Latin America Roundup: COFEPRIS seeks to boost production of biologics in Mexico

Officials with Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) have met with local biopharmaceutical manufacturers and academics, seeking to increase national production of biological and biosimilar therapies, the vast majority of which are currently imported. The project “promises not only to transform the medical landscape, but also to strengthen the national economy,” and promote both local and regional health self-sufficiency, the agency said. COFEPRIS did not detail which entities had taken part in the meetings, or a timeframe for the project.

COFEPRIS statement (Spanish)

Mexican manufacturers resume, expand operations

Early this month COFEPRIS lifted restrictions on Psicofarma, the beleaguered Mexican manufacturer of psychiatric drugs, whose entire chain of operations – manufacturing, distribution, and sales -- was suspended by the agency in early 2023 over what it described as “grave irregularities” related to controlled substances. The suspension was controversial as it came at a time when psychiatric drugs were in short supply in Mexico. The company, which spent months working with the agency on compliance, was fined the equivalent over US $400,000. Also in August, COFEPRIS granted a license to Genomma Lab International, Mexico-based manufacturer of over-the-counter medications and personal products sold mostly in Mexico and Latin America, to extend its operations to include the fabrication of liquid medications and tablet coatings.

COFEPRIS Statement (Spanish)
Genomma Statement

Guidance aims to improve reporting on transplants in Mexico

COFEPRIS, along with Mexico’s National Transplant Center, announced new guidance on organ transplants and tissue grafts. The guidance, announced 10 August, contains 17 requirements for clinicians and transplant facilities and are intended to assure that procedures are carried out with the “fairness, altruism and transparency” mandated by Mexican law, COFEPRIS said.

The guidance relates mainly to reporting. For example, hospital donation coordinators must contact the national transplant center the moment a procedure is initiated. All transplants must be accompanied by a record “specifying precisely and completely the criteria for distributing an organ or tissue to an establishment [and] considering the ethical, medical, scientific and legal reasons for the decision, as well as its evidence.” In no case can official donation and transplant channels or reporting registries be circumvented. Clinicians engaged in the procedures may not be involved in the assignation or distribution of tissue or organs, and survival results must be registered, among other provisions outlined in the guidance.

COFEPRIS guidance (Spanish)

PAHO donates equipment to El Salvador PPE Lab

In another bid to improve regional self-sufficiency, the Pan American Health Organization (PAHO) said 14 August that it had donated equipment to a new lab, based in El Salvador under its National Medicines Directorate (DNM) set up to test personal protective equipment, or PPE. Products to be tested will include respirators, clothing, masks, scalpels, syringes, and examination and surgical gloves. The Salvadoran PPE lab will share the results of its findings with other regulatory agencies in the region, officials said, particularly those in Central America and the Caribbean, to allow for faster registration of these products.

PAHO Statement (Spanish)

Observers decry INVIMA’s lack of leadership

Colombia’s National Institute of Drug and Food Surveillance (INVIMA) has remained without a confirmed director for a year, relying on the leadership of acting directors at a time when it is increasingly under fire over delays to regulatory decisions. In an online panel hosted 8 August by the Colombian newspaper El Espectador, observers of the agency including a Colombian congressman, an oncologist, an economist and a former head of Mexico’s COFEPRIS, discussed the nature of INVIMA’s problems and potentially how to solve them. The panel was streamed via Facebook Live. No representative of INVIMA took part in the discussion despite the agency being invited.

The panelists concurred that INVIMA urgently needed a permanent director, not only to speed approvals and fix an online infrastructure prone to failures and hacking, but also if it wished to achieve the goal, supported by Colombian President Gustavo Petro, of promoting domestic and regional health sovereignty through increased domestic manufacturing of pharmaceuticals. Julio Sanchez, COFEPRIS commissioner from 2012 to 2018, commented that INVIMA must provide the technical expertise and support to develop such a “re-industrialization” strategy. Sanchez also stressed that INVIMA’s problems were not unique. Latin American regulatory and health agencies are vulnerable to major personnel changes with each new political administration, and must be made more professionalized and stable, he said.

Panel discussion (Spanish)

ANVISA announces new advisory board

Brazil’s National Health Surveillance Agency revealed 10 August that it had created a “technical chamber for the registration of medicines,” and named 10 experts who will carry out studies and issue recommendations on drugs and biological products. The experts, each of whom will serve a three-year term, comprise consumer representatives and specialists from universities, research institutes, and public and private hospitals, all with some knowledge of the regulatory process. The new panel is intended “to expand social participation in the agency’s decision making, enabling a qualified discussion with segments of civil society interested in the population’s access to medicines and biological products,” according to a report in the Brazilian news outlet Jota, which specializes in government.

Ordinance (Spanish)

Latin America Roundup: COFEPRIS seeks to boost production of biologics in Mexico

Related topics

Recommended content

Welcome to the new RAPS Digital Experience