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This application is a service of the Singapore Government.

Health Sciences Authority

Industry Communications on Therapeutic Product Regulations

13 Nov 2017: New initiatives for Registration of Therapeutic Products

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6 March 2017: Update on pilot project for MIV-1 verification

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29 Dec 2016: Clarification on Retention of Therapeutic Product Registration and Update to Guidance on Therapeutic Product Registration

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31 Oct 2016: Update on implementation of Health products: Revision of Guidance on Therapeutic Product Registration (1 Nov 16)

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

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.

 

1 Aug 2016: Industry feedback on Revised Guidance on Therapeutic Product Registration

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20 June 2016: Pilot project on MIV-1 Verificiation Route

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27 July 2015: National Consultation on the Proposed ASEAN Sectoral Mutual Recognition Agreement (NRA) on Bioequivalence (BE) Report

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13 April 2015: Update on ASEAN Mutual Recognition Arrangement (MRA) on GMP Inspection and GMP Conformity Assessment

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9 Feb 2015: Streamlining of MIV-1 screening processes

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1 Oct 2014: Update on HPRG's initiatives - Pilot Project on Screening Turnaround Time and MIV Updates

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Update (20 Oct 14): 

Due to a delay in the enhancement of PRISM system for these changes, we wish to update you that the implementation date for the pilot project on screening TAT for MIV-1 applications, as well as the other initiatives pertaining to MIV applications stated in the email notification below (1 Oct 14), will be delayed from 01 November 2014 to 02 December 2014


March 2014:

Announcement – Update on Guidance on Medicinal Product Registration in Singapore

Related documents:


8 Jan 2014:

Updates for Guidance on Medicinal Product Registrationin Singapore

Revised MIV-1/MIV-2 checklists (effective 1 April 2014)


27 Sept 2013:

Industry Consultation on Drug Product Stability Data Requirements and ASEAN Variation Guideline Implementation (closing date 18 October 2013)

The consultation period for this paper is closed.


25 June 2013:

Industry Consultation on Site Specific DP Stability Requirement

The consultation period for this paper is closed.


March 2012:

Announcement - Revision to Guidance on Medicinal Product Registration in Singapore