Bonjour, On est tous déçu par l’annonce du jour, néanmoins ne cédons pas à la panique, j’ai repris les rapports CHMP de mars 2022 a février 2023 et j’ai retrouvé 12 médicaments étant dans la rubrique 2.1 pour une oral explanation mais au final ne participant pas a une Oral explanation pour je cite « The CHMP agreed that an oral explanation was not needed at this time » mais au final se retrouvant avec une nouvelle liste de questions supplémentaires, sur ces 12 medicaments, 11 obtiennent une autorisation principalement dans les 3,4 mois qui suivent, 1 ne l’obtient pas, motif de refus : « pas d’etude randomisé » ce qui n’est pas le cas pour AB …
Donc, oui on attend, oui les délais sont longs, mais rappelons-nous que c’est pour mettre en vente une nouvelle molécules, via une entreprise qui n’est pas encore une pharmacie.
Ci-dessous le détail de mes recherches, source : minutes des CHMP,
Nom du médicament ou molécule
Premier paragraphe : rubrique 2.1
Deuxième paragraphe : rubrique 3.2 pour le même médicament
Décisions du CHMP
CHMP MAR 2022
Budesonide
Action: Oral explanation to be held on 23 March 2022 at 11:00
List of Outstanding Issues adopted on 27.01.2022. List of Questions adopted on 14.09.2021.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 27.01.2022. List of Questions adopted on 14.09.2021.
The Committee was reminded of the status of this application and its remaining outstanding issues.
See 2.1
The CHMP agreed that an oral explanation was not needed at this time.
The Committee adopted a 2nd list of outstanding issues with a specific timetable.
Opinion adopted
19/05/2022
Marketing authorisation issued
15/07/2022
CHMP MAY 2022
melphalan flufenamide
Action: Possible oral explanation to be held on 17 May 2022 at 14:00
List of Outstanding Issues adopted on 24.03.2022. List of Questions adopted on 16.09.2021.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 24.03.2022. List of Questions adopted on 16.09.2021.
See 2.1
The Committee was reminded of the status of this application and its remaining outstanding issues.
The CHMP agreed that an oral explanation was not needed at this time.
The Committee adopted a 2nd list of outstanding issues with a specific timetable.
Marketing authorisation issued
17/08/2022
Tezepelumab
Action: Possible oral explanation to be held on 17 May 2022 at 16:00
List of Outstanding Issues adopted on 24.03.2022. List of Questions adopted on 14.10.2021.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 24.03.2022. List of Questions adopted on 14.10.2021.
See 2.1
The Committee was reminded of the status of this application and its remaining outstanding issues.
The CHMP agreed that an oral explanation was not needed at this time.
The Committee adopted a 2nd list of outstanding issues with a specific timetable.
Marketing authorisation issued
19/09/2022
CHMP JUN 2022
Maribavir
Action: Oral explanation to be held on 21 June 2022 at 14:00
List of Outstanding Issues adopted on 22.04.2022. List of Questions adopted on 14.10.2021.
An oral explanation was held on 21 June 2022. The presentation by the applicant focused on the clinical data in support of the application.
See 3.2
List of Outstanding Issues adopted on 22.04.2022. List of Questions adopted on 14.10.2021.
See 2.1
The CHMP agreed that an oral explanation was not needed at this time.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The Committee adopted a 2nd list of outstanding issues with a specific timetable.
Marketing authorisation issued
09/11/2022
Fosdenopterin
Action: Oral explanation to be held on 22 June 2022 at 15:30
List of Outstanding Issues adopted on 20.04.2022. List of Questions adopted on 22.02.2022.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 20.04.2022. List of Questions adopted on 22.02.2022.
See 2.1
The CHMP agreed that an oral explanation was not needed at this time.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The Committee adopted a 2nd list of outstanding issues with a specific timetable.
Marketing authorisation issued
15/09/2022
CHMP JUL 2022
Mitapivat
Action: Oral explanation to be held on 20 July 2022 at 17:00
List of Outstanding Issues adopted on 19.05.2022, 24.03.2022. List of Questions adopted on 11.11.2021.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 19.05.2022, 24.03.2022. List of Questions adopted on 11.11.2021.
See 2.1
The CHMP agreed that an oral explanation was not needed at this time.
The Committee was reminded of the status of this application and its remaining outstanding issues. The Committee adopted a 3rd list of outstanding issues with a specific timetable.
The CHMP agreed on the need to consult the non-clinical working party (NcWP) and adopted a list of questions to this group.
Marketing authorisation issued
09/11/2022
CHMP SEPT 2022
Spesolimab
Action: Oral explanation to be held on 14 September 2022 at 14:00
List of Outstanding Issues adopted on 21.07.2022. List of Questions adopted on 24.02.2022.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 21.07.2022. List of Questions adopted on 24.02.2022.
See 2.1
The CHMP agreed that an oral explanation was not needed at this time.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The Committee adopted a 2nd list of outstanding issues with a specific timetable.
Marketing authorisation issued
09/12/2022
CHMP OCT 2022
iodine (131I) omburtamab
Action: Possible oral explanation to be held on 11 October 2022 at 14:00
List of Outstanding Issues adopted on 23.06.2022. List of Questions adopted on 16.09.2021.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 23.06.2022. List of Questions adopted on 16.09.2021.
See 2.1
The CHMP agreed that an oral explanation was not needed at this time.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The Committee adopted a 2nd list of outstanding issues with a specific timetable.
Refusal of marketing authorisation
12/04/2023
As the main study did not have a randomised comparator, it was not possible to determine a treatment effect.
CHMP NOV 2022
Miglustat
List of Outstanding Issues adopted on 15.09.2022. List of Questions adopted on 24.03.2022.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 15.09.2022. List of Questions adopted on 24.03.2022.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The CHMP agreed that an oral explanation was not needed at this time.
See 2.1
The Committee adopted a 2nd list of outstanding issues with a specific timetable.
Marketing authorisation issued
26/06/2023
Cipaglucosidase
Action: Oral explanation to be held on 09 November 2022 at 09:00
List of Outstanding Issues adopted on 15.09.2022. List of Questions adopted on 24.03.2022.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 15.09.2022. List of Questions adopted on 24.03.2022.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The CHMP agreed that an oral explanation was not needed at this time.
See 2.1
The Committee adopted a 2nd list of outstanding issues with a specific timetable.
Marketing authorisation issued
20/03/2023
CHMP DEC 2022
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CHMP JANV 2023
Pegunigalsidase
Action: Oral explanation to be held on Tuesday 24 January 2023 at 09:00
List of Outstanding Issues adopted on 10.11.2022. List of Questions adopted on 23.06.2022.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 10.11.2022. List of Questions adopted on 23.06.2022.
See 2.1
The Committee was reminded of the status of this application and its remaining outstanding issues.
The CHMP agreed that an oral explanation was not needed at this time.
The Committee adopted a 2nd list of outstanding issues with a specific timetable.
Marketing authorisation issued
04/05/2023
CHMP FEV 2023
Camzyos
Action: Oral explanation to be held on 22 February 2023 at 16:00
List of Outstanding Issues adopted on 15.12.2022, 21.07.2022. List of Questions adopted on 27.01.2022.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
List of Outstanding Issues adopted on 15.12.2022, 21.07.2022. List of Questions adopted on 27.01.2022.
See 2.1
The CHMP agreed that an oral explanation was not needed at this time.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The Committee adopted a 3rd list of outstanding issues with a specific timetable.
Marketing authorisation issued
26/06/2023
