Latin America Roundup: Regulatory affairs at center of WHO Americas meeting

More regional production of medicines and vaccines, better access to higher-cost technologies, faster progress on regulatory convergence, and controlling the costs of essential medications were some of the key themes of the recent World Health Organization Regional Committee for the Americas meeting in Washington.

Officials from WHO and the Pan American Health Organization joined public health officials from Latin America and the Caribbean at the meeting, which was held from 30 September to 4 October, with each country reporting on their goals and challenges.

Addressing the representatives, PAHO director Jarbas Barbosa identified accelerating regulatory convergence as a priority to facilitate regional production of medicines and devices. No national regulatory authority in the region is, as of yet, a WHO-listed authority, a designation representing the highest global standard, Barbosa pointed out. Currently the national agencies of Chile, Mexico, Argentina, Cuba, Brazil and Colombia have been designated National Regulatory Authorities of Regional Reference, a lesser designation, by WHO.

“I think in Latin America and the Caribbean, through effort and technical cooperation, we can by 2025 and 2026 have more regulatory authorities achieving that level as well the highest level,” Barbosa said. “That’s extremely important because in order to strengthen production regional production in Latin America and the Caribbean the regulatory issue is paramount. To be able to produce products and export them, having the highest rating is key,” he said, adding that PAHO “is working with regulatory authorities to support them in a process of self-evaluation using the same tools used by WHO.”

During the meeting, FIFARMA, the trade group representing pharmaceutical manufacturers across Latin America, issued a statement urging member states to improve regulatory standards wherever possible and adopt more reliance measures in the meantime.

“[M]ature regulatory systems are vital,” the group said, noting that 8 national regulatory authorities in the region “still need to adopt continuous improvement plans to be recognized by WHO. In addition, 40% of member states do not perform all of the recommended regulatory functions, which makes it necessary to strengthen the systems with international standards.” FIFARMA also said the region and its regulators need to do better in prioritizing clinical research.

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Birth control pills recalled in Chile

In an episode that evoked the 2021 scandal in which faulty oral contraceptives were distributed through public pharmacies, resulting in unwanted pregnancies, Chile’s Institute for Public Health (ISP) issued a recall notice for one lot of birth control pills on 26 September. In this case, improper packaging resulted in the placement of some placebo pills – or at least pills that are the same color as the placebo pills -- in the portion of the monthly blister packs that are supposed to contain pills with active ingredient. The recall initially covered only one lot of the medication, manufactured in India and marketed as Zinnia P by Mylan Laboratories, a global generic drug maker. The medication was imported to Chile under special authorization, using funds from a United Nations program. It was cleared by an ISP lab in May 2023. In its 26 September notice, ISP also published the full inspection report, which saw no evidence of mispackaging in the samples studied.

On 1 October the ISP expanded its alert to cover three different lots of the medication.

Notice (Spanish)

Brazil publishes English-language reliance guidance, floats “regulatory sandbox”

The Brazilian Health Regulatory Agency (ANVISA) published on 27 September extensive details in English on its regulatory reliance initiatives adopted earlier this year, and how entities can comply with them. The document includes information on how information from what it calls Equivalent Foreign Regulatory Authorities (AREE) can be used in support of new marketing authorizations or post-registration changes for drugs and other health products and how its “optimized analysis” process works. It also includes an extensive checklist describing the documentation required for the process.

On 30 September, ANVISA described, in a separate statement, a public webinar on the establishment an experimental regulatory model dubbed the regulatory sandbox. Under this model, companies could “receive temporary authorization … to develop, produce and/or market innovative products and services, subject to health surveillance.” The idea, the agency said, is to promote mechanisms “for the appropriate regulatory treatment” of innovative products and services “in cases where the current regulatory framework makes it impossible to obtain the evidence necessary to regulate these products and services.” The sandbox model was proposed in the agency’s most recent strategic plan, and its 2024-2025 regulatory agenda.

The concept, which first emerged a decade ago in the UK financial sector, has been used by different types of regulatory agencies around the world. In the UK and the US, it has been used to support the development of novel digital health products and strategies. ANVISA did not detail what categories of products or services would be part of any regulatory sandbox experiment.

Statement 1, 2 (Portuguese)

Mexico publishes on regulatory diplomacy as COFEPRIS remains headless

Without yet having named a replacement for Alejandro Svarch Pérez, the top regulator who left the agency at the end of September, Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) has published a series of papers in a government journal describing its “regulatory diplomacy” of recent years – an effort led in large part by Svarch Pérez.

In the latest issue of Revista Mexicana de Política Exterior, Svarch Pérez and a host of COFEPRIS officials describe, in English and Spanish, the agency’s efforts, many of them coordinated with its foreign ministry, in aligning its goals with those of other Latin American countries. In different essays the authors describe specific efforts aimed at: improving regulatory science, including with a new Mexico-based international regulatory school; preventing and targeting corruption in regulatory agencies; promoting regional self-sufficiency; and achieving cooperation on vaccines during health emergencies.

Whether the next COFEPRIS head will be as active in these efforts as Svarch Pérez remains to be seen; however, it is likely that, given his influence, Mexican President Claudia Sheinbaum will not make the mistake of appointing an inexperienced or inappropriate person to the role, according to an analysis in El Economista, the country’s financial newspaper of record. Until one is appointed, COFEPRIS will remain stymied in issuing new import permits, authorizing clinical trials, and new marketing authorizations, as these processes must be overseen by an authorization committee that cannot make decisions without a formal director in place.

Revista Mexicana de Política Exterior

Latin America Roundup: Regulatory affairs at center of WHO Americas meeting

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