Latin America Roundup: Agencies continue shift to online processes

Agencies across Latin America and the Caribbean have announced or are taking steps to streamline regulatory processes for pharmaceutical products in 2025.

On 21 January, the Brazilian Health Regulatory Agency (ANVISA) will implement a resolution, published in December, that simplifies processes for makers of generic drugs, radiopharmaceuticals, and biological products, including vaccines and biosimilars.

To use the simplified process, a company or its affiliates must hold at least one valid marketing authorization for a drug or biological product in Brazil. Each application must reference a product currently authorized in Brazil and listed as a reference medication by ANVISA. Products originating from a product development partnership or drug technology transfer process are also eligible.

Simplified processes can also be used for withdrawals of marketing authorizations, correction of data, new indications, package inserts, trade name changes, and transfers of ownership, among other applications. The simplified processes will be initiated and handled digitally, in accordance with the agency’s ongoing efforts toward full digitalization.

In Colombia, the National Institute of Food and Drug Surveillance (INVIMA) announced that it was readying “a package of measures” intended to substantially reduce wait times for marketing authorizations and renewals. This includes a transition to largely online services through which users may be able to follow processes in real time, INVIMA said in a 23 December statement, and which will reduce opportunities for corruption by cutting out intermediaries.

The Dominican Republic’s General Directorate of Medicines, Food and Health Products (DIGEMAPS), which has in recent years prioritized faster approvals, digitalization, and harmonization, says its streamlining efforts are working – and that it issued more than 3,000 marketing authorizations for medicines in 2024, according to an official statement 8 January. The pace is expected to continue through 2025, the agency said.

The agency’s “institutional strengthening strategies, digitalization of processes and alignment with global standards,” together mark a “before and after in the national regulatory landscape,” DIGEMAPS officials said, and have helped position the Dominican Republic as “a regional benchmark” for regulation. In October 2024, DIGEMAPS became an affiliate member of the International Medical Device Regulators Forum.

Honduran regulators say they, too, are working to increase the pace and quantity of approvals in 2025. In a statement issued 4 January, Dorian Salinas, head of Honduras’s Health Regulation Agency (ARSA), said an effort was underway to boost public access to medicines by increasing the number of approvals, not just for generic drugs but also for advanced therapies and innovative therapies.

ANVISA Resolution (Portuguese)

Brazil approves priority agency list for reliance

ANVISA on 23 December published a list of national regulatory agencies that will be prioritized, the agency said, as part of its reliance strategy for the assessment of devices and medicines and described how each fits into that strategy. The listed agencies comprised those of Egypt, Mexico, Thailand, Peru, the UK, Colombia, Chile, and Australia.

ANVISA will look to Mexico on drug registrations and good manufacturing practice compliance inspections for both drug and device manufacturers, ANVISA said. The Thai and Egyptian agencies will be references for device registrations. The Colombian and Chilean agencies will be references for drug registrations and drug GMP compliance. Peru’s agency will be a reference for drug GMP compliance. The UK and Australia will be references for device registrations.

In an accompanying statement, ANVISA said the reliance initiative is intended to be in part reciprocal and that the agency hopes to have 70% of the listed priority agencies adopt reliance practices that use ANVISA’s decisions by 2029. “This strategy is essential for the recognition of ANVISA as an international reference health authority,” the agency said.

Statement (Portuguese)

ANVISA opens public consult on sanctions

Through 3 February, ANVISA is soliciting public comment on new rules that would change how drug and device companies are sanctioned following findings of infractions resulting in health risks or damage to health. The proposed rule changes, according to an analysis by the Brazilian law firm Licks Attorneys, stem from a 2020 government audit that found the agency to be inefficient in investigating infractions and imposing penalties.

Licks Attorneys wrote that the proposed rule is “based on the implementation of a responsive surveillance model” that takes into consideration “the potential health risks associated with the infraction; the compliance history of the company; and the need to prevent or mitigate identified risks more quickly.” Under this model, companies would be encouraged to voluntarily comply with regulatory requirements “as an alternative to a regulatory model that is strictly based on punishments.”

The new model also contains provisions for multiplying penalties for concurrent infractions resulting from the same case, or for a “continuous infraction.” These provisions, the Licks attorneys warned, “could represent an excessive burden, for example, to the medical devices industry … should ANVISA continue to fine these companies for each issued notification, despite recognizing voluntary recall actions as a mitigating circumstance.”

Proposed rule (Portuguese)

Argentina harmonizes plant inspection rules with neighboring countries

On 26 December, Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) published a new rule updating standards and procedures for inspections of device and in vitro diagnostic product manufacturers. The rule harmonizes ANMAT’s standards with those recently adopted by the Mercorsur common market countries, a group that includes Argentina, Brazil, Paraguay, and Uruguay.

Rule (Spanish)

Colombian industry group chooses new president

AFIDRO, a group representing international pharmaceutical companies active in Colombia, announced on 19 December that it had named Ignacio Gaitán as its new president. Gaitán, an attorney who has represented different businesses in Colombia including, most recently, a large media group, will replace María Clara Escobar, who has held the post since 2022.

Statement (Spanish)

Latin America Roundup: Agencies continue shift to online processes

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