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Protects the rights and welfare of individuals participating in research to ensure ethical research is being conducted

CTC - apply together with IRB

CTN - must apply IRB first then CTN

CTA - apply IRB at the same time

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Health Products Supplement

Chinese Proprietary Medicines

Regulated by Medicines Act & Medicines (Clinical Trials) Regulations

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General Sales List

Pharmacy Only

Prescription Only Meds

Regulated by Health Products Act & Health products

(Clinical Trials) Regulations

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class 2 CTGTP (Cell, tissue and gene therapy products)

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class 2 CTGTP (Cell, tissue and gene therapy products)

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Regulated as they are of higher risk than class 1

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Observational clinical trials

Medical devices

Class 1 CTGTP

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locally unregistered TP and class 2 CTGTP

unapproved use of a locally registered TP and class 2 CTGTP

registered but using for a new indication

new dosage forms

new dosing regime

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registered products with approved labels

Involves only locally registered TP and class 2 CTGTP

Clinical research materials must be pre-approved

Placebos

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For medicinal products (e.g. CPM)

if CRM is required, will be in same CTC application

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Required to comply with the requirements of the Human Biomedical Research Act

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Required to comply with the requirements of the Human Biomedical Research Act

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Registered /Unregistered health products that are being used in the clinical research

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Therapeutic products

Class 1 CTGTP (manufactuere/importer/wholesaler notification has not been made to HSA)

Class 2 CTGTP

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Medicinal products

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Medical Devices

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Health Products (CRM) Regulations

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Medicines (Medicinal Products as CRM) Regulations

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Health Products (Medical Devices) Regulations