The latest CMDv Report for release, giving an overview of the activities of the July and September 2016 meetings, is available to view and download (Link). The report includes amongst other items the outcome of discussions on subjects such as biowaivers for hybrids, generic applications where the reference product is no longer available on the market for bioequivalence studies, changes to active substance specifications in response to a new CEP or changes to an ASMF, divergent worksharing opinions leading to referrals, MUMs guidance for IVMPs, and a proposed move to VNees-only electronic submissions for all veterinary application dossiers.
Minutes of the Interested Parties meetings which took place in May 2016 were adopted and published (Link).
CMDv meeting dates for 2017-2018 were published (Link).
Documents containing fee payment information (Link), contact details and delivery addresses for the National Authorities (Link to Excel document) were also updated.
Regulatory Outsourcing Options
Cyton’s dedicated regulatory procedures team can support you with:
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- Key person cover
- Pharmacovigilance
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