Generic drugs provide consumers with a safe, effective, lower-cost alternative compared to brand name drugs. Before a generic drug can be legally sold in the Canadian or U.S. markets, it must be approved by the Therapeutic Products Directorate (TPD) of Health Canada or the FDA, respectively.
To obtain approval, companies must submit an Abbreviated New Drug Submission (ANDS) in Canada, or an Abbreviated New Drug Application (ANDA) in the U.S. Pre-clinical and clinical data are not required to establish safety and efficacy of generic drugs, hence the term "abbreviated." Instead, bioequivalence between the innovator drug and the generic drug must be well established.
Our regulatory team can assist in the determination of bioequivalence providing all the tools necessary for successful ANDSs and ANDAs. Explore our additional services for pharmaceuticals.
Learn how we can help you successfully bring your pharmaceutical to market.