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  • 1 Notice To Applicants (Npra)

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    The Health Sciences Authority of Singapore and the National Pharmaceutical Regulatory Agency of Malaysia are launching a pilot initiative for a joint collaborative assessment of generic medicines registration applications filed with both agencies. The goal is to reduce regulatory burden for industry by allowing common technical dossiers and facilitate simultaneous market approval in both countries. They are seeking initial expressions of interest from generic drug applicants who are willing to participate in this pilot program, which will focus on an immediate release oral solid dosage drug supported by bioequivalence data. Applicants should submit their expression of interest form simultaneously to both agencies by the specified date if interested in participating.

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    The Health Sciences Authority of Singapore and the National Pharmaceutical Regulatory Agency of Malaysia are launching a pilot initiative for a joint collaborative assessment of generic medicines registration applications filed with both agencies. The goal is to reduce regulatory burden for industry by allowing common technical dossiers and facilitate simultaneous market approval in both countries. They are seeking initial expressions of interest from generic drug applicants who are willing to participate in this pilot program, which will focus on an immediate release oral solid dosage drug supported by bioequivalence data. Applicants should submit their expression of interest form simultaneously to both agencies by the specified date if interested in participating.

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    46 views1 page

    1 Notice To Applicants (Npra)

    Uploaded by

    arry young
    The Health Sciences Authority of Singapore and the National Pharmaceutical Regulatory Agency of Malaysia are launching a pilot initiative for a joint collaborative assessment of generic medicines registration applications filed with both agencies. The goal is to reduce regulatory burden for industry by allowing common technical dossiers and facilitate simultaneous market approval in both countries. They are seeking initial expressions of interest from generic drug applicants who are willing to participate in this pilot program, which will focus on an immediate release oral solid dosage drug supported by bioequivalence data. Applicants should submit their expression of interest form simultaneously to both agencies by the specified date if interested in participating.

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    Request for Expressions of Interest (EOI) to Participate in the HSA-NPRA Generic Medicines Work

    Sharing Initiative

    Dear Generic medicines applicants,

    As part of our efforts to further strengthen the bilateral cooperation between the Health Sciences
    Authority (HSA) of Singapore and the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia
    in the area of pharmaceutical regulation, we are pleased to announce the launch of the HSA-NPRA
    Generic Medicines Work Sharing Initiative for generic medicines registration applications filed with
    both the HSA and NPRA. This initiative entails a joint collaborative assessment of the application with
    the intent to benefit the industry in terms of reduction in regulatory burden with the filing of common
    dossiers to both Agencies. It is also anticipated that the initiative would facilitate simultaneous market
    entries of generic medicines in both countries.

    As a pilot, we are targeting a potential candidate of an immediate release oral solid dosage form
    supported by bioequivalence data. Initial expressions of interest to participate in this pilot should be
    submitted to both Agencies. It is encouraged that Part II of the ACTD (or Modules 2 and 3 of the ICH
    CTD) of the application submitted to both Agencies contain common information i.e. same technical
    dossier. Any differences in the dossier must be clearly identified and summarized by the applicant
    using the template provided within the Expression of Interest form. Country-specific administrative
    documents (i.e. Part I for ACTD or Module 1 for ICH CTD) remain as per the requirements of the
    respective Agencies.

    The application should be submitted to both Agencies simultaneously on the same day. Once the
    application is accepted for evaluation by both Agencies, the review will take place simultaneously. It
    can be expected that any queries related to the technical dossier will be similar or the same. This
    means that the applicant will most likely not be required to address two separate sets of queries.
    While it is anticipated that the work sharing review will arrive at the same assessment, the individual
    Agency will make its own independent decision. The processing time of the application will not be any
    worse-off than the standard timelines of the respective Agencies. Additional information on the work
    sharing procedure and various milestones of the process are described in the document Operational
    Procedures.

    Applicants who are interested in participating in the pilot should submit their completed Expression
    of Interest (EOI) form to the Director of NPRA (Malaysia) and [email protected]
    (Singapore).

    For further information, please contact us as follows with the email subject “HSA-NPRA Generic
    Medicine Work Sharing Initiative”:

     HSA (Singapore): [email protected]


     NPRA (Malaysia): [email protected]

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