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eCTD Industry Update (08 August 2022)

August 9, 2022
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EMA

  • Newsletter: News bulletin for small and medium-sized enterprises - Issue 56

eSubmissions (eCTD)

  • Questions and Answers document from the public webinar “DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live” held on 12th July 2022

            The Q&A document from the public webinar is now available.

CMDh

  • UPDATE - EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (Clean Version) (July 2022) [Track version]

  • UPDATE - Chapter 7: CMDh BPG on Worksharing give this link clean and tracked EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (July 2022) (Clean Version / Tracked Version)

  • CMS Validation Checklist for human medicinal products in DCP (July 2022)

  • RMS Validation Checklist for human medicinal products in DCP (July 2022)

  • UPDATE - Procedural advice on Validation of MR/Repeat-use/DC Procedures (July 2022) (Clean Version / Tracked Version)

  • UPDATE - Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures (July 2022) (Clean Version / Tracked Version)

  • UPDATE - Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure (July 2022) (Clean Version / Tracked Version)

Health Canada

  • Notice: Revision to the Guidance Document Management of Drug Submissions and Applications (August 2022) [2022-08-02]

  • Notice: Revisions to the performance standards for Post-authorization Division 1 Changes [2022-08-02]

  • Updated: Guidance Document Post-Drug Identification Number (DIN) Changes [2022-08-02]

PreveCTD Industry Update (02 August 2022)
eCTD Industry Update (22nd August 2022)Next
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