AMMAN — Updating regulations that govern post-approval changes and post-marketing drug safety is very important to protect customers and drug stores, according to the Jordan Food and Drug Administration (JFDA).
JFDA Director General Hayel Obeidat on Monday said the Kingdom already has a new bylaw that was issued last year to regulate post-approval changes in drugs, but “we will modify some of its articles this year... to comply with the local market”.
The post-approval changes protocols and regulations cover specific modifications that a company would like to implement during the lifecycle of a pharmaceutical product.
“Our main objective at the JFDA is to realise health safety and monitor the safety of medicines in a way that also ensures protecting drug stores,” Obeidat told The Jordan Times on the sidelines of a workshop organised by APEX Medical Jordan on “Scale-up and post-approval changes and post-marketing pharmacovigilance”.
Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem, according to the World Health Organisation website.
Participants representing the sector from several countries of the region are reviewing regulations related to post-approval changes in medicines at the two-day workshop.
Addressing participants, Hanan Kakish, regional technical and innovation director at APEX, highlighted the importance of regulating post-approval changes to provide the most effective public health protection.
However, having too many restrictions on this policy could end up with low efficiency and a high cost of manufacturing, Kakish said.
According to Obeidat, companies submit details to prove they can manage the impact of the post-approval change for specific medicines.
