Amman, May 19 (Petra) — The Jordan Food and Drug Administration
(JFDA), through its Rational Drug Use and Pharmacovigilance
Department, has achieved a qualitative milestone in drug safety by
discovering an error in the medical leaflet of an innovator product
manufactured by a global pharmaceutical company and marketed across
Europe with the same leaflet.

According to a JFDA statement released on Tuesday, the discrepancy
was spotted during a routine review of an update to the product’s
leaflet. Based on an intensive scientific study and an evaluation of
the drug’s data and specifications, the pharmacovigilance department
raised its observations. Consequently, the manufacturing company was
notified through its local agent in Jordan. Upon reviewing the
notice, the manufacturer confirmed the validity of Jordan’s findings,
leading to the withdrawal of the innovator drug’s leaflet from all
registered global markets to carry out the necessary updates in
response to the JFDA’s feedback.

During an honoring ceremony for pharmacovigilance specialist Ghadir
Al-Qawasmi, JFDA Director General Rana Obeidat praised Al-Qawasmi’s
pioneering role in pharmacovigilance and drug safety data analysis.
Obeidat noted that this effort directly contributed to regional
health authorities adopting the update and implementing it across
circulated medical leaflets, reflecting the advanced scientific and
technical expertise housed within the administration.

Obeidat emphasized that this achievement embodies the efficiency and
excellence of the administration’s experts on an international level.
She added that it underscores the strength of Jordan’s regulatory
frameworks and technical procedures, reinforcing the JFDA’s role as a
trusted reference authority in drug regulation that ensures the
availability of safe and effective medicines in line with global best
practices. This milestone further bolsters local, regional, and
international confidence in the JFDA and its specialized technical
capabilities.

//Petra// AF