ABSTRACT
The requirements for drug approval may differ from one country to another; however, the approval process usually goes through the same general steps. In the United States, the Food and Drug Administration (FDA) requires that the pharmaceutical company les a new drug application (NDA) for the approval of a new molecular entity that has never been marketed in the United States before. In the NDA, the company should provide comprehensive drug information and results of investigations that prove that the new drug is safe and effective. If the NDA is approved, the drug can be marketed in the United States as “innovator product” exclusively by that drug company for the remaining of the patent period. When the drug patent expires, other pharmaceutical companies can request marketing “generic products” for the same active drug. A generic drug product is the same as the innovator drug product in dosage form, route of administration, strength, quality, performance, and intended use. For marketing generic products, companies have to le abbreviated new drug application (ANDA). The ANDA is not required to include evidence of drug safety and effectiveness; however, it should include evidence of bioequivalence (BE), that is, a proof that the performance of the generic product in vivo is similar to that of the innovator product. Once approved, applicant(s) can manufacture and market the generic drug product to provide safe, effective, and low-cost alternative drug products. Supplemental applications are
usually led whenever changes are introduced to the manufacturing process, formulation, or indications of approved drugs to prove that all the qualities originally set for the product are still met.
