Generic Drugs Regulations and Registration in Indonesia, Malaysia and Vietnam: A Drug Regulatory Case Study

    Published on:February 2022
    Journal of Young Pharmacists, 2022; 14(1):33-36
    Original Article | doi:10.5530/jyp.2022.14.7
    Authors:

    Sandeep DS1,*, Sowmya CR1, Anoop Narayanan V1, Gowrav MP2

    1Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, INDIA.

    2Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, SS Nagara, Mysuru, Karnataka, INDIA.

    Abstract:

    Objectives: The present study describes the generic drug regulations and registration process in three ASEAN countries Indonesia, Malaysia and Vietnam. Methods: For the current study, the information has been taken from guidelines set forth by the respective regulatory authorities of three selected ASEAN countries concerning the technical guidelines available for generic drugs. Relevant data were also collected from regulatory websites and articles from reputed journals. Results: The process of site evaluation, pre-submission, dossier screening, registration and regulatory approval of generic drugs in Indonesia and Vietnam is quite similar concerning the regulations framed by their respective drug regulatory authorities. In Malaysia, Drug Control Authority accepts only web-based online submissions. The applicant for product registration must be registered with the Malaysian Register of Business (ROB) and should become a quest member at the NPCB website. Conclusion: From our studies relevant to the regulatory perspectives, it is concluded that Malaysia had well-framed drug regulations for generic drugs compared to Indonesia and Vietnam.

    Key words: ACTD, ASEAN, Generic drugs, DCA, ROB, NPCB, Dossier.

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