Latin America Roundup: Mexico formalizes regulatory reliance strategy

On 18 July, Mexico’s health ministry took a leap toward harmonization of regulatory requirements for medicines, publishing new guidelines that allow its medicines agency to honor decisions by WHO-listed regulatory authorities and permanent members of the International Council for Harmonization (ICH).
 
The guidelines cover new molecules, generic medications, biological medications, and other biological products including vaccines.
 
They also cover devices, for which decisions by the management committee member agencies of the International Medical Device Regulators Forum (IMDRF) will be recognized, as well as certifications from full member agencies in the Medical Device Single Audit Program (MDSAP).
 
Regulatory timeframes are also stipulated in the guidelines. The Federal Commission for the Protection Against Health Risks (COFEPRIS) has 45 days to issue decisions on medicines and 30 days to decide on devices.
 
These new “abbreviated” regulatory instruments, COFEPRIS said in a 21 July news release, “will allow for better and more timely access to health supplies from abroad.” The agency called regulatory reliance “an effective mechanism that promotes the simplification, updating and clarification of the regulatory framework, allowing resources to be optimized and efficiency to be increased.”
 
The measures come as part of a collaboration between COFEPRIS and Mexico’s Digital Transformation and Telecommunications Agency (ATDT) to improve regulatory efficiency and simplify procedures and are expected to take effect 30 days from their publication in the nation’s Official Gazette of the Federation.
 
The prospect of faster, simplified, reliance-based procedures could greatly ease the administrative burden on COFEPRIS. The agency is still dealing with a backlog of nearly 9,000 processes, some of them dating to 2010, according to comments made during an early July conference by Rafael Hernández Medina, the COFEPRIS commissioner in charge of authorizations, and reported in the Mexican business journal El Economista. Additionally, the agency continues to face budget shortfalls, according to a 21 July report in the same journal.
 
Statement (Spanish)
 
Mexican government invests in production of CAR-T, plasma, APIs, and vaccines
 
Mexico’s government will invest approximately USD $540 million to strengthen its domestic health products industry by way of grants to four selected companies. The investment was announced in a news conference 3 July by the country’s president, Claudia Sheinbaum, along with two key cabinet officials and representatives of the companies that will receive the funding.
 
The funds have been earmarked for specific goals, including initiating local production of chimeric antigen receptor T-cell (CAR-T) therapies; increasing the manufacture of active pharmaceutical ingredients; creating plasma-derived products in Mexico; and the production of vaccines. The four companies that will receive the funds – Kener, Genbio, Alpharma, and NeolSyM – are all Mexican-owned, with plants in Mexico.
 
David Kershenobich, the country’s health secretary, commented that the goal was to improve public access to medical products and for Mexico to achieve better national “health sovereignty,” or guaranteed supplies of locally produced medicines and vaccines. However, Kershenobich added that the program was also intended to help boost the Mexican economy and that the companies involved “will be able to export their products.” The joint public-private effort “encompasses the vision of guaranteeing the right to health, increasing [public] access to specialized treatments, and consolidating Mexico’s role as a regional hub of pharmaceutical innovation,” the health secretary added.
 
Mexico’s medicines agency, COFEPRIS, has been helping create a regulatory framework for CAR-T therapy, Kershenobich said, which, while available at some private specialty clinics and clinical research settings in Mexico, remains unregulated. The regulatory framework for CAR-T should be in place within a matter of months, Kershenobich said.
 
Video (Spanish)
 
Chilean hematologists demand regulatory action on CAR-T
 
A 14 July article in the Chilean newspaper El Mercurio detailed Chilean hematologists’ frustration with the country’s regulatory authority for not moving faster in helping them develop and test CAR-T cell therapy, a type of mmunotherapy that has shown remarkable effectiveness against certain blood cancers.
 
Regulators and specialists interviewed for the article estimated that in the best-case scenario it will be 2028 before Chile’s Public Health Institute (ISP) puts rules into place that will allow for the first clinical trials in the country. CAR-T products have thus far only been tested in animal models in Chile.
 
The researchers insisted that Chilean institutions have the capability to initiate human trials of CAR-T, but only with a regulatory framework in place. ISP officials told the newspaper that regulations are actively being explored and that they “are open to receiving requests for trials and to working with scientific institutions.”
 
Regulation of CAR-T cell therapy is especially challenging due to its potential for toxicity, the complexity of manufacturing the products, a lack of harmonized global standards, and the need for long-term follow-up. In Latin America, only Brazil has approved CAR-T therapies. Though CAR-T remains hard to access for many Brazilian patients due mainly to its cost, the country’s public research institute has pioneered low-cost CAR-T therapies that it soon hopes to make available in Brazil and beyond, according to a 16 May report in Nature Biotechnology.
 
Article (Spanish)
 
Chile, El Salvador host regulatory meetings
 
On 8 July regulators from 16 countries in the Americas met in Santiago, Chile, at a regulatory forum, Chile’s ISP said in a statement.
 
Representatives from the US Food and Drug Administration and Health Canada attended, along with regulators from Uruguay, Cuba, Brazil, El Salvador, Mexico, Peru, Nicaragua, Honduras, Panama, Colombia, Ecuador, Argentina, and Paraguay.
 
The aim was to “promote the exchange of regulatory experiences, strengthen ties of cooperation among agencies, and move toward greater regulatory harmonization for the benefit of public health in the region,” according to the ISP, which hosted the meeting. Items of constant interest in the Americas, such as the strengthening of agencies, technical exchange among authorities, regulatory reliance, and regional health resilience, were discussed, with particular attention to boosting regional pharmaceutical production as a way to avoid drug shortages.
 
Last month El Salvador’s Superintendency of Health Regulation (SRS) also hosted a reliance-themed meeting in San Salvador, with representatives of the World Health Organization and various regional regulators in attendance.
 
Statement (Spanish)