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This application is a service of the Singapore Government.

Health Sciences Authority

Industry Communication

Communication and updates to the clinical trials regulatory processes will be made available here. In addition, any new or updated guidelines that are open for consultation will be included in this section.


Presentations

Date Event

14 Oct 2016
27 Oct 2016

Training Session: Enhanced PRISM E-Services for Clinical Trials

The following sets of slides were presented at the training sessions for enhanced PRISM E-Services for Clinical Trials. In tandem with the implementation of the new Regulations on Clinical Trials and Clinical Research Materials on 1 November 2016, the existing PRISM e-services for clinical trials is being enhanced to facilitate the implementation of these new regulatory controls. The new enhanced PRISM will be rolled out on 1 November 2016.

CRM Notification Submission Download.IconPdf File Size (1.78 Mb)
CTA/CTN/CTC Application Submission Download.IconPdf File Size (2.06 Mb)
Amendment Submission Download.IconPdf File Size (1.03 Mb)
Other Clinical Trials Submissions, Track & Enquire @ PRISM Download.IconPdf File Size (868 Kb)
Reference: Amendment Matrix for CTA/CTN/CTC Amendment Application Download.IconPdf File Size (865 Kb)

25 Aug 2016
1 Sep 2016
29 Sep 2016

CTB Workshop: An Update on the Regulatory Controls of Clinical Trials and Clinical Research Materials (CRM)

The following sets of slides were presented at the workshops organised by the Health Sciences Authority (HSA) in August and September 2016. The workshops were intended to inform stakeholders involved in clinical research in Singapore on the new regulatory requirements for clinical trials and CRM, and to facilitate stakeholders’ transition to the new framework, which will be effective from 1 November 2016.

General Clinical Trial Requirements Download.IconPdf File Size (0.98 Mb)
Informed Consent Download.IconPdf File Size (638 Kb)
Labelling of Therapeutic Products and Medicinal Products Download.IconPdf File Size (512 Kb)
Clinical Research Materials (CRM)

Note: Slides 13-15 have been added to clarify on the various import routes for TP and MD; slide 15 has been revised on 24 Mar 2017 due to feedback from industry.
Download.IconPdf File Size (990 Kb)
22 Aug 2012 Combined CRP-CRCS Forum: Globalisation of Clinical Trials

The following set of slides was presented at the Combined CRP-CRCS Forum on 22 August 2012 as an introduction to the upcoming Clinical Trial Register. The Clinical Trials Register was officially launched on 1 September 2012 and can be accessed via this page.

Singapore Clinical Trials Register Download.IconPdf File Size (1.1 Mb)
15 Mar 2012 HSA Briefing & Workshop on Clinical Development of Medical Devices

The Health Sciences Authority has organised a 1-day regulatory workshop on the clinical development of medical devices. This workshop was intended to prepare stakeholders involved in the clinical development of medical devices in Singapore to be better equipped on the key clinical and regulatory aspects.

Note: For current regulatory controls for medical devices used in clinical trials, please refer to Clinical Trials - FAQs for more information.
Clinical Development of Medical Devices Download.IconPdf File Size (4.2 Mb)

 


Communications

Date Communication Download
16 Mar 2015 Notification of Serious Breaches of the Singapore Guideline for Good Clinical Practice, Trial Protocol or Clinical Trial Regulations Download.IconPdf File Size (1.1 Mb)
1 Sep 2011 Import of Clinical Trial Materials (CTM) GST Relief Arrangements (effective from October 2011) Download.IconPdf File Size (53 Kb)
23 Sep 2009 Implementation of GCP Inspection Framework - Memo to Applicants Download.IconPdf File Size (837 Kb)
11 Jun 2009 Administrative Changes to Clinical Trial Protocols and Patient Informed Consent Forms Not applicable
4 Nov 2008 Launch of Expedited Safety Report Module Download.IconPdf File Size (48 Kb)
22 Aug 2007 Updates to the clinical trials safety reporting requirements (September 2007) Download.IconPdf File Size (77 Kb)
6 Jan 2006 Changes to the clinical trials application process Download.IconPdf File Size (83 Kb)

 


Presentations - Common GCP Inspection Findings

Date Presentation Download
16 Jan 2017 Common GCP Inspection Findings in 2016 Download.IconPdf File Size (309 Kb)
3 Dec 2015 Common GCP Inspection Findings in 2015

(Presented in Combined CRP-CRCS Forum)
Download.IconPdf File Size (498 Kb)
12 Dec 2014 Common GCP Inspection Findings in 2014

(Presented in Combined CRP-CRCS Forum)
Download.IconPdf File Size (1 Mb)
13 Nov 2013 Common GCP Inspection Findings in 2013

(Presented in Combined CRP-CRCS Forum)
Download.IconPdf File Size (903 Kb)
2012 Common GCP Inspection Findings in 2012 Download.IconPdf File Size (1.5 Mb)
2011 Common GCP Inspection Findings in 2011 Download.IconPdf File Size (881 Kb)
2011 Case Studies from GCP Inspection Findings in 2011 Download.IconPdf File Size (2.1 Mb)
2010 Common GCP Inspection Findings in 2010 Download.IconPdf File Size (739 Kb)