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EMA accelerated timelinesWhile researching if the EMA has a timeline/procedure it follows for accelerated Conditional Market Authorization (CMA), the following is what I found. According to this procedure/timeline, CHMP/EMA has to conclude the Novavax approval, the latest by Dec 16. Their constant reminder that Novavax could be approved "within weeks" aligns with these timelines for the accelerated approval on their website. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/submission-dates/procedural-timetables "This page lists the timetables for the submission, start and finish dates of procedures, as well as other interim dates and milestones that occur during the various procedures." https://www.ema.europa.eu/en/documents/other/timetable-accelerated-assessment-request-initial-marketing-authorisation-applications_en.pdf Remember, EMA started evaluating Novavax CMA on Nov 17, 2021, and that is listed as "Start Date" in the above table. Next steps: Monday, Dec 6: Comments from CHMP Thursday, Dec 9: Updated CHMP Joint briefing note Thursday, Dec 16 : CHMP Conclusion And they can always conclude using the "Extraordinary meeting" anytime next week, prior to their regularly scheduled meeting from Dec 13 - Dec 16. |
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Msg # | Subject | Author | Recs | Date Posted |
154088 | Re: EMA accelerated timelines | luckijack | 1 | 12/3/2021 11:04:47 AM |
154089 | Re: EMA accelerated timelines | BillyT | 4 | 12/3/2021 11:08:27 AM |
154098 | Re: EMA accelerated timelines | evsworld | 0 | 12/3/2021 11:26:05 AM |
154161 | Re: EMA accelerated timelines | GlobalHealth | 11 | 12/3/2021 6:11:08 PM |
154202 | Re: EMA accelerated timelines | PSC | 0 | 12/3/2021 11:26:06 PM |