Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation
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 thro...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2024-02-01
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| Series: | Therapeutic Advances in Drug Safety |
| Online Access: | https://doi.org/10.1177/20420986241228119 |
| _version_ | 1797324064247775232 |
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| author | Antonio Lomeli-Silva Homero Contreras-Salinas Mayra Yolanda Barajas-Virgen Maria Soledad Romero-Lopez Lourdes Yolotzin Rodríguez-Herrera |
| author_facet | Antonio Lomeli-Silva Homero Contreras-Salinas Mayra Yolanda Barajas-Virgen Maria Soledad Romero-Lopez Lourdes Yolotzin Rodríguez-Herrera |
| author_sort | Antonio Lomeli-Silva |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T05:44:52Z |
| format | Article |
| id | doaj.art-860b0c1ce2494ed0bc97c65758525f1e |
| institution | Directory Open Access Journal |
| issn | 2042-0994 |
| language | English |
| last_indexed | 2024-03-08T05:44:52Z |
| publishDate | 2024-02-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Drug Safety |
| spelling | doaj.art-860b0c1ce2494ed0bc97c65758525f1e2024-02-05T14:04:37ZengSAGE PublishingTherapeutic Advances in Drug Safety2042-09942024-02-011510.1177/20420986241228119Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulationAntonio Lomeli-SilvaHomero Contreras-SalinasMayra Yolanda Barajas-VirgenMaria Soledad Romero-LopezLourdes Yolotzin Rodríguez-HerreraTo 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.https://doi.org/10.1177/20420986241228119 |
| spellingShingle | Antonio Lomeli-Silva Homero Contreras-Salinas Mayra Yolanda Barajas-Virgen Maria Soledad Romero-Lopez Lourdes Yolotzin Rodríguez-Herrera Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation Therapeutic Advances in Drug Safety |
| title | Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation |
| title_full | Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation |
| title_fullStr | Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation |
| title_full_unstemmed | Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation |
| title_short | Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation |
| title_sort | harmonization of individual case safety reports transmission requirements among paho reference authorities a review of their current regulation |
| url | https://doi.org/10.1177/20420986241228119 |
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