Sunday, December 31, 2023 6:43:46 AM
The MHRA’s assessment (and clock) does not start until the application has been validated. Regulatory Agencies first perform a technical validation of the marketing application to ensure that all of the essential elements that are required for scientific assessments are included, and that these elements are all organized and located according to the standard electronic Common Technical Document (eCTD) format. While it is true that the marketing application has been submitted by Northwest Bio, and received by the MHRA, it has not been “officially accepted” yet. And by the way, no they don’t “hand it back to the company” or “throw it in the trash” (it’s digital) but if the MHRA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a certain deadline.
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