Amman: The Jordan Food and Drug Administration (JFDA) has issued a new regulatory framework outlining tighter controls on promotion of specific medicines.
The move aims to ensure patient safety and prevent misuse, which could diminish the effectiveness of medications or lead to serious side effects, it said.
JFDA Director General Nizar Mheidat said the regulations are meant to reinforce the proper promotion of medications, particularly those with higher risk. These include registered drugs under the Controlled Access Program (CAP), those requiring a Pregnancy Prevention Program (PPP) for women of childbearing age, registered antibiotics, narcotics, psychotropic substances, and medicines dispensed exclusively in hospitals.
The new guidelines strictly prohibit the promotion of any medicine before registration, even if it has been authorized for import or received an emergency license. It also bans the promotion of information out of the official drug registration file, or a summary of product characteristics
.
Further controls include the prohibition of promoting unapproved indications or those not listed in the leaflet. The regulation mandates adherence to guidelines for distribution of valid drug samples and requires prior approval for any advertising related to non-prescription drugs in the media, including digital platforms and social media, to ensure accuracy before publication, the JFDA said.
The regulation also stipulates adding promotion clarifications, depending on the drug category. For example, promotional materials for antibiotics must include the phrase, “any prescription of antibiotics with an effect on bacterial resistance must be explained,” while materials for vaccines must state “limiting the use of these drugs to a category of patients.”
Mheidat stressed that the JFDA will enforce these regulations rigorously, with violators facing penalties as outlined in the Drug and Pharmacy Law and its amendments.
Additionally, the promotion of medicines directly to patients is strictly prohibited in an
y form, with approved promotional materials directed solely at healthcare providers, excluding any unsubstantiated medical claims, in line with the 2016 pharmaceutical promotion guidelines.
Source: Jordan News Agency