Latin America Roundup: Brazil, Mexico lay out regulatory priorities

The Brazilian Health Regulatory Agency (ANVISA) has published its priorities for the next three years. In its most recent strategic plan, covering 2024-2027, the agency says it will seek recognition from the World Health Organization (WHO) as a WHO-listed Authority, in part to facilitate Brazilian manufacturers’ access to other markets.

ANVISA also said it seeks to adopt of the Identification of Medicinal Products (IDMP) standard, to continue its efforts for medical device Unique Device Identification (UDI); and modernize its data platforms, among other stated goals, several of which have been carried over from its 2020-2023 strategic plan.

Specific objectives described in the new plan include facilitating commercialization of biological agents within two years of marketing approval and increasing the number of Brazil-developed biosimilar medicines or innovative drugs by 20%.

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) also recently made public its priorities and work agenda for 2024, some of which parallel those laid out by ANVISA.

In a document released on 30 January, COFEPRIS described efforts to promote regulatory certainty, improve confidence in its processes, and expand digitalization as a strategy to speed approvals.

COFEPRIS said 2024 would see the launch of its biosimilars unit and pharmaceutical development committee, both of which share the goal of expanding Mexican manufacturing. The agency also promised to refine rules for conducting clinical research “with the aim of achieving competitive service times.”

In the medical device space, the agency stated its aim to further align its good manufacturing practice (GMP) requirements with international standards; seek integration into the Medical Device Single Audit Program; and to eliminate obstacles to international trade due to differences in labeling. In December, COFEPRIS drew notice to its newest detailed guides on registering devices and medicines in Mexico.

ANVISA (Portuguese), COFEPRIS (Spanish)

COFEPRIS says it fired 43 employees for corruption

In a communication issued 28 January, COFEPRIS declared itself to be “an institution free of corruption” and outlined specific measures it had taken to end corrupt practices.

The agency said that it had fired 43 people – among them top administrators – “for alleged participation in practices to favor particular interests” and complicity with regulated industries, among other illicit activities. The agency did not say whether the dismissed individuals had been charged with crimes or detail in what time period the dismissals had occurred, saying only that they had been carried out under a “zero impunity” policy and making reference to activities under previous governments.

COFEPRIS also stated that it had banned the participation of intermediaries or brokers in its processes, pointing to its digitalization strategies as a key factor in reducing corruption. It made note of its intelligence-sharing agreement with the Mexican Navy to track psychotropic substances and precursor chemicals, and disclosed its use, in conjunction with state health authorities, of more than 1,000 video cameras to monitor employee activity. The video monitoring exists both to prevent unjust accusations against regulatory professionals and to assure that “attention, procedures and verifications will be free of discretionary acts,” the agency said.

COFEPRIS (Spanish)

Colombia’s INVIMA seeks path out of crisis; country’s pharmacists plead for new director

Colombia’s National Institute of Drug and Food Surveillance (INVIMA), facing criticism for its lack of a confirmed director, shortages of critical drugs, and backlog of registrations and renewals, has taken some measures to attempt to wrest control of a situation widely described as a crisis.

In a decree issued in January, and republished by the healthcare industry news outlet Consultorsalud, INVIMA acting director Yenny Adriana Pereira Oviedo described new, temporary provisions allowing drug manufacturers in Colombia to more easily attain on-site compliance evaluations to support new registrations, with priority given to manufacturers of products vulnerable to shortages.

In a different document, reproduced in the news outlet InfoBae, Pereira Oviedo laid out changes to the legal requirements for a new permanent director of INVIMA, following the withdrawal of former World Health Organization (WHO) veteran Germán Velásquez early this year. The changes include allowing for the consideration of a candidate with a humanities background. Part of the reason for the holdup in Velásquez’s confirmation was reportedly because he held degrees in economics and philosophy rather than medicine or pharmacy.

On 24 January, two pharmacists’ associations in Colombia sent an open letter to Colombian President Gustavo Petro demanding that he name a permanent director for INVIMA, “Given that this entity is of the greatest importance to the national aims of advancing health autonomy, improving the dynamics of pharmaceutical supply and effectively assuring that health technologies … are safe, effective and of optimal quality.” The presidents of Colombia’s National College of Pharmaceutical Chemists (CNQFC) and Colombian Association of Pharmacy Programs (ASCOLPROFAR) signed the letter, published in Consultorsalud, which urged the president to consider a candidate committed to health self-sufficiency, more robust local production of medicines, and the elimination of barriers to health technologies for the Colombian population.

INVIMA (Spanish)

Honduras imports thousands of HIV self-tests; Mexico authorizes first HIV self-test

Honduras’s Health Regulation Agency (ARSA) announced on 30 January that it had facilitated the importation of more than 2,000 HIV self-test kits from South Africa in what it described as “a significant advance” to promote detection and treatment. Mexico’s COFEPRIS agency, meanwhile, on 31 January announced its first-ever marketing approval of an HIV home test.

ARSA (Spanish)

Ecuador issues alert on falsified emergency contraceptives

On 29 January, regulators with Ecuador’s National Agency of Health Regulation, Control and Surveillance (ARSCA) issued a public alert about a falsified lot of an emergency contraceptive.

The alert concerned a single numbered lot of a 1.5 mg preparation of levonorgestrel branded as Glanique 1 and licensed in Ecuador by the laboratory Medicamenta. The lot in question was not imported by its license holder and was reported to regulators by the company, which conducted tests after noticing discrepancies in its packaging. The falsified product turned out to contain only acetaminophen.

While adulterated or falsified medicines are ubiquitous across Latin America and the bane of the region’s regulatory agencies, contraceptives are of particular concern as many of the same countries outlaw abortion. In 2021, substandard contraceptive pills were distributed at public clinics in Chile, with some 140 unplanned pregnancies reported to have resulted.

ARSCA (Spanish)

Latin America Roundup: Brazil, Mexico lay out regulatory priorities

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