• New chemical entity:
A drug molecule that has never been marketed in Saudi Arabia.
• Known active substance:
A new dosage form, strength, route of administration or indication of an active ingredient already marketed in Saudi Arabia.
• Biological drug:
Medicinal products derived from a variety of natural sources or produced by biotechnology methods and other cutting-edge technologies. They include a wide range of products such as vaccines, blood and blood components, allergenics, advanced therapy medicinal products (ATMPs), recombinant proteins and biosimilars.
• Biosimilar drug:
Therapeutic proteins produced by recombinant deoxyribonucleic acid (DNA) technology or gene expression method following the footsteps of one licensed reference biotechnological product. They are complex and heterogeneous in their nature; hence they are not considered generics, but as closely similar to the innovator’s drug as possible.
• Blood product:
They are a wide range of medicinal product sourced from human blood or plasma (source material) that can be collected and tested at “Blood Establishments” and obtained by industrial process “Fractionation” of human plasma of a large number of donations (up to tens of thousands) that are pooled together.
Preparations that contain antigenic substances capable of inducing a specific and active immunity against the infecting agent or the toxin or the antigen produced by it.
• Generic drug:
A product created to be equivalent to the innovative/brand name product in dosage form, strength, route of administration, quality, performance characteristics and therapeutic indication(s). SFDA considers drug applications as generic if the innovative is registered in SFDA or a stringent regulatory authority (SRA).
• Fixed combination product:
Combination of two or more active substances in a fixed ratio of doses within a single dosage form as a final drug product. The two or more active ingredients are used concomitantly as separate single active substances products for a combination therapy regimen and/or used separately for different indications.