Amman, Sept. 10 (Petra) – The Official Gazette published the updated
“Biosimilar Drug Registration Instructions of 2026” on Thursday,
bringing the new regulations into effect immediately under the Drug
and Pharmacy Law and the Food and Drug Administration Law.

The rules apply to biosimilar medicines containing well-characterized
protein active substances produced using modern biotechnology, such
as recombinant DNA techniques. The framework excludes blood-derived
products, vaccines, allergens, tissue-based products, gene therapies,
and stem cell treatments.

Under the new instructions, biosimilars cannot be registered or
distributed without Jordan Food Drug Administration (JFDA) prior
certification of their manufacturing facilities, including Good
Manufacturing Practice (GMP) or Good Laboratory Practice (GLP)
approval for both Master Cell Banks and Working Cell Banks.

Additionally, all products must be registered, priced, and assigned
an official registration number before entering the market.

Companies must submit separate registration applications for each
dosage form and strength, as approval of one formulation does not
grant blanket registration across all concentrations. The JFDA also
retains the authority to request additional safety, efficacy, and
quality data as needed.

This framework replaces the former “Biosimilar Drug Registration
Principles of 2015” and its amendments.

//Petra// HA