Update to the Guideline on the Regulation of Therapeutic Products – Part 11: Clinical trials

Closes 3 Aug 2018

Consultation Contents

Medsafe is seeking comments from parties conducting clinical trials in New Zealand on the updated Clinical Trials regulatory guideline and Clinical Trial Site Notification Form.

You can provide us with feedback on various aspects of the updated guideline and form below. Thank you for participating in this consultation.

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Section 1: Legislation
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Section 2: Overview of regulation of clinical trials in New Zealand
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Section 3: Application for approval of a clinical trial
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Section 4: Notification of clinical trial sites
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Section 5: Good clinical practice requirements
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Section 6: Records and reporting
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General: Layout and format of the guideline
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Clinical Trial Site Notification Form
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Re-notification of clinical trial site
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Your details
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Publishing submissions and privacy (Required)
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Help us improve our consultations
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