Journal: Journal of Pharmacy Research

Article Id: JPRS-DIR-000096
Title: Comparative study of regulatory requirements for the approval of generic drugs for Association of South East Asian Nation (ASEAN), Gulf Co-Operative Council (GCC) & United States Food And Drug
Category: Drug Information Research
Section: Research Article
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    Background: The purpose of the present study was to compare dossier requirements of different countries like ASEAN (Association of South East Asian Nation), GCC (Gulf Cooperation Council) and USFDA (United States Food and Drug Administration). Methods: Collection of the following dossier format like ASEAN (Association of South East Asian Nation), GCC (Gulf Cooperation Council) and USFDA (United States Food and Drug Administration). Identifying the critical and major differences among those three dossiers (ASEAN, GCC& US-FDA) related to technical document. Comparison of common technical document for those critical and major differences among three countries (ASEAN, GCC & USFDA) 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 ASEAN, GCC) and also these guidelines were compared with regulated market USFDA. It was found that, there was less harmonisation and various differences in dossier requirements. Discussion: In its legal sense regulation can and should be distinguished from primary legislation on the one hand and judge-made law on the other. 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, co-regulation, third-party regulation, and certification, accreditation or market regulation.

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  • About the authors and Affiliations

    Author(s) Name:

    R.Suthakaran

    Affiliation(s) Name:

    Department of Pharmaceutical Chemistry and Drug Regulatory Affairs, Vijaya College of Pharmacy, Hayath nagar, R.R.Dist, Hyderabad, Andhra Pradesh, India

    *Corresponding author.
    R.Suthakaran
    Department of Pharmaceutical Chemistry and Drug Regulatory Affairs
    Vijaya College of Pharmacy,
    Hayath nagar, R.R.Dist,
    Hyderabad, Andhra Pradesh, India
    E-mail: drsutha2010@gmail.com

    Received on:21-11-2013; Revised on: 09-12-2013; Accepted on:17-12-2013

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    Author:

    R.Suthakaran

    Title:Comparative study of regulatory requirements for the approval of generic drugs for Association of South East Asian Nation (ASEAN), Gulf Co-Operative Council (GCC) & United States Food And Drug
    Journal:Journal of Pharmacy Research
    Vol(issue):8 (January )
    Year:2014
    Page No: (59-63)
  • Experimental Methods Keywords

    Methodology:Collection of data ASEAN (Association of South East Asian Nation), GCC (Gulf Cooperation Council) and USFDA (United States Food and Drug Administration)
    Research Materials:Comparative study of regulatory requirements for the approval of generic drugs

Keywords

Regulatory Authorities regulatory information efficient regulations

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