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Import of Clinical Trial Materials (CTM) GST Relief Arrangements (effective from October 2011)
File Size: (53 Kb)
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Implementation of GCP Inspection Framework - Memo to Applicants (September 2009)
File Size: (837 Kb)
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Administrative Changes to Clinical Trial Protocols and Patient Informed Consent Forms (June 2009)
File Size: (80 Kb)
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Presentations
HSA Briefing: Regulatory Framework for Medical Device Clinical Trials (Aug 2011)
In preparation for the implementation of the Health Products (Clinical Trials) Regulations in 2012, HSA conducted briefing sessions for the industry in August 2011 to update both current and prospective sponsors for clinical trials on the regulatory changes relating to both investigational and non-investigational medical devices use in trials. The briefing included procedures for regulatory submissions, import controls prior to initiation of trials and safety reporting requirements after the trials have started. The following set of slides were used in these briefing sessions.
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