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eCTD Industry Update (15 June 2022)

June 15, 2022
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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
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