Clinical Research and Regulatory Review

Clinical research is cornerstone of advancement of medicine, particularly medicinal products. Clinical phase of drug research and development ensures medicinal products have acceptable quality, safety, and efficacy profile ahead of being on the market. The New Drug Application (NDA) review process requires the Investigational New Drug (IND) in clinical development to have a stepwise research approach through clinical trials phase I, II, and III, and long-term safety evaluation of drug already on market through clinical trials phase IV. The timelines in clinical development greatly differ in terms of the IND, indication, and regulatory requirements of the targeted market. The regulatory requirements encompass specific laws, regulations and guidelines pertaining to clinical research. To ensure consistency in drug research and development in the three regions: the United States, the European Union (EU) and Japan, the international guidelines for conducting clinical trials and data evaluation are set, implementing harmonization of regulatory requirements since 1990.