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In a meeting with officials at the United Nations Population Fund, Alejandro Svarch Pérez, head of Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS), pointed to regulatory certainty as key to guarantying access to safe, effective, and affordable contraceptives across Latin America and the Caribbean.

Svarch Pérez said the agency’s aims are “to improve the conditions for innovation and technological development, ensure transparency in authorization … eradicate corruption and eliminate anti-competitive practices, and guarantee supplies of health products.” In recent years COFEPRIS has published extensively on its strategies for ensuring regulatory certainty.

Svarch Pérez also noted that regulatory barriers can discourage research and innovation, something his agency has tried to mitigate. Since 2023, he said, COFEPRIS has allowed Mexican condom makers to send their own samples to authorized third-party laboratories for quality testing, rather than the agency carrying out sampling.

While 80% of Latin America and Caribbean is deemed to have good access to contraceptive medicines and devices, according to the UN, a scandal related to faulty contraceptive pills roiled Chilean health officials 2020 and 2021, while regulators across the region are frequently forced to issue alerts about counterfeit or substandard products, among them contraceptives.

Svarch Pérez told the UN officials that harmonization efforts were needed across countries in the region to achieve “uniformity in the requirements” for registrations of medical devices used in sexual and reproductive health, and to “strengthen standardization with pharmacopoeias.” Additionally, regulators in different countries need to be able to share information quickly and effectively, he said.

“To guarantee fair access to health, we need models of regulatory certainty that transcend our borders,” Svarch Pérez concluded.

Statement (Spanish)

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Paraguay regulator accused of extortion

The head of a regional office of Paraguay’s National Directorate of Health Surveillance (DINAVISA) has been accused by prosecutors of participating in a scheme to extort a pharmacy.

The DINAVISA functionary, in collusion with three agents from Paraguay’s antidrug office, made an unauthorized inspection of the business, located in Curuguaty, Paraguy, in June, and alleged that it was out of compliance with documentation related to certain chemicals.

The officials then demanded escalating sums to bring the pharmacy into compliance, while threatening to alert prosecutors if they were not paid, according to prosecutors with the anti-corruption unit of Paraguay’s Attorney General’s office.

Statement (Spanish)

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Lawyers questions whether ANVISA meet deadlines set by clinical trials law

The Brazilian Health Regulatory Agency (ANVISA) is likely to struggle under new deadlines set by sweeping legislation, enacted in May, designed to speed clinical trial ethical and protocol reviews, according to a recent analysis by the Brazilian law firm Licks Attorneys.

The law streamlines ethical reviews, eliminating the need for multiple committees and tightening deadlines. It also sets limit of 90 business days for the “health analysis phase” of protocol reviews. If ANVISA does not act within this time frame, and the trial has already received ethics committee approval, it can proceed, the law says.

While the law was intended to facilitate trials, the attorneys wrote, “It remains questionable whether ANVISA can realistically adhere to the 90-day deadline … for all protocol types.” In 2023, the attorneys noted, average analysis time was nearly 8 months, vastly exceeding legal deadlines at that time. Complicating matters further, they wrote, ANVISA has seen “a significant workforce reduction in recent years.”

The new law, the attorneys wrote, could “engender a cascade of unforeseen complications,” especially if ANVISA demands protocol changes after its review has lagged beyond 90 days and a study is already underway.

“Will studies be interrupted if additions to the protocol are considered necessary by the agency? Will ANVISA not accept data generated from these studies because they were not conducted as the Agency deemed appropriate, despite not having raised any [objections]? Such uncertainties pose significant risks to sponsor investments,” the attorneys wrote.

Lexology (English)

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Cuban regulators build ties to African agencies

While regulatory agencies in Latin America have participated in an increasing number of regional exchanges and harmonization efforts, one agency, Cuba’s Center for State Control of Drugs, Equipment and Medical Devices (CECMED) has also been busily forging ties with its counterparts in Africa.

In 2023, CECMED officials signed a memorandum of understanding in Angola with the country’s Regulatory Agency for Medicines and Healthcare Technologies (ARMED), an entity established in 2021 to carry out pharmacovigilance and licensing of pharmaceuticals and devices, as well as facilitate local manufacturing. The outreach effort was recently furthered with an April 2024 meeting of Angolan and Cuban officials in Cuba.

In a 31 July interview with Prensa Latina, a Cuban government media outlet, Cuban Health Minister Alberto Pinto was quoted as saying that the regulators were “making progress at the usual pace” on the MOU’s agenda. The Angola-Cuban MOU, according to the same article, identifies areas of cooperation related to clinical trials, quality control, “pharmaceutical logistics, pharmacoepidemiology and pharmacoeconomics.” Cuba and Angola have a relationship that dates to the 1970s, when Cuban soldiers were dispatched to fight in Angola’s civil war.

CECMED also met with Rwandan health officials in Cuba to discuss regulatory collaboration, according to the Cuban agency, and signed an MOU with regulatory authorities in Egypt.

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COFEPRIS approves commercial sale of Paxlovid, clinical trial in trans women

In a 1 August statement, COFEPRIS announced it had authorized the sale of Pfizer’s COVID-19 treatment Paxlovid (nirmatrelvir/ritonavir) in Mexico. COFEPRIS said that it had collaborated with the manufacturer on this authorization “with the aim of expanding available treatment options for COVID-19.” COFEPRIS had first issued an emergency use approval of Paxlovid in 2022, after which it became available only through public-health channels. The decision to allow pharmacies to sell the drug parallels its decision in December 2023 allowing for the commercial sale of Pfizer and Moderna COVID-19 vaccines.

On 9 August, COFEPRIS announced it had authorized a clinical trial evaluating interactions between hormone therapy with estradiol and three different HIV drug combinations in trans women. The agency did not name the entity conducting the trial, saying only that “gender affirming therapy is important because it contributes to better quality of life and adherence to HIV treatments in trans women. Evaluation this interaction will help support therapeutic options and enhance the well-being of this group of patients living with the virus.”