Latin America Roundup: COFEPRIS ends emergency fast tracking for new COVID vaccines

Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) announced 22 September that new applications for COVID-19 vaccines would be subject to a period of transition to non-emergency regulatory procedures and standards, and outlined a complex series of steps for manufacturers to commercialize their newest vaccines.

One vaccine maker affected by the new rule is Pfizer. Company representatives told the Mexican press outlet Milenio that it had applied last year for emergency use authorization of its bivalent COVID vaccine co-developed with Moderna, but never received an answer from COFEPRIS. On 29 August, the company applied for emergency use authorization for its newer monovalent vaccine, which targets the Omicron XBB.1.5 variant.

After COFEPRIS’s 22 September announcement, the company reportedly applied to license its new vaccine under non-emergency rules, which stipulate that regulators may take prior approval by the U.S. Food and Drug Administration or European Medicines Agency into consideration but cannot use this information to expedite approval of a product. FDA and EMA both authorized the vaccine in September.

The issue of how new vaccines should be treated has generated controversy in Mexico, with some critics alleging that there will be two classes of COVID-19 vaccines – up-to-date products that wealthier citizens can buy on the open market, and products purchased by the government for public use, some of which may be obsolete.

The Mexican government itself appears to have a two-tiered system for dealing with vaccine products, having fast-tracked several COVID-19 vaccines of Cuban, Russian and Chinese manufacture. All vaccines previously authorized in Mexico under COVID emergency use rules will remain authorized, COFEPRIS said.

Mexico health analyst Maribel Ramirez Coronel, writing 24 September in the financial newspaper El Economista, pointed to what she called favoritism by the regulatory agency.

“With respect to COVID-19 vaccines, COFEPRIS has been rather erratic, and its decisions subject to ideological bias in which it has favored and been supremely lax with Chinese, Cuban and Russian products while placing uncertainties and extreme demands on US vaccines,” Ramirez Coronel wrote.

COFEPRIS communication (Spanish)

INVIMA eliminates renewals for medications

In an attempt to ease the regulatory backlog and assure a more constant supply of medications, Colombia’s National Institute of Food and Drug Surveillance (INVIMA) has made registrations of medical products open-ended — no longer requiring renewal processes every five years. The rule applies to both currently held licenses, which become valid indefinitely, and to new licenses.

The decree, signed 8 September by Colombia’s Minister of Health, also obliges suppliers to report any supply chain interruptions, business decisions necessitating a pause in sales, or definitive withdrawals from the local market. This is true across product classes, including drugs and biological medications as well homeopathic and natural products. Suppliers must give six months’ notice to the agency before any product can be permanently withdrawn from the market.

The changes, reported in national media outlets after the decree became public, represent the most dramatic step this year toward reducing medication shortages and a regulatory backlog that have exposed the agency to criticism. However, their implications for INVIMA’s financing, which relies heavily on licensing and renewal fees, are uncertain, and sector observers noted that no publicly known study preceded the changes, which seemed to appear almost surreptitiously.

INVIMA has issued no statements on the decree to date, though agency representatives confirmed with Colombian media outlets that the new measures are intended to relieve shortages and delays. Industry groups have remained silent.

Many sectors of the Colombian public, media, and judiciary, as well as industry groups, blame INVIMA for ongoing medication shortages, which are marked in the public and hospital sectors, and for a lack of transparency about shortages and regulatory backlogs. Adding to the concern is that the agency still lacks a confirmed director, with acting director Mariela Pardo currently at the helm.

Decree (Spanish)

Chile regulators seek more legal power to fight irregular drug sales

Officials with Chile’s Public Health Institute (ISP) are raising awareness of an increase in irregular sales of drugs in that country and seeking new resources to combat it.

In a 12 July speech to Chilean legislators, agency director Rubén Verdugo said that officials had confiscated some 473,000 units of falsified or illegally diverted medicinal products in 2022, a vast increase from previous years. Verdugo, a chemist who assumed his position in May 2023, asked lawmakers to confer increased authority for the agency to collect and act on intelligence related to falsified medicines and unauthorized sales of legitimate medications, along with increased access to tax records and other financial data to make cases.

The three most-often confiscated products by the agency are cyclobenzaprine (a muscle relaxant), losartan (an antihypertensive) and the steroid prednisone, with antibiotics and anti-anxiety medications among the top 10. Much of the unauthorized trade occurs in street markets, according to the agency.

Industry representatives have reiterated the ISP’s alarms. In a 13 September editorial in the Chilean news outlet BioBio, Elmer Torres, executive vice president of Asilfa, which represents Chilean drug manufacturers, argued for stronger penalties to combat diversion and unauthorized sales of medicines across all categories, noting that current penalties relate mainly to controlled substances. And in a 21 September news release, Claudio Pino Ponce, head of government solutions for the security consultancy SICPA, also argued that more government resources should be allotted to combat drug diversion and informal sales in Chile.

Chilean Senate report (Spanish)

PAHO and Honduran officials meet to tackle falsified medications

Representatives with the Pan American Health Organization (PAHO) met in September with regulatory officials in Honduras for workshops on preventing and detecting falsified and substandard medical products, a problem that is widespread throughout Latin America and the Caribbean.

Honduras’s Health Regulation Agency (ARSA), in collaboration with PAHO officials in the country, launched an “intersectoral working group and the planning of an action plan for the years 2023-2024,” according to government media, “establishing a solid roadmap” based on international recommendations and experience from Argentina, Colombia, Dominican Republic and Panama.

The September meetings included representatives from national police and customs agencies, universities, economic development offices, and other entities, to address key aspects of post-marketing surveillance of medicines as well as strategies to prevent and detect substandard and falsified medicines.

PAHO has had a longtime interest in combatting falsified, adulterated and substandard products, which are the bane of regulatory agencies in the region, and in 2020 published original research describing the scope of the problem. In the past, it has conducted country-specific workshops similar to the recent one in Honduras, including in the Dominican Republic in 2019. The organization appears to be reviving the initiative.

A study by ARSA, reported in government media at the time of the PAHO meeting, revealed that antibiotics, vitamins and painkillers are among the most frequently falsified or adulterated products in Honduras.

Report in GobiernoSolidario (Spanish)

Latin America Roundup: COFEPRIS ends emergency fast tracking for new COVID vaccines

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