To perform optimal monitoring of the safety profile in the postmarketing phase, Marketing Authorization Holders and National Regulatory Authorities (NRAs) must evaluate the adverse drug reactions (ADRs) that occurred and characterize their nature, frequency, and severity. Management is possible through Individual Case Safety Reports (ICSRs), which are the reports of organized and processed data. Globally, the International Council for Harmonisation (ICH) E2B guideline suggests harmonized activities for the ICSR electronic content and transmission. In America, the Pan American Health Organization (PAHO) is the agency responsible to implement cooperation among its members, which are recognized as National Regulatory Authorities of Reference (NRARs) such as Argentina, Brazil, Canada, Chile, Colombia, Cuba, Mexico, and the United States. PAHO published the 'Good Pharmacovigilance Practices for the Americas' suggesting improvement and harmonization in the region. After reviewing the regulatory framework, it is assumed that all NRARs have a regulated ICSR transmission system (i.e. a systematic vigilance system for collecting, analyzing, and disseminating information from ADRs). However, significant differences exist, such as the requirement for social media vigilance, expedited and non-expedited ICSRs, coding, severity, and transmission. The volume of ICSRs has significantly increased, due to using electronic standards managed by the NRAs, which facilitates early identification of new ADRs, allowing the implementation of novel minimization activities, contributing to the continuous assessment of the benefit-risk balance of medicines. Nevertheless, there is still area for improvement, especially in Latin America.
Keywords: Individual Case Safety Report; National Regulatory Authorities of Reference; National Regulatory Authority; adverse drug reaction; harmonization.
Transmission of spontaneous adverse drug reactions by industry in countries designated as a reference by the Pan American Health Organization (PAHO): comparison on regulatory requirements This review aims to describe regulatory criteria and compare harmonization across regions that marketing authorization holders must fulfill when transmitting spontaneous adverse drug reactions to the authorities for postmarketing surveillance. It centers on the regulatory requirements of authorities designated as a reference by the PAHO. Consequently, it is important to review the regulatory framework, to evaluate the requirements for transmission and have the context of the current harmonization among these agencies in America. This review contains the minimum criteria for transmission and harmonized guidelines according to the International Council for Harmonisation (ICH) and PAHO. However, identifying the differences is only the first step, future research in harmonization must continue to advance the understanding and establish guidelines that allow a better evaluation of the safety profile of medical products.
© The Author(s), 2024.