Removal of Singapore Quality Overall Summary from Drug Product Registration in Singapore

The Singapore Quality Overall Summary (SQOS) was introduced in 2007 to provide information specific to product registration in Singapore. It was based on the Canadian process and adopted to promote applicant understanding of their product and to ensure the dossier is complete, thus reducing review timelines. The Therapeutic Products Branch (TPB) has received feedback from the industry indicating that the Singapore Quality Overall Summary (SQOS) is tedious to complete. The main objective for the introduction of the SQOS is for industries to provide information specific to product registration in Singapore. However, some of the information that it requires may not be readily available thus resulting in a delay in application submission.

Based on feedback received by the TPB, several rounds of discussions and consultations were held before they decided to remove the requirement of submission of the SQOS. All information related to the product to be registered in Singapore will be obtained via the screening checklist in future.

Do note that the current documentation submission requirements, including the ICH CTD/ASEAN CTD Quality Overall Summary will remain.

The removal of the SQOS will take effect from 1 November 2016.

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