Safety, efficacy and quality of a therapeutic product are the major concerns for the pharmaceutical
companies. FDA and PMDA are the main regulatory authorities in the USA Japan respectively,
that ensure the maintenance of these required parameters by forming standard guidelines
and process for drug approval. These regulatory authorities review a pharmaceutical drug
product from its discovery phase to the marketed product. Dossier plays an important role in the approval
process of a drug product, as it allows both applicants and review team members to evaluate
the data in an effective manner. A dossier consists of five modules containing informative data of
various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper,
the authors focus on an in-depth review of the approval process for new and generic drugs in
the USA and Japan.
Keywords: Regulatory, approval, generic drugs, United sates of America, Japan, FDA and PDMA.
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