Latin America Roundup: Mexico, PAHO seek to help Guatemala boost regulatory capacity
In the latest binational effort toward regulatory convergence in Latin America, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) announced on 2 May a plan to work with regulators in Guatemala to promote “innovative regulation based on cooperation,” the agency said in a news release.Representatives with Guatemala’s Department for the Regulation, Accreditation, and Control of Health Facilities (DRACES) met with Mexican regulators in April to begin laying out a formal collaboration agreement, according to COFEPRIS. Representatives of the Pan-American Health Organization (PAHO) also participated.
The agencies agreed to personnel exchanges in their national laboratories of reference and proposed cross-border surveillance initiatives. COFEPRIS invited Guatemalan regulators to take part in its nascent regulatory school and has pledged to provide the Guatemalan agency with a quality management system.
COFEPRIS noted in the release that Mexico’s national regulatory system is designated a level 4 by the World Health Organization, meaning that it operates at an advanced level of performance with continuous improvement. Mexico seeks to support Guatemala’s goal to achieve Level 3 status – indicating a stable and well-functioning system -- by 2030, according to the release.
COFEPRIS (Spanish)
Mexico meets with makers of controlled pharmaceuticals
COFEPRIS convened representatives from both national and international pharmaceutical manufacturers to help clarify expectations and address technical concerns related to controlled substances, the agency said in an 8 May statement.
The agency’s outreach to industry comes less than a year after its sanctions on Psicofarma, Mexico’s largest producer of psychiatric medications, were finally lifted. COFEPRIS ordered operations at Psicofarma to be suspended in early 2023 over irregularities related to controlled drugs. Only last August, after prolonged negotiations, did manufacturing resume. COFEPRIS was criticized at the time for having exacerbated a national shortage of psychiatric drugs, and the agency has since sought to avert actions that could affect supplies.
The recent meeting, COFEPRIS said, “marks the continuation of work toward proactive regulation, with the aim of establishing a regulatory path that promotes advances in access to controlled medicines that are safe, effective and of high quality. This process seeks to provide transparent support to the companies involved.”
COFEPRIS (Spanish)
Colombia, PAHO announce technical accord
Colombia’s National Institute of Drug and Food Surveillance (INVIMA) said on 8 May that it had signed a technical cooperation agreement with the PAHO to strengthen the country’s regulatory capacity for food, medicines, and medical devices with the aim of improving Colombia’s health sovereignty and that of the region.
INVIMA director Francisco Rossi, who was appointed to the role earlier this year, has sought to re-envision its mandate as a key promoter of health sovereignty for Colombia and Latin America, rather than a strictly technical body.
The five-year agreement, according to INVIMA, includes support for technical and scientific cooperation; the development of scientific, technical and regulatory information exchange programs; strengthening the inspection, surveillance and control capabilities of INVIMA; and forging strategic alliances with other regional authorities.
INVIMA (Spanish)
Brazil to recognize foreign agencies’ GMP audit reports, with caveats
Brazil’s National Health Surveillance Agency (ANVISA) says that it will recognize good manufacturing practice (GMP) audit reports for active pharmaceutical ingredients, medical cannabis products, medicines, and biological products from national regulatory agencies in 42 countries worldwide. However, not all agencies’ reports are given the same weight under the new scheme.
The goal of the rule change, ANVISA said in a statement on 3 May, is to “accelerate the analysis of [GMP] certification applications submitted to the agency, without giving up the technical rigor necessary to establish compliance with the GMP.”
The rule, which comes into effect in June, specifies that ANVISA can consider GMP audit reports by foreign regulatory agencies that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the International Council for the Harmonization of Technical Requirements of Medicines for Human Use (ICH). Most of the listed agencies are in Europe, North America and Asia, with Mexico’s COFEPRIS the sole Latin American agency named.
ANVISA said it would employ different levels of confidence when evaluating foreign GMP reports. Reports from an authority of “partial” confidence will require ANVISA to conduct a full analysis before granting GMP certification in Brazil, whereas a report from an entity of “complete” confidence requires only a simplified analysis. In cases of “mutual recognition,” no further analysis is required. Mutual recognition can occur only in the context of a bilateral agreement or established regulatory reliance program between ANVISA and the foreign agency, ANVISA said.
ANVISA (Portuguese)
Canada and Brazil advance cooperation initiatives
Brazil’s ANVISA agency has signed an agreement with Health Canada “to strengthen the exchange of technical information and inspection reports on practical manufacturing practices for medicines, biological products, active pharmaceutical ingredients and medical devices,” ANVISA said in a brief statement on 2 May.
The agreement “will allow the advancement of ANVISA’s bilateral relationship with the Canadian authorities and will facilitate the establishment of eventual regulatory trust mechanisms,” ANVISA said.
ANVISA (Portuguese)
ANVISA opens public comment period on drug trials
Following recent, multifaceted efforts to align itself with international regulatory norms, Brazil’s ANVISA said on 30 April that it has opened a public consultation on changes to how it regulates clinical trials.
The 45-day comment period comes as part of a review of current rules, in place since 2015, governing drug trials designed to support new registrations of medicines. The agency aims to create updated rules that “adequately address the stages of innovation and guarantee the harmonization of Brazilian regulation with international standards,” ANVISA said in a news release.
ANVISA (Portuguese)
