Regulatory Requirements and Comparison of Approval of New and Generic Drugs in the United States of America and Japan: Implication for Future Strategies

摘要

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.