Latin America Roundup: Brazil to recognize other agencies’ decisions on devices

Correction: A previous version of this story incorrectly listed the European Union in the list of jurisdictions ANVISA has proposed to recognize for certain medical device registration deicisons.

In a step toward consolidating regulatory reliance, The Brazil Health Regulatory Agency (ANVISA) said on 8 April that it would recognize decisions by regulators in Australia, Canada, Japan, and the United States to register certain medical devices. The policy, which takes effect on 3 June, will shorten analysis times and lead to faster registrations, ANVISA said. Applicants must demonstrate that any product destined for the Brazilian market has “the same production characteristics, indications and intended use” as a product submitted to the foreign regulatory agency whose decision will be referenced.
 
In recent years ANVISA, one of the founding members of the International Medical Device Regulators Forum (IMDRF), has been updating its device rules and working toward greater alignment with other major global agencies. The new device reliance measures come after a public consultation process opened by ANVISA last fall on the use of analyses by the same foreign authorities. While ANVISA did not say in its 8 April statement which device classes would be covered by the new rule, the public consultation covered risk classes 3 and 4 as well as in vitro diagnostic devices.
 
The agency said it will soon hold an online seminar with interested companies to share information related to the policy.
 
ANVISA (Portuguese)
 
ANVISA meets with Portuguese regulators on reliance initiatives
 
Top regulators with ANVISA met with their Portuguese counterparts this month for discussions on possible reliance initiatives. The meeting, which took place 10 and 11 April in the city of Coimbra, Portugal, and addressed “the actions of health authorities in both countries, in the search for regulatory convergence in the area of medicines, including biosimilars, clinical research, innovation, regulatory trust (reliance) and prices,” ANVISA said. Reliance, the agency noted, “has been a topic of discussion among health authorities around the world, especially in a post-pandemic reality, which calls on countries to interact in the search for shared solutions to common regulatory issues.”
 
While this meeting represented the first to discuss specific categories of reliance initiatives, ANVISA has worked with Portugal’s National Authority of Medicines and Health Products (INFARMED) for two decades, establishing the first technical and training exchanges in 2004.
 
In January of this year, INFARMED hosted a meeting in Lisbon for regulators across the Portuguese-speaking world, which included regulators from Brazil, Cape Verde, Mozambique, Angola, and East Timor, among other countries, with the aim to strengthen cooperation.
 
ANVISA (Portuguese)
 
Brazil approves national packaging and formulation of insulin glargine
 
On 4 April, ANVISA approved a series of post-registration changes that will allow insulin glargine to be formulated and packaged in Brazil, the agency said.
 
While Brazil was previously home to one of the world’s major insulin manufacturers, and has more than 6 million people requiring insulin treatment, all of its insulin products are currently imported. The ANVISA decision allows for a previously registered Chinese-made product to be formulated and packaged in a factory owned by the Brazilian company Biomm.
 
ANVISA described the move as “an important milestone for Brazil with regard to the return of national insulin production, even if at this moment it is only for the formulation and packaging stages.” Brazilian newspaper O Tempo reported that the new Biomm facility, in the state of Minas Gerais, has the capability to meet 80% of national demand for insulin packaging.
 
ANVISA (Portuguese)
 
Argentina launches new pharmacovigilance platform for industry
 
Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) gave notice on 4 April of a decree establishing a new online reporting platform for pharmacovigilance. The “eReporting Industria” (eReporting Industry) platform will be, according to ANMAT, a single system for companies holding marketing authorizations of products to report to the agency’s pharmacovigilance division. Reports related to adverse reactions, medication errors, lack of efficacy and pregnancy exposures will all be covered under this system. The reporting requirements will be published in a separate manual, the agency said, and marketing authorization holders must register with the system at least 45 days before sending reports. Only companies are affected by the new system; existing pharmacovigilance reporting channels for patients and healthcare providers will continue to be used. ANMAT has yet to issue a detailed news release concerning the platform, its implementation, or when the manual can be expected.
 
ANMAT decree (Spanish)
 
Regional school for regulators gets push at Cuba meeting
 
Regulators from Mexico, Colombia, Cuba and Brazil met to discuss and promote the Regional Health Regulation School (ERRS), a cornerstone of recent efforts to unite regulatory agencies in Latin America.
 
At the BioHabana 2024 meeting, which took place the first week of April in Havana, Cuba, representatives from the different agencies -- including Francisco Rossi, head of Colombia’s National Institute for Food and Drug Surveillance (INVIMA) and Alejandro Svarch, head of Mexico’s COFEPRIS -- were joined by officials with the Pan-American Health Organization, which along with the European Union has backed the regional effort.
 
The proposed school seeks to train regulators from different countries in technical aspects of regulation, but also to promote a regulatory approach tailored to regional needs, one that can help member countries achieve more equity in access to medicines. The meeting, according to a COFEPRIS news release, “highlighted the importance of three basic functions that States must assume in relation to health supplies: regulate to promote equitable access; provide safe, effective and quality supplies, and provide information to reduce asymmetries in knowledge about drugs.”
 
In addition to training regulators, the school will also train representatives of economic integration organizations, consumer groups, academics, and other stakeholders across Central America, South America, and Caribbean countries, COFEPRIS said in its statement.
 
According to a news report in the Cuban outlet Cubadebate, INVIMA’s Rossi told the conference that because the region’s regulatory agencies were modeled after those of developed countries, the actions required to respond to regional needs are not well addressed in current training programs for regulators, and therefore a new model is needed.   
 
The broader goal of the inter-agency effort, Rossi said, “Is to transform the use of medicines. Regulatory agencies are a bit closed in their processes and we need more openness, so that this information reaches doctors and society.”
 
COFEPRIS (Spanish)