Singapore HSA and Malaysia NPRA Launch the HSA-NPRA Generic Medicines Work Sharing Initiative

The Health Sciences Authority (HSA) Singapore and the National Pharmaceutical Regulatory Agency (NPRA) Malaysia have launched the HSA-NPRA Generic Medicines Work Sharing Initiative in August 2021. 

This initiative is a work sharing model for the joint collaborative assessment of a generic medicine registration application filed with both regulatory agencies, and aims to enhance leveraging regulatory expertise, reduce regulatory burden as well as facilitate simultaneous market entries of generic medicines in both countries.  

As a pilot, HSA and NPRA are targeting potential candidates 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 (via the Expression of Interest (EOI) form).  

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, and any differences in the dossier must be clearly identified and summarized by the applicant using the template provided within the EOI 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 itself should be submitted to both Agencies as well. Once the application is accepted for evaluation by both Agencies, the review will take place simultaneously.  

More details can be found in “International Collaboration for Therapeutic Products – About the HSA-NPRA Generic Medicines Work Sharing Initiative”, August 2021:  

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