Regulatory Landscape for Oral Solid Dosage Form of Dossier Filing in USA and Its Comparison with Canada and EU

Abstract

Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. Branded drugs play an important role in medications, but generics are their cost effective alternatives. Generics are similar to branded drugs in terms of purity, efficacy and are perceived to be safer as compared to new drug molecules, as they tend to be older and time tested. Indian pharmaceutical market of generic drugs is increasing day by day. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Till date, applicants have used many different approaches in organizing the information and the differences in organization of data in each application has made reviewing more difficult and can also lead to omission of critical data or analyses. Such omissions can result in unnecessary delays in approvals. Thus, a common format of submission will help in overcoming these hurdles. Through the International Conference on Harmonization (ICH) process, the Common Technical Document (CTD) guidance’s have been developed for Japan, European Union, and United States. Thus, a brief discussion of the CTD guidelines has been presented in the article which is helpful for the marketing application for generic drugs in US, EU, Canada and India.