A comparative study of common technical document in different regulated market (Only Abstract)

Abstract

Background and Aim: Drug regulation is a practice carried out to control the sale and distribution of drugs by international regulatory authorities such as the Food and Drug Administration or nationally by office of Drug Controller General of India. Need for regulation of medicines in modern era was first realized in the 19th century due to death of 100 people because of consumption of diethylene glycol in the form of sulfanilamide elixir in the USA. Thalidomide disaster proved to be a turning point in the history of drug regulation. This made the regulatory bodies to prepare and implement guidelines related to quality, safety, and efficacy of drug substances and drug products. It was also made mandatory for the industries that while filing any application for approval for new drug substances or products, they need to prove quality, safety, and efficacy of products through proper documentation. Most of the regulatory agencies have their own format for filing an application for seeking approval for marketing a drug product. A common format was adopted by the International Conference on Harmonization (ICH) on industry recommendation. This is known as common technical document (CTD). CTD was agreed on as the “well-structured common format” for the organization of the technical requirements to be submitted to regulatory agencies. Methods: In this review, various aspects of CTD have been discussed including its different modules and structure. Moreover, a comparative study of contents and formats of different regulatory agencies have also been reported. Results: CTD is organized into five modules. Since Module 1 is region specific, its content is specified by regional agencies so as to customize it according to the regional requirements. However, modules 2-5 are common for all ICH countries. Conclusion: CTD is widely accepted by various countries across the globe irrespective of their ICH membership. It has proven to be a breakthrough documentation system in drug approval process. This not only reduces the unnecessary efforts of both regulators and pharmaceutical companies but also reduces the time frame in which drug becomes available to patients