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Health Sciences Authority
Regulatory Updates

26 Sep 2016: Removal of Requirement of Submission of the Singapore Quality Overall Summary (SQOS)

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

26 September 2016

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

The Singapore Quality Overall Summary (SQOS) was introduced in 2007 to provide information specific to product registration in Singapore. Over the years, the Therapeutic Products Branch (TPB) has received industry feedback that the SQOS is cumbersome to complete. Additionally, the information required by the SQOS may not be readily available, thereby delaying application submission.

In response to feedback received, several rounds of discussions and consultations were held before the decision was made to remove the requirement of submission of the SQOS. Information related to the product to be registered in Singapore will be obtained via the screening checklist in future. The current documentation submission requirements, including the ICH CTD / ASEAN CTD Quality Overall Summary will remain.

The removal of the SQOS will be effective from 1 November 2016.

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