DDReg Pharma

Pharmacovigilance services in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) is the main authority under the Ministry of Health (MOH) for the safe use of food, drugs, and biological and chemical substances. Under SFDA the National Pharmacovigilance Centre (NPC) was launched as its pharmacovigilance sub-division: with a focus mainly on the safety profiles and ensuring a positive benefit-risk for all the medications. Since its establishment, most pharmacovigilance activities, such as adverse drug reactions (ADRs) reporting, risk management plans (RMPs), Periodic Safety Update Report/Periodic Benefit-risk Evaluation Report (PSUR/PBRER), individual case safety report (ICSR), signal detection, data mining, and risk communication, are a part of NPC. Adverse reactions can be reported by physicians, pharmaceutical companies, and the general public online or by email, by filling out paper forms and sending them by email, fax or mail or by call and report the ADRs. In addition, Saudi Arabia requires a dedicated QPPV residing in the country to oversee the pharmacovigilance activities. For international Marketing Authorization holders, it is mandatory for them to develop and maintain a local pharmacovigilance system in Saudi Arabia which is documented in a file called “Pharmacovigilance Sub-System File (PSSF),” Also, the local MAHs document the ADR information in the company’s global PV system Pharmacovigilance System Master File (PSMF). Although, Saudi Arabia has an advanced PV system in place, underreporting from the public and lack of PV awareness are some of the pharmacovigilance challenges faced.

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 Saudi Arabia 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.

DDReg pharmacovigilance Services portfolio include:
ICSR Processing and Submission
Risk Management Plan
Aggregate Reports
Signal Management
Responsible Person for Pharmacovigilance (RPPV)/QPPV Services
PV Audit & Compliance
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