Latin America Roundup: Chile releases new internationally aligned clinical trials guidance

Chile’s Public Health Institute (ISP) has released new guidance on clinical trials that further its efforts to align with international norms.

The guidance was created in consultation with some 240 experts, including industry representatives, the government said in a 14 May statement, and is based on standards published by the International Council for Harmonisation (ICH).

Nicolás Gutiérrez, head clinical of research at ISP, said that the guidance will “provide a general description of the types of clinical studies carried out during the life cycle of the pharmaceutical product and describe the elements of research design supporting identification of critical quality factors to ensure the protection of participants, the integrity of data, the reliability of results, and the ability of studies to meet their objectives.”

The move is the latest harmonization effort by ISP, which in 2023 joined the International Medical Device Regulators Forum and lent its support to the idea of a multinational medicines agency for Latin America. The ISP is one of five Latin American agencies designated by the World Health Organization (WHO) as a National Regulatory Authority of Regional Reference, along with those in Brazil, Mexico, Colombia, and Cuba.

Statement (Spanish)

Chile names new top regulator

Chile’s president, Gabriel Boric, has named epidemiologist Catterina Ferreccio, MD, MPH, as director of ISP.

Ferreccio’s predecessor, Rubén Verdugo Castillo, held the post for less than a year. In October 2023 he resigned after criticism following an alert about bacterial contamination of saline products. Longtime ISP official María Judith Mora Riquelme took over his duties in the interim.

Ferreccio, who was chosen from among more than 80 candidates and whose appointment was announced by the government on 24 May, is a prominent epidemiology and public health researcher in Chile. Since 2014 she has served as deputy director for the Advanced Center for Chronic Diseases at the Pontificia Universidad Católica de Chile. Though a specialist in cancer epidemiology, she was tapped by Chile’s previous government to help shape its response to the COVID-19 pandemic, which was notable for achieving a high vaccination rate quickly. In the early 2000s, Ferreccio was the Pan-American Health Organization’s regional consultant in Washington, DC, and she earned her master’s degree in public health at Johns Hopkins University in Baltimore, MD.

Statement (Spanish)

Colombia’s INVIMA clears half its backlog, says it is hiring hundreds

Colombia’s National Institute of Drug and Food Surveillance (INVIMA) has made progress in reducing its notoriously long backlog, with about half its 27,000 stalled processes cleared in recent weeks, according to Colombian media reports citing agency officials and legislators.

In an interview with Colombia’s El Tiempo newspaper, Colombian senator David Luna, a member of an opposition coalition usually quick to find fault with the current government, praised INVIMA director Francisco Rossi in addressing the backlog, which the agency is under judicial order to resolve.

“We agreed that in 30 days we will meet again to see if they have caught up,” Luna said in an interview published 21 May, noting that while some medications shortages will likely be averted with a shorter backlog, “there [remain] 120 medications that need permanent monitoring because their quantities are limited and these are the most complex to access.” Luna described Rossi as a “serious, responsible person with valuable knowledge,” and “someone we can talk to,” he said.

In a Senate commission hearing a few days later, Rossi told legislators that the agency was in the process of hiring 200 experts to evaluate pharmaceutical applications, a permanent measure that will help avert future backlogs.

Luna said in the hearing that he assumed that many of the delayed processes – which include applications for marketing authorizations and renewals – were cleared by INVIMA simply denying the requested action.

Colombian physicians, meanwhile, have complained since April about critical shortages of anesthesia products, according to media reports, with the anesthesiologists’ society demanding that INVIMA provide a detailed accounting of the causes of the shortages, and describe any proposed measures to alleviate them.

Four Latin American agencies join WHO advanced therapies meeting

Regulators from Chile, Mexico, Argentina, and Brazil participated in a WHO meeting in Muscat, Oman, aimed at “developing a regulatory framework for human cells, tissues and advanced therapy drugs,” a category of medicines that includes gene therapies, according to press statements from WHO Oman and the different agencies.

The meeting, held 14-16 May, provided an overview of “trials, studies and exchange of experiences that allow plans for the implementation of the World Health Organization framework,” according to the Facebook page of WHO Oman, and “provided guidance to national regulatory bodies on the classification and regulation of these flagship treatments based on the new technical methods of the World Health Organization.”

Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT), in a statement following the meeting, said its participation reflects its commitment to international regulatory convergence. Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) issued a similarly worded statement. This past year Mexico has sought to position itself as a producer of biosimilar medications, both for its own health system and for export. In February, COFEPRIS published its first regulatory certainty strategy for biosimilars.

Statement

Brazil issues rules on medical gases

The Brazilian Health Regulatory Agency (ANVISA) said 22 May that it had updated its rules on medical gases classed as drugs. The new rules come into force on 1 July, ANVISA said, and companies will have 24 months to bring their products into compliance.

The rules define requirements for notification, registration and post-registration changes related to gases currently classed as medicines by ANVISA, which include medical nitrogen, oxygen, nitrous oxide and helium. Gases used in healthcare that do not qualify as medicines are outside the scope of the regulations, the agency said.

Improved registration and notification of medical gases will allow the agency to carry out detailed mapping of the production and sale of medical gases, the agency said. The rules will also aid in tracking the availability of medical gases in the health system, to help assure more consistent supplies.

The new standards were created in consultation with foreign regulatory authorities and manufacturers, the agency said.

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Latin America Roundup: Chile releases new internationally aligned clinical trials guidance

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