January 24, 2011 InterbrandHealth recently learned that the European Medicines Agency (EMA), the agency responsible for the evaluation of medicines developed by pharmaceutical and biotechnology companies for use in the European Union, has issued procedural changes in regards to name submissions. Historically, in order to allow adequate time for the review of proposed names, the EMA had designated two deadlines for each Name Review Group (NRG) meeting. (NRG meetings are where name submissions are assessed and either approved or rejected.) For both deadlines, applicants had the opportunity to either submit new names or resubmit names that had previously been rejected by the EMA. Now, the EMA has redefined what can be submitted for each of the two deadlines: •
Deadline 1 is now reserved only for new name submissions
Deadline 2 is now reserved only for justifications to support the resubmission of name
Those of us in the health & life sciences industry should be advised that EMA review of proposed names is now even more structured and specific as a result of these policy changes. Given these recent developments, we may need to anticipate adjusting planned timelines for name submissions in the precommercial phase. If you have any questions or concerns regarding these changes and how they might impact future name submissions at your organization, please feel free to contact John Breen, InterbrandHealth’s Senior Director of Analytics, at firstname.lastname@example.org.
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Published on Jan 26, 2011