Documents

IMDRF documents support regulatory harmonization and convergence of IMDRF.

Please note that Working Group Chairs and Members requiring access to the current IMDRF documentation templates should email requests to the Secretariat at imdrf2022 [at] tga.gov.au

List of links to various types of documents

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Technical documents

Final documents produced by a working group
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GHTF final documents

Final documents created by the Global Harmonization Task force (GHTF) that are still current.
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Procedural documents

Operational planning and guidance
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Information documents

Reference material for IMDRF members
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Meeting outcome statements

Official meeting summaries including MC decisions
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GHTF archives

Historical information and archived documents produced by the Global Harmonization Task Force (GHTF)

Latest technical documents

View all technical documents

Meeting outcome statements

Meeting no: 22

Australia Virtual Meeting outcome statement

Meeting no: 21

Australia Virtual Meeting outcome statement

Meeting no: 20

Korea Virtual Meeting outcome statement

Meeting no: 19

Korea Virtual Meeting outcome statement

Meeting no: 18

Singapore Virtual Meeting outcome statement

Meeting no: 17

Closed session management committee meeting outcome statement

View all outcome statements

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

World Health Organization (WHO)