Jordan Enacts Updated Regulations For Biosimilar Drug Registration

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

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