The legal and regulatory framework for vaccine pharmacovigilance

Ankica Gestakovska,Brankica Moskova,Zoran Sterjev,Aleksandra Grozdanova,Aleksandra Kapedanovska Nestorovska,Ljubica Suturkova,Zorica Naumovska

doi:10.33320/maced.pharm.bull.2020.66.03.034

Ankica Gestakovska, Brankica Moskova + Show 5 more

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https://doi.org/10.33320/maced.pharm.bull.2020.66.03.034

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Abstract

The legal and regulatory framework for vaccine pharmacovigilance

Highlights

Vaccine Pharmacovigilance is defined by the CIOMS/WHO Vaccine Pharmacovigilance Working Group as the science and activities related to detecting, evaluating, understanding and communicating adverse events following immunization (AEFI) and other issues related to vaccines or immunization and preventing vaccination or vaccine side effects (CIOMS, 2018)
Since 2018, the Republic of North Macedonia has established an electronic system for reporting adverse drug/vaccine events to enable better accessibility for health care professionals (HCPs) and patients
As we evaluate the available data from the competent authorities, it could be noticed that the Republic of North Macedonia is facing a big problem in reporting ADRs as well as AEFIs

Summary

Introduction

Vaccine Pharmacovigilance is defined by the CIOMS/WHO Vaccine Pharmacovigilance Working Group as the science and activities related to detecting, evaluating, understanding and communicating adverse events following immunization (AEFI) and other issues related to vaccines or immunization and preventing vaccination or vaccine side effects (CIOMS, 2018). Well established pharmacovigilance system enables early detection, an appropriate and timely response to AEFIs, minimization of the negative effects on the public health, and reduction of the potential negative impact on immunization in the population. The legal framework for vaccine surveillance during the clinical phase of vaccine development and postmarketing period is essential for the implementation of good pharmacovigilance practice on a global and national level. This system should empower the public trust in the healthcare system to obtain sufficient vaccination especially for preventable diseases and improve public health nationally and globally (Di Pasquale, 2016; EMA, GVP, 2013)

Materials and methods

Results and discussion

Conclusion