Around the Globe

Part 1: COVID-19 Regulatory Response

Several national activities, formalized organizations, and mechanisms were highlighted in light of the world’s ongoing pandemic emergency.

The US FDA continues to support faster exchange of COVID-19 related information, ongoing participation in international initiatives to respond to the pandemic (such as creation of the Emergency Use Authorization [EUA]), and the continuous assessment and dissemination of lessons learned.

Brazil’s National Health Regulatory Agency (ANVISA) has accelerated the registration and post-approval change (PAC) review of COVID-19 pandemic related drugs and vaccines, introduced a case-by-case approach to urgent PAC and commitments, and continuous need to optimize information exchange among regulators per international standards to accelerate their decisions.

The Government of Bolivia and the Ministry of Health are currently responsible for the administration of COVID-19 vaccine free of charge. As of February 2021, Bolivia has been able to deliver priority vaccinations to first-line healthcare workers and its elderly population (age 60 and above). As part of this response, AGEMED (State Agency for Medicines and Health Technologies) implemented virtual platforms to process high volume documents at a faster pace (reducing processing time to 15-30 business days) and increased the number of personnel involved in the review of healthcare products related to COVID-19 (reducing evaluation time to 24-72 hours).

COVID-19 response in the Caribbean includes the Medicine Quality Control and Surveillance Department (MQCSD) of the Caribbean Public Health Agency (CARPHA) providing risk-based post-market surveillance, routine testing of quality of medicines submitted by the National Medicines Regulatory Agencies and Procurement Bodies, and supporting the Agency’s COVID-19 response to members of the Caribbean Community and Common Market (CARICOM).

The Institute of Public Health of Chile (ISP) introduced and issued a decree-alert implementing the country’s Central Supply of National System of Health Services (CENABAST) to handle logistics aspects of the COVID-19 vaccine distribution. As of February 2021, three COVID-19 vaccines were approved in Chile, one of which was also approved in Turkey, Indonesia, and Brazil.

The Health Regulation Agency of Honduras (ARSA), created less than four years ago with power delegated from the Public Health Ministry, implemented more than 500 online procedures through which manufacturers and importers were able to maintain access and guarantee quality, safety and efficiency of medicines circulating during the pandemic. Honduras, Mexico, and Argentina developed collaborative agreements related to vaccine manufacturing to facilitate production capacity and establish supply agreements among producers. Honduras also strengthened cooperation mechanisms with pharmaceutical companies, other regulatory authorities, academia and research institutions to improve local regulatory standards.

The challenges faced by Paraguay’s National Health Surveillance Directorate (DNVS) due to the pandemic included a shortage of qualified personnel (e.g., biologists, geneticists, and microbiologists), implementing more robust technical evaluation of pandemic-related products, and facilitating more urgent regulatory and technical information exchange with international institutions. DNVS also took immediate measures to disallow access to hydroxychloroquine and ivermectin, and introduced a more integrated IT system to take advantage of electronic communications.

The regulatory response of the Directorate General of Drug Supplies and Drugs (DIGEMID), the regulatory authority in Peru, encompassed exceptional authorization for the use, import, and manufacturing of pharmaceutical products without the need for health registration, implementation of provisions of alerts and notifications with pandemic related information for citizens, creation and dissemination of virtual applications, and providing technical and regulatory support to COVID-19 pharmaceutical manufacturers.

To streamline regulatory processes in 2020, the regulator in Argentina (National Administration of Drugs, Foods and Medical Devices [ANMAT]) implemented a remote inspection model and re-strengthened their control of clinical studies and communication plans encouraging open dialogue between the Agency and all stakeholders. ANMAT also offers expedited review of informed consent, security information and protocol change documentation, and has intensified statistical assessments and monitoring study designs to ensure accuracy of information.

In addition to these regulators from the Americas, a representative of the European Medicines Agency (EMA) presented the Agency’s global convergence efforts, with a focus on the work of the International Coalition of Medicines Regulatory Authority (ICMRA), a voluntary group of the Heads of Agencies (co-chaired by EMA and FDA) who gather to discuss common challenges, solutions, issues, digitalization, and remote inspections, while trying to promote convergence of science and information exchange through multiple resources. COVID-19 resources promoted by ICMRA include Strategic Meetings where global regulators work toward aligning policy approaches and regulatory flexibility, and Workshops about COVID-19 virus variants, pregnancy and lactation, observational studies and real-world data, and vaccine safety collaboration.

References available upon request.