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.