Around the Globe

Part 2: Regional Tour: Regulatory Updates
Beyond the response from regulators to the health emergency, there are several other important updates to report from the regional regulatory agencies in Latin America.

Brazil’s ANVISA has organized its 2020-2022 Strategic Plan into principles, objectives, and initiatives that will guide the transformation of government through digital technologies in Brazil. This transformation will also deliver efficiency gains for public management, issuance of the International Certificate of Vaccination and Prophylaxis, an established digital trajectory for both the government and the economy, and strategic alignment between government actions and other measures to stimulate an increasingly digitized, dynamic, productive, and competitive Brazilian economy.

In addition to its COVID-19 response mentioned above, the main 2021 goals for CARPHA include implementing a risk-based post-market surveillance program to ensure the quality, safety, and efficacy of selected medicines in the Caribbean, routine testing of medicines submitted by the National Medicines Regulatory Agencies and Procurement bodies, continued maintenance of the ISO/IEC 17025 accreditation, and providing training support to the National Quality Control Laboratory of Jamaica.

Ecuador’s regulator (National Agency for Regulation, Control and Sanitary Surveillance [ARCSA]) issued a resolution that rendered their technical health regulations mandatory to ensure traceability control of imported and national medicines, biological products, and medical devices marketed and registered within Ecuador. In addition to this National System of Traceability, the Agency is preparing to launch a mobile data matrix system app for traceability of each drug. Ecuador also has introduced new cannabis regulations.

FDA’s Latin American Office (LAO) covers 44 nations and territories including Mexico, Central America, Caribbean, and South America, and conducts its activities from three offices, in San Jose (Costa Rica), Mexico City, and Santiago (Chile). LAO’s current activities include outreach across all stakeholders to promote better understanding and support of regulatory convergence in initiatives with other regulators such as the National Regulatory Authorities of Regional Reference (NRAr), the Pan American Network for Drug Regulatory Harmonization (PANDRH), Latin American academic organizations, and regional pharmaceutical and medical device industries to promote regulatory modernization and convergence in Argentina, Brazil, Canada, Chile, Colombia, Cuba, and Mexico. LAO also engages in initiatives of regulatory convergence for medical devices, pharmaceuticals, and biologics at a global scale through International Medical Device Regulatory Forum (IMDRF) and Medical Device Single Audit Program (MDSAP). The LAO Newsletter for regulators is just one of several resources for the most accurate updates about the pandemic and these bilateral collaborations.

Since 2017, Honduras’ ARSA has approved more than 25 new regulatory guidelines for the supervision, review, verification, control, surveillance, and audit of the legal, technical and administrative compliance of establishments and health products. Honduras has also invested in developing a strong pharmacovigilance capability through an agreement to develop regional interventions to enable access and to guarantee quality, safety, and efficacy of medicines that circulate in the central American region from 2018-2021 signed by the National Center for Pharmacovigilance with the Executive Secretariat of the Council of Ministers of Health of Central America and the Dominican Republic (SE-COMISCA).

The Directorate General of Drug Supplies and Drugs (DIGEMID), the regulatory authority in Peru, and Paraguay’s National Health Surveillance Directorate (DNVS), shared their experience with similar challenges in developing and implementing specific regulations and guidelines, and capacity building in the context of limited financial and human resources. DNVS’s petition to become a fully independent regulatory institution has been presented to the Paraguayan Congress, and there is expectation that this proposal progresses in 2021.

References available upon request.