Abstract

COMPARATIVE STUDY OF KEY REGULATORY REQUIREMENTS FOR THE SUBMISSION OF DOSSIERS TO USFDA, WHO, SINGAPORE (ASEAN) WITH EMPHASIS ON APPROVAL OF GENERIC DRUGS

K. Sai Swetha*, Dr.N.Srinivas

ABSTRACT

The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. Background: The purpose of the present study was to compare dossier requirements of different countries like USFDA (United States Food and Drug Administration), WHO (World Health Organization) and ASEAN. Methods: Collection of the following dossier format of USFDA (United States Food and Drug Administration), WHO (World Health Organization) and ASEAN (Association of South East Asian Nation) Identifying the critical and major differences among those three dossiers related to technical document. Comparison of common technical document for those critical and major differences among three countries (USFDA, WHO & ASEAN) Results: After pooling all the information and data that was collected in due course of time of the research, was made into comparative chart format where it is shown that among group of countries (like WHO, ASEAN) and also these guidelines were compared with regulated market USFDA. It was found that, there was less harmonization and various differences in dossier requirements. Discussion: Regulations may create costs as well as benefits and may produce unintended reactivity effects, such as defensive practice. Efficient regulations can be defined as those where total benefits exceed total costs. Regulatory reviews and communication with the applicants will be facilitated by a standard document of common elements. In addition, exchange of regulatory information between Regulatory Authorities will be simplified. Conclusion: Regulation creates, limits, or constrains a right, creates or limits a duty, or allocates a responsibility. Regulation can take many forms: legal restrictions promulgated by a government authority, contractual obligations that bind many parties, self-regulation by an industry such as through a trade association, social regulation, and co-regulation, third-party regulation, and certification, accreditation or market regulation.

Keywords: Regulatory requirements, USFDA, WHO, ASEAN, HSA.