Latin America Roundup: COFEPRIS updates GMP guidelines, beefs up new molecules committee

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) has issued Good Manufacturing Practice (GMP) guidelines aimed at “facilitating the recognition of international regulations and reducing administrative barriers” for the pharmaceutical industry, according to the agency.

Under the new guidelines, issued 20 March, Mexico will accept GMP certifications issued by regulatory agencies in Brazil, Argentina, Canada, Colombia, Chile, Cuba and the US. The new guidelines also implement the full digitization of processes, align with the international Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the United States-Mexico-Canada Agreement (USMCA); and recognize international standards from WHO as well as ISO 13485:2016 certification for medical devices.

GMP certifications issued by COFEPRIS will be valid for 30 months, the agency said, with extensions of up to 15 months.

The Mexican agency also reported that it had strengthened the expertise of its new molecules committee, which is key to approvals of novel pharmaceutical agents, by integrating experts from another body under the authority of its health secretariat, the Coordinating Commission of National Health Institutes and High Specialty Hospitals (CCINSHAE). The inclusion of this group of specialists, COFEPRIS Commissioner Armida Zúñiga Estrada said in a 14 March statement, “Will significantly contribute to evidence-based decision-making with the highest scientific rigor. Furthermore, the work they will perform will directly impact the availability of innovative treatments.”

Zúñiga Estrada, who has helmed the agency since October 2024, has sought to better coordinate COFEPRIS’s work with that of other government bodies. Earlier this month the agency struck an agreement with Mexico’s patent office establishing mechanisms that would allow more marketing authorizations to move forward without violating patent claims, as a way to improve public access to low-cost generics.

The agency has also worked to speed approval times for most processes, though much remains to be done. In recent weeks state legislators in Mexico have clamored for a reduction of approval times for imported stem cell therapies needed to treat leukemia and other diseases, according to Mexican media reports, demanding that COFEPRIS slash wait times from 45 days to 10.

Statement (Spanish)

Paraguay, PAHO laud drug pricing change

Regulators with Paraguay’s National Directorate of Health Surveillance (DINAVISA), and the Pan-American Health Organization (PAHO) are reporting success with a new international reference pricing scheme for medicines.

The scheme, adopted in November 2024, was designed to make medicines more affordable. Prices of certain drugs, including oncology therapies, have dropped substantially since its implementation, according to a 28 February statement by PAHO, which lent technical support to the DINAVISA effort.

Paraguay had previously used a pricing system based on markup limits (maximum markup percentages), one of several ways to improve medicines access that is recognized by the World Health Organization. Setting lower mark‑up limits for higher‑priced medicines can encourage the use of lower‑priced medicines and generics, according to WHO.

International reference pricing, which is already used in Colombia and Brazil, allows regulators to set prices based on the standards of comparable countries in terms of region, market size, currency strength and other factors. Prices are compared at a common point or points in the production and distribution chain. In Paraguay’s case, seven countries are being used as references. The Regional Observatory for Medicine Prices, run by United Nations Office for Project Services (UNOPS), collects country-specific price data for drugs that regulators can consult.

On 13 March, the Brazilian business news outlet Valor International reported that the Brazilian Health Regulatory Agency (ANVISA), which already uses a type of international reference pricing among its price-control strategies, is exploring changes to how it uses such references for high-cost, innovative medications that strain public health budgets and for which the first or only pricing reference may be the United States, where drug prices are not regulated.

“The idea is to establish an initial price until the drug is available in a greater number of countries, allowing for a more accurate global price benchmark,” according to the report. Brazil’s ongoing review of drug pricing regulations was “driven … by lawsuits demanding that the government cover costly treatments” such as Novartis’ Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy in children.”

After 2020, when Zolgensma was approved in Brazil, Brazilian courts repeatedly obliged the health system to pay for it at $1.7 million per treatment, which was closer to the US list price of $2.1 million than the $530,000 ANVISA had deemed the appropriate price for Brazil, but which the manufacturer rejected. Two years and tens of millions of dollars in payments later, a price of $1.1 million was agreed.

PAHO Statement

Uruguay editorials prod government on medicines agency

In Uruguay, whose new presidential administration took office this month, a series of editorials in the news outlet La Diaria has urged health officials to act decisively to create a discrete medicines agency, which the country currently lacks. In Uruguay, regulatory functions are carried out by the Ministry of Public Health (MSP).

Citing new health minster Cristina Lustemberg’s promise earlier this year that she would seek to create a regulatory agency, Ruben Cano, a pharmacologist with Uruguay’s University of the Republic, and Raul Labadía, a public policy expert with the ruling political party, argued that the regulatory agencies of Argentina, Chile and Brazil should serve as Uruguay’s model – and that the work to build one needed to start now.

In three separate editorials published in in January, February, and March, Cano and Labadía laid out a detailed case for a semi-autonomous, financially independent agency with high technical expertise, and described all of its proposed responsibilities. They argued that Uruguay had missed out on the kinds of opportunities that its neighboring countries had created through their medicines agencies, all of which are now recognized by WHO as national regulatory authorities of regional reference.

“Uruguay chose to remain outside this innovative trend” to the detriment of the country’s pharmaceutical sector, they wrote. “Production for export, research and development, clinical research, and other higher value-added activities, such as the local production of more biotechnological medicines, are seriously affected.”

While Uruguay’s new government is under “severe financial restrictions,” the writers acknowledged, and “the creation of a drug regulatory agency may not be among its investment priorities … we believe that its pro-growth agenda will unequivocally demand it if it intends to revitalize the pharmaceutical industry and improve the health policies it implements.”

La Diaria (Spanish)

ANMAT updates biosimilars guidance

Argentina’s National Administration of Foods, Drugs and Medical Devices (ANMAT) has published new guidance for biosimilars. The guidance, issued 14 March, updates on comparative efficacy for biosimilar products, conditions that reference products must meet. It addresses nonclinical studies, in vitro and in vivo studies, pharmacokinetics, pharmacodynamics, confirmatory PK/PD studies, and immunogenicity, among other areas. Therapeutic products obtained from living organisms or cells, and include therapeutic peptides and proteins derived from recombinant DNA technology, are covered by the guidance, as well as low molecular weight heparins and recombinant analogues of plasma-derived products. Vaccines are outside its scope.

Statement (Spanish)

Latin America Roundup: COFEPRIS updates GMP guidelines, beefs up new molecules committee

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