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1 Notice To Applicants (Npra)

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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120 views1 page

1 Notice To Applicants (Npra)

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.

Uploaded by

arry young
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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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 HSA_TP_Enquiry@hsa.gov.sg
(Singapore).

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

 HSA (Singapore): HSA_TP_Enquiry@hsa.gov.sg


 NPRA (Malaysia): npra@npra.gov.my

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