Skip to content
ONIX logo blue
  • HOME
  • ABOUT
    • TEAM
  • SERVICES
    • eCTD Submission Management Services
    • Regulatory Advisory Services
    • eCTD MS Word & PDF Formatting
    • eCTD Template Automation
    • Regulatory Affairs Services
    • eSUBMISSION – Expertise
  • eCTD NEWS
    • Testimonials
Menu
  • HOME
  • ABOUT
    • TEAM
  • SERVICES
    • eCTD Submission Management Services
    • Regulatory Advisory Services
    • eCTD MS Word & PDF Formatting
    • eCTD Template Automation
    • Regulatory Affairs Services
    • eSUBMISSION – Expertise
  • eCTD NEWS
    • Testimonials
Contact
ONIX logo blue
Contact
  • HOME
  • ABOUT
    • TEAM
  • SERVICES
    • eCTD Submission Management Services
    • Regulatory Advisory Services
    • eCTD MS Word & PDF Formatting
    • eCTD Template Automation
    • Regulatory Affairs Services
    • eSUBMISSION – Expertise
  • eCTD NEWS
    • Testimonials
Menu
  • HOME
  • ABOUT
    • TEAM
  • SERVICES
    • eCTD Submission Management Services
    • Regulatory Advisory Services
    • eCTD MS Word & PDF Formatting
    • eCTD Template Automation
    • Regulatory Affairs Services
    • eSUBMISSION – Expertise
  • eCTD NEWS
    • Testimonials
etch weekly update image

eCTD Industry Update (15 June 2022)

June 15, 2022
/
onix

EMA:

Regulatory and procedural guideline: Compilation of quality review of documents (QRD) on stylistic matters in product information (updated) - https://bit.ly/3xNMerv

Submitting annual reports on medicine development (updated) - https://bit.ly/3MU0GSR

Changing the name or address of a sponsor (updated) - https://bit.ly/3MJXI3j

Orphans: Regulatory and procedural guidance and forms (updated) - https://bit.ly/3mNjzfG

Other: Procedural advice for post-orphan medicinal product designation activities: guidance for sponsors (updated) - https://bit.ly/3xPMWEK

Transferring an orphan designation (updated) - https://bit.ly/3mMksW0

Regulatory and procedural guideline (updated) - https://bit.ly/34X7Q8K

PreveCTD Industry Update (6 June 2022)
eCTD Industry Update (29 June 2022)Next
  • HOME
  • ABOUT
  • SERVICES
  • eCTD NEWS
  • CONTACT
Menu
  • HOME
  • ABOUT
  • SERVICES
  • eCTD NEWS
  • CONTACT
  • HOME
  • ABOUT
  • SERVICES
  • eCTD NEWS
  • CONTACT
Menu
  • HOME
  • ABOUT
  • SERVICES
  • eCTD NEWS
  • CONTACT
Twitter Linkedin

© Copyright 2026

ONIX Life Sciences Ltd, 59-60 Thames Street, Windsor, Berkshire, SL4 1TX.

ONIX Life Sciences Inc, 500 Delaware Ave, Ste 1 #1960, Wilmington, DE 19899, USA

ONIX Life Sciences Ltd, Salarpuria Sanctity, Kasavanahalli, Sarjapur Road, Bangalore 560035 India

+44 (0) 1753 257 904 | info@onixls.com | www.onixls.com

Privacy Policy

We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.OkPrivacy policy