Customer Requirement: A regional regulatory authority in the MENA region sought to address critical gaps in their pharmacovigilance (PV) systems to enhance drug safety monitoring for a portfolio of their products, across the region. The key objectives of the PV system were as follows:
- Establishing robust PV systems in underdeveloped regions
- Aligning PV standards with international and applicable regulations (i.e., GVP, Arab GVP, ICH, WHO guidelines)
- Providing technical tools, training, and resources for healthcare professionals and stakeholders
- Streamlining processes to improve adverse event reporting and signal detection efficiency
- Understanding the local QPPV and MAH obligations and responsibilities for MENA countries
Problem Statement: Pharmacovigilance systems in the MENA region face several challenges. For example, in countries like Saudi Arabia and Egypt, there is an established and relatively robust PV framework and systems while countries such as Yemen or Libya remain at rudimentary stages. Variability in PV regulations and resources across the MENA region creates efficiencies. For example, certain MENA countries require a QPPV to be a resident of the country, whereas others do not. Certain countries do need a “QPPV” but a local safety person (LSP) to manage front-end PV activities. Furthermore, healthcare professionals and the public do not have complete or holistic knowledge about PV practices and their association with patient safety. Certain countries lack accessible and user-friendly PV platforms for adverse event reporting and monitoring.
DDReg’s Solutions and Processes Adopted: In order to address these challenges, DDReg designed a tailored approach towards helping the company develop their PV system in regions with fragmented PV framework.
Given the DDReg PV team’s experience of working within the MENA region and navigating through varying regulations, the team was able to develop a comprehensive roadmap for the priority countries of the pharma company. This primarily focused on adverse event reporting, signal detection, local QPPV requirements, and risk management. The team also helped to design workflows for
adverse event reporting,
signal detection, and risk assessment in order to improve efficiency, with the objective of streamlining national PV systems.
Furthermore, the team developed a comprehensive repository of MENA-specific PV regulations and guidelines. This centralized database allowed easy access and reference to latest regulatory requirements for each country in the region. By systematically tracking updates from regulatory authorities, the repository ensure that all processes remained compliant with evolving standards. Not only did this database help in streamlining regulatory referencing but also help various stakeholders associated with the pharma company to make informed decisions in alignment with local and international PV practices.
Achievements and Business Impact: DDReg’s solutions and the processes adopted helped in establishing operational PV systems for the pharmaceutical company in countries with an underdeveloped PV framework and enhanced those in countries with developed framework. DDReg strengthened its presence in the MENA region as a trusted partner for tailored
PV solutions, contributing to improved patient safety and public health outcomes.
