April – May news updates from HMA and CMDv

11 May, 2017

The latest CMDv Report for release, giving an overview of the activities of the February and March 2017 meetings, is available to view and download (Link). The report includes amongst other items:

  • Endorsement of the CMDv multiannual work plan 2017 -2020 (Link)
  • Handling of unforeseen variations – Deletion of a manufacturing process from the drug product manufacturing processes. Full details can be found in the CMDh Excel tracker for unforeseen variation classifications (Link).
  • Responses to questions from Industry:
    • Re-registration after Sunset Clause
    • Generic Variation of Originator
  • Clarification of implementation dates for variations

In addition to the Report for Release, there have been a number of other developments:

  • Updated list of CMDv members and their qualifications (Link)
  • CMDv GUI-22 and GUI-23 (format and number of copies required by NCAs) and GUI-25 (payment terms and addresses), as well as the record of additional national requirements have been updated (Link)
  • A new Q & A document has been published: Q & A 231 – Global Marketing Authorisation – Protection period (Link)
  • The HMA has formed a new Regulatory Optimisation Group (ROG), which is focused on optimising regulatory and business operations and reducing regulatory burden (Link). In 2017, the ROG will focus on type IA variations.
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