer of generic psychiatric medications, COFEPRIS said on Friday that it had reached a solution with the company that would allow some operations to resume alongside greater vigilance of product safety and of movements from production plants to warehouses. The agency said that it was prioritizing the safety testing and release of existing stocks of the company’s lithium carbonate, methylphenidate, clonazepam and methadone. In April, the agency, which has recently begin issuing bi-weekly reports on its approvals, said it authorized 23 medications and 39 medical devices for clinical use, 72 diagnostic devices including reagents and 12 clinical trials. However, other factors contribute to the country’s ongoing drug shortages, which have occurred across a range of clinical specialties.

Mexico-made COVID vaccine submitted for authorization

On 3 May, Mexican officials announced that clinical trial data for the country’s first COVID-19 vaccine, named “Patria,” or Homeland, has been submitted for regulatory approval as a booster shot. María Elena Álvarez-Buylla, director of the National Council of Science and Technology (CONACYT) said in a statement that “thanks to the good results obtained in the different phases of clinical research, and the close collaboration throughout the entire process with [COFEPRIS], it is expected that before yearend, four million doses of the ‘Patria’ vaccine will be produced, a figure that will gradually increase.” The shot, said Álvarez-Buylla, “opens the way for us to recover vaccine sovereignty.” A report from the Associated Press noted that the Patria vaccine, for which development began in 2020, was not originally designed as a booster shot and that Mexico still holds millions of doses of a Cuba-produced COVID-19 vaccine it purchased last year, for which uptake has been slow.

COFEPRIS statement (Spanish)

Dengue vaccine approved in Argentina

Argentina’s National Administration of Drugs, Foods, and Medical Devices (ANMAT) announced on 26 April that it had approved the novel dengue vaccine produced by the Japanese manufacturer Takeda for use in children and adults. Argentina is the second Latin American country to authorize the vaccine following Brazil in March.

ANMAT statement (Spanish)

Latin America Roundup: Negotiations set for creation of regional regulatory body AMLAC

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