Drug safety · 2026
Current Pharmacovigilance Outsourcing Practices in Arab Countries.
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Abdeldayem Ibrahim, Alshammari Thamir M, Palin Karine
Аннотация
BACKGROUND: Outsourcing in pharmacovigilance has grown in the last decade. However, standards and references are lacking in this area, both for initiating and maintaining a long-term outsource relationship. There are differences in the progression of pharmacovigilance systems by regulatory agencies in these countries because only some can meet the requirements for conducting pharmacovigilance activities. This research aimed to provide an overview of the current pharmacovigilance outsourcing regulations in Arab countries, as well as recommending a draft guideline for good PV outsourcing practices that can be used as a starting point for the preparation of a pharmacovigilance outsourcing process standard.
METHODS: The study was an observational study conducted during the period from 1 April 2020 to 31 July 2020, and was rechecked in July 2026 to search for the latest pharmacovigilance legislation on 22 countries that are considered members of Arab League. Regulatory authorities' websites were used as sources of information regarding the pharmacovigilance guidelines. Several documents were reviewed, including the Arab guideline on Good Pharmacovigilance Practices (GVP) version 2, guidelines for countries that have their discrete guidelines (e.g., Egypt, Saudi Arabia, United Arab Emirates (UAE), Algeria, Tunisia, Iraq, Lebanon, Oman, Sudan and Morocco). Additionally, a list of questions was designed for Arab health authorities regarding their current guidelines about pharmacovigilance outsourcing.
RESULTS: Of the 22 Arab countries, 13 countries have pharmacovigilance guidelines; 8 of these 13 countries have pharmacovigilance guidelines with outsourcing sections. The Arab League guideline, Guidelines of Good Pharmacovigilance Practices in Egypt, and Saudi Food and Drug Authority Guideline on Good Pharmacovigilance Practices contain seven modules with outsourcing sections mentioned, while other Arab guidelines for Iraq and Tunisia contain only one module with outsourcing section mentioned.
CONCLUSIONS: This study identified substantial variability in the extent and level of detail of pharmacovigilance outsourcing requirements across the national pharmacovigilance regulations of Arab countries, supporting the need for a more harmonized regional approach. Based on the identified gaps and existing principles of good pharmacovigilance outsourcing practice, the authors propose a structured framework for Good Pharmacovigilance Outsourcing Practice that may serve as a foundation for future regulatory harmonization and support marketing authorization holders, pharmacovigilance service providers, and regulatory authorities in establishing compliant and effective outsourcing arrangements. Further stakeholder consultation and validation are warranted to assess the applicability and feasibility of the proposed framework across different national pharmacovigilance systems in the Arab region.
METHODS: The study was an observational study conducted during the period from 1 April 2020 to 31 July 2020, and was rechecked in July 2026 to search for the latest pharmacovigilance legislation on 22 countries that are considered members of Arab League. Regulatory authorities' websites were used as sources of information regarding the pharmacovigilance guidelines. Several documents were reviewed, including the Arab guideline on Good Pharmacovigilance Practices (GVP) version 2, guidelines for countries that have their discrete guidelines (e.g., Egypt, Saudi Arabia, United Arab Emirates (UAE), Algeria, Tunisia, Iraq, Lebanon, Oman, Sudan and Morocco). Additionally, a list of questions was designed for Arab health authorities regarding their current guidelines about pharmacovigilance outsourcing.
RESULTS: Of the 22 Arab countries, 13 countries have pharmacovigilance guidelines; 8 of these 13 countries have pharmacovigilance guidelines with outsourcing sections. The Arab League guideline, Guidelines of Good Pharmacovigilance Practices in Egypt, and Saudi Food and Drug Authority Guideline on Good Pharmacovigilance Practices contain seven modules with outsourcing sections mentioned, while other Arab guidelines for Iraq and Tunisia contain only one module with outsourcing section mentioned.
CONCLUSIONS: This study identified substantial variability in the extent and level of detail of pharmacovigilance outsourcing requirements across the national pharmacovigilance regulations of Arab countries, supporting the need for a more harmonized regional approach. Based on the identified gaps and existing principles of good pharmacovigilance outsourcing practice, the authors propose a structured framework for Good Pharmacovigilance Outsourcing Practice that may serve as a foundation for future regulatory harmonization and support marketing authorization holders, pharmacovigilance service providers, and regulatory authorities in establishing compliant and effective outsourcing arrangements. Further stakeholder consultation and validation are warranted to assess the applicability and feasibility of the proposed framework across different national pharmacovigilance systems in the Arab region.