Issuance of 2026 Biosimilar Drug Registration Instructions in the Official Gazette
Amman2 min read
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The "2026 Biosimilar Drug Registration Instructions" were published in the Official Gazette this Thursday, issued in accordance with the provisions of the Drug and Pharmacy Law No. (12) of 2013 and the Jordan Food and Drug Administration (JFDA) Law No. (41) of 2008, effective from the date of their publication.
These instructions apply to biosimilar drugs containing active substances with well-defined protein characteristics, manufactured using modern technologies such as recombinant DNA techniques. The instructions exclude blood-derived products, immunological vaccines, allergens, tissues, genes, and stem cell therapy products from their provisions.
According to the instructions, the registration of biosimilar drugs is prohibited unless their manufacturing sites are approved in accordance with the provisions of the current instructions for the accreditation and re-evaluation of manufacturing sites. It also requires the accreditation of manufacturing sites for the Master Cell Bank (MCB) and the Working Cell Bank (WCB) under a Good Manufacturing Practice (GMP) certificate or a Good Laboratory Practice (GLP) certificate.
The instructions emphasize the prohibition of circulating any biosimilar drug unless it has been registered, priced, and granted a registration number by the Jordan Food and Drug Administration based on a file that meets the approved documents and requirements.
The instructions clarify that the registration of a biosimilar drug does not constitute approval for its registration in all its concentrations and pharmaceutical forms, as a separate registration application must be submitted for each concentration or pharmaceutical form individually.
Under these instructions, the Administration is granted the right to request any additional information or studies necessary to verify the safety, efficacy, and quality of biosimilar drugs, provided that the request is justified. These instructions also repeal the "2015 Biosimilar Drug Registration Bases" and their amendments.
