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eCTD Industry Update (25th April 2023)

April 25, 2023
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onix

EMA

  • Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)
  • Template or form: Template for sections A to E for the scientific part of the application for orphan designation (updated)

eSubmissions (eCTD)

Updated PLM Portal eAF timeline now available

  • Please find an updated version of the PLM Portal eAF Human Variations Forms timeline. The slide is also available on the PLM Portal Forum.

CMDh

  • Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures (March 2023) [Track version]
  • Common grounds seen for delaying Day 0 Renewals (March 2023) [Track version]
  • Member State agreement upon conditions under which the RMS can start renewal procedures (March 2023) [Track version]
  • Request for MRP/RUP / Update assessment report (March 2023)
  • Renewals [Track version] (April 2023)
PreveCTD Industry Update (18th April 2023)
eCTD Industry Update (2nd May 2023)Next
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