Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations
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REVIEW ARTICLE
Effective Pharmacovigilance System Development: EFPIA‑IPVG Consensus Recommendations Tanja Peters1 · Nigel Soanes2 · Maya Abbas3 · Jabeen Ahmad4 · Jean‑Christophe Delumeau5 · Esteban Herrero‑Martinez6 · Mélanie Paramananda7 · Johanna Piper8 · Fairouz Smail‑Aoudia7 · Willemijn van der Spuij9 · Tina Veizovic10 · Gillian Winstanley11 · On behalf of the EFPIA International Pharmacovigilance Group Accepted: 27 September 2020 © The Author(s) 2020
Abstract Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), safety management requirements are generally consistent with ICH guidelines. In a number of countries beyond this scope, requirements may deviate from internationally agreed standards, adding a substantial complexity and increasing burden on the stakeholders involved, whilst the benefit for patients’ safety may not be evident. Committed to fulfilling safetyregulatory obligations in any country where a product licence is held, global pharmaceutical companies have accumulated a broad and deep experience acquired whilst meeting the expectations of a large array of diverse PV systems across the world. These range from sub-optimal frameworks, according to the World Health Organization (WHO) Global Benchmarking Tool, to highly effective resource-optimised PV systems. In order to support countries creating or further developing their PV systems, especially where infrastructure and resources are limited, the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has developed consensus recommendations consistent with harmonised standards for the development and step-wise implementation of key PV system components. These recommendations endorsed by the EFPIA membership constitute the focus of this review article.
1 Introduction Pharmaceutical legislation provides a legal framework to ensure the availability of acceptably safe, effective and highquality medicines to patients. One element of this framework mandates national regulatory authorities (NRAs) and marketing authorisation holders (MAHs) to establish and This paper has been reviewed by IFPMA. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40264-020-01008-0) contains supplementary material, which is available to authorized users. * Jean‑Christophe Delumeau jean‑christophe.de
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