Module 1 2021

25/06/2021

Recommended references

• Canada • http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic- demande/guide-ld/ectd/index-eng.php • Switzerland • https://www.swissmedic.ch/swissmedic/en/home/services/submis sions/ectd.html • Other Regions – Australia • https://www.tga.gov.au/electronic-submissions • Other Regions – Saudi Arabia and Oman • https://www.sfda.gov.sa/en/drug/drug_reg/Regulations/Baseline_ eCTD_Requirement.pdf • https://www.moh.gov.om/documents/16539/0/eCTD+Guideline+v ersion+2/3ffef6fe-65c2-4dd2-8c1c-5d381b0e5e2b

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Recommended references

• Other Regions – South Africa • http://www.mccza.com/Publications/Index/1

• Other Regions – Thailand • http://www.fda.moph.go.th/sites/FDA_EN/Pages/Main.aspx

• ASEAN CTD Specification • https://asean.org/?static_post=asean-common-technical-dossier- actd

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