Jordan Enacts Updated Biosimilar Drug Registration Instructions of 2026
核心洞察
Jordan published the updated Biosimilar (搜索) Drug Registration Instructions of 2026 in the Official Gazette, replacing the Biosimilar Drug Registration Principles of 2015 and taking immediate effect.
The framework covers biosimilars containing well-characterized protein active substances made via modern biotechnology such as recombinant DNA techniques, while excluding blood-derived products, vaccines, allergens, gene and stem cell therapies.
Biosimilars now require JFDA prior certification of manufacturing facilities, including GMP or GLP approval for Master and Working Cell Banks, before registration or distribution.
Jordan has brought updated biosimilar (搜索) registration rules into force, with the Official Gazette publishing the "Biosimilar Drug Registration Instructions of 2026" on Thursday. The regulations take effect immediately under the Drug and Pharmacy Law and the Food and Drug Administration Law, and they replace the former "Biosimilar Drug Registration Principles of 2015" and its amendments.
Scope of the new framework
The instructions apply to biosimilar (搜索) medicines containing well-characterized protein active substances produced using modern biotechnology, such as recombinant DNA techniques. The framework explicitly excludes blood-derived products, vaccines, allergens, tissue-based products, gene therapies, and stem cell treatments.
Facility certification becomes a prerequisite
Under the new rules, biosimilars cannot be registered or distributed without prior certification by the Jordan Food and Drug Administration (搜索) (JFDA) of their manufacturing facilities. That certification includes Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) approval for both Master Cell Banks and Working Cell Banks.
All products must additionally be registered, priced, and assigned an official registration number before they can enter the market.
Formulation-specific applications and data requests
Companies must submit separate registration applications for each dosage form and strength. 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.
The updated instructions arrive alongside separate enforcement activity by the regulator. The JFDA, in cooperation with security agencies, has referred 30 websites and digital platforms to the relevant authorities since the beginning of the year for illegally promoting and selling medicines. The agency said online drug sale violates the legal framework, which restricts medicine disbursement to official pharmacies under the supervision of licensed pharmacists, in accordance with the Pharmacy and Drug Law No. 12 of 2013 and its amendments. The JFDA urged professional associations and relevant bodies to cooperate in reporting violations.