Pharmacovigilance services in UAE

The pharmacovigilance landscape in the UAE is one that is rapidly developing to ensure patient safety. The Ministry of Health and Prevention (MOHAP) oversees all activities within UAE’s healthcare system including pharmacovigilance. Each Emirate has appointed a national healthcare authority that is responsible for monitoring the respective healthcare system. pharmacovigilance guidelines that are followed are based on those of the EU GVP and Arab GVP which dictates requirements for PSMFs, RMPs, ICSRs, PSURs/PBRERs, signal detection as well as QPPV. Marketing Authorization Holders must appoint a local QPPV that holds UAE residency. Foreign pharmaceutical organizations who have a local UAE agent must have a local safety responsible person that lives in the UAE, and should ideally be a physician or pharmacist. The MOHAP also requires a National Pharmacovigilance File that has additional information on ADRs, PSURs and RMPs. Healthcare professionals and patients submit their ADR reports to the MOHAP which can be in paper form, via emails, or through ‘smart applications’. Furthermore, all ICSRs and any data the provides insight to the safety profile of a pharmaceutical product, which could impact patient safety, must be submitted to MOHAP as soon as possible. The MOHAP is active in implementing a robust pharmacovigilance system to safeguard public health by offering various services. For example, the MOHAP website provides services for ‘Approval of Pharmacovigilance Officer of Pharmaceutical Facility’ and ‘Evaluation of Pharmacovigilance Plan for Pharmaceutical Facility and its Subsidiaries

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in UAE that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.