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eCTD Industry Update (13th March 2023)

March 13, 2023
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onix

EMA

  • Newsletter: CTIS newsflash - 10 March 2023
  • Other: European Medicines Agency’s data protection notice for the European Union (EU) Metadata Catalogue
  • Other: Orphan medicines figures 2000-2022 (updated)
  • Report: Annual report on the use of the special contribution for orphan medicinal products - 2022
  • Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 January 2023, edition 10)

Health Canada 

  • Health Canada changes filing requirements for product monographs: Notice[2023-03-10]
  • Notice to stakeholders – Clarification of requirements under the Food and Drug Regulations when conducting clinical trials with cannabis[2023-03-09]
  • Consultation period extended until April 26, 2023 for proposed agile regulations and guidance for licensing drugs and medical devices[2023-03-06]
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eCTD Industry Update (20th March 2023)Next
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