This paper introduces some comments on the complete text of Good Pharmacovigilance Publishing Practices, which forms appendix number 2 of the Good Pharmacovigilance Practices now published by the French Drug Agency, as was Good Clinical Practices. Each good practice is printed in italic and presented in a frame; the following comments are designed to facilitate its application. The technical terms that are used in this text are presented according to the glossary in Good Pharmacovigilance Practices.
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Rev Med Chil
November 2024
Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
In the prevailing medical pluralism of contemporary society, alternative and complementary medicine occupy a relevant place, comprising a heterogeneous group of practices with different values depending on tradition and social acceptance. Their scarce regulation and growing use, facilitated by promotion through social networks and distrust of the dominant biomedical model, have generated interest among medical organizations and health authorities in their use and consequences. Appreciations vary from outright rejection to interest in its adoption by public health systems as part of their services.
View Article and Find Full Text PDFHum Vaccin Immunother
December 2025
Centre for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium.
In April 2024, the Adult Immunization Board convened a technical meeting to explore the latest strategies and identify exemplary approaches regarding the implementation of vaccines for adults into Europe's National Immunization Programs (NIPs). The meeting was built around three pillars: decision making for introducing a new vaccine, implementation, monitoring, and evaluation. The increasing number of new vaccines available in a context of competing health priorities warrants transparent and evidence-based decision-making processes for vaccine introduction.
View Article and Find Full Text PDFPharmacoepidemiol Drug Saf
January 2025
Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan.
Purpose: This study aimed to obtain a better understanding of the characteristics of the risk management plans (RMP) and the background regulatory policies governing them, in the European Union (EU) and Japan. This was done by descriptively comparing the safety concerns (SCs) listed in the RMP and examining their relationships with product labeling.
Methods: Information regarding SCs was collected from the published RMP of both the EU and Japan for the targeted products-all of which were commonly approved in both regions.
J Pharm Policy Pract
December 2024
School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Background: The increase in the consumption of herbal medicines and their documented adverse reactions (ARs) necessitate countries to have good pharmacovigilance (PV) systems at all levels. PV systems should be frequently assessed in a systematic manner with available harmonised tools to monitor the implementation of efforts, strengthen the systems and identify areas for improvement.
Objectives: This study aimed to assess the performance of pharmacovigilance and its quality systems for monitoring herbal medicine safety at the National PV Centre at the Tanzania Medicines and Medical Devices Authority (TMDA), manufacturers and herbal medicine marketing authorisation holders (MAHs) to identify gaps, challenges and opportunities for improvement.
Biomedicines
December 2024
Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
IL-6R inhibitors are widely used in many inflammation-related diseases, especially so during the COVID-19 pandemic. However, their relationship with gastrointestinal perforations (GIPs) has been reported more and more. We comprehensively analyzed IL-6R inhibitors in association with GIPs from the United States FDA Adverse Event Reporting System (FAERS).
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