ICH guideline E8 (R1) on general considerations for clinical studies

Name: ICH guideline E8 (R1) on general considerations for clinical studies
Creator: Therapeutic Goods Administration
Keywords: australia,clinical-studies,considerations,guidelines,scientific

Information

Original link

Type

International scientific guidelines adopted in Australia

Regulated products

Medical Devices

Topics

Clinical Trials, Prescription Medicines, Therapeutic Goods Regulation

Published

July 17, 2024

Last updated

July 17, 2024

Description

We have adopted this International Scientific Guideline - ICH E8 (R1); EMA/CHMP/ICH/544570/1998 Corr*

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

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2 Main files

ICH guideline E8 (R1) on general considerations for clinical studies

Updated on July 17, 2024

pdf

URL: https://www.tga.gov.au/sites/default/files/2024-07/International-Scientific-Guideline-ICH-guideline-E8-R1-general-considerations-clinical-studies-adopted.PDF
Permalink: https://data.openrid.co/en/datasets/r/9109d170-7936-49cf-898e-dda4a486b914
MIME Type: application/pdf

Created on: July 17, 2024
Modified on: July 17, 2024

ICH guideline E8 (R1) on general considerations for clinical studies

Updated on July 17, 2024

html

URL: https://www.tga.gov.au/resources/resource/international-scientific-guidelines/ich-guideline-e8-r1-general-considerations-clinical-studies
Permalink: https://data.openrid.co/en/datasets/r/93573aee-4f87-4b9a-afd9-7377695afadf
MIME Type: text/html

Created on: July 17, 2024
Modified on: July 17, 2024

ICH guideline E8 (R1) on general considerations for clinical studies

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Regulated products

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Last updated

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Country / Region

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