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eCTD Industry Update (28th September 2022)

September 28, 2022
/
onix

CMDh

  • New - Template for Applicants to Prepare Similarity Report
  • Update - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications (Clean / Tracked Version)
  • Update - RMS validation checklist for human medicinal products in DCP
  • Update - Request for MRP/RUP / Update assessment report
  • Update - CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (Clean / Tracked Version)
  • Update - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
  • New - Overview of timetables 2023 - CMDh 60-day procedures for MRP/DCP applications

FDA

  • Electronic Submission Template for Medical Device 510(k) Submissions

Health Canada 

  • Updated: Guidance document preparation of regulatory activities in non-eCTD format
PreveCTD Industry Update (20th September 2022)
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