Departments:
1- National Pharmacovigilance and Drug Safety Center (NPC)
The NPC is responsible for detection, assessment and prevention of adverse effects or any other drug-related problem. The NPC is divided into four sections, each section is responsible for carrying out specific pharmacovigilance activity. Below is a summary of each section’s responsibilities:

Data Capture Section: Receive all adverse drug events (ADEs) from marketing authorization holders (MAHs), health care professionals (HCP) and public. Processing of these ADEs include data entry to national database of ADEs, data coding and evaluation. The section is also responsible for communication with several stakeholders by different channels including email and telephone for follow up or request further information.  In addition, data capture section is responsible for monitoring of  MAHs’ qualified person of pharmacovigilance QPPV/Deputy online registration and reviewing the pharmacovigilance systems of MAH. Furthermore DC section is Responsible for sending ADEs reports to the World Health Organization- Uppsala Monitoring Centre (WHO-UMC). 

Signal Detection Section: A signal is defined as a new or incomplete reported information on a possible causal relationship between an adverse event and a drug. The signal detection section is responsible for reviewing the NPC database for potential safety signals as well as other available resources such as the literature, international regulatory authorities decisions and the media. Signal detection is responsible for evaluate, prioritize and assess the causality of all received signals from all different sources.  Detected signals are usually validated and reviewed extensively for possible safety recommendations.

Periodic Safety Update Reports (PSURs) Section: PSUR section is responsible for receiving, archiving, prioritizing and reviewing PSURs received from marketing authorization holders (MAHs) and issuing appropriate recommendations in case of safety issues.

Risk Analysis Section:  This section is responsible for reviewing risk management plans submitted with pharmaceutical products in pre or post marketing stages. Also, if required implement  certain risk minimization measures (RMMs) for certain products.  

2- Benefit- Risk Assessment Department (BRAD)
The BRAD is responsible for the safety and efficacy assessment of the pharmaceutical products submitted for registration and variation of new chemical entity, biologics, biosimilars and health products. The BRAD also responsible for the review and update of products information (SPC and PIL) in both languages Arabic and English for all the products submitted for registration, renewal and variation. 

3- Medication Errors (MED)
Medication Errors Department is responsible for the evaluation of proposed proprietary names for registration, renewal & variation of pharmaceutical products, for their potential to cause sound-alike or look-alike medication errors. Together with reviewing of proposed product designs, labeling and outer packaging for their potential to cause MEs. They are also responsible for communication with marketing authorization holders (MAHs), healthcare institution/ professionals and monitoring for post marketing ME reports, including those presented in periodic safety update reports. Finally, the medication errors department is responsible for performing root-cause analyses of post-marketing medication error reports.