Winst gevend schreef op 22 april 2024 17:08:
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Email responce EMA.Thank you for writing to the European Medicines Agency to ask about the status of leniolisib.
As you are aware, this medicine is under evaluation by EMA’s human medicines committee, the CHMP.
The assessment started on the 27/Oct/2022.
In practice, an evaluation of marketing authorisation generally takes around one year
but can take longer if the CHMP requires more clarification or data from the company.
In the case of leniolisib the CHMP adopted a list of questions on 24 January 2023.
This means that the clock has now stopped while the company is preparing answers to the questions of the CHMP.
The medicine will be rediscussed at CHMP when the company has provided its answers.
We would like to assure you that the Agency is committed to carry out its assessment as quickly as possible all while ensuring that the data provided sufficiently show that the benefits of the medicine outweigh the risks.
We would also like to point out that EMA and FDA are two independent regulatory authorities who carry out evaluations based on an applicant’s application to the respective agency.
It is up to the applicant to decide when to make an application.
Although there is cooperation between EMA and FDA, the evaluations are carried out independently
by each agency, following the existing legislation in either the EU or the US.
We hope you find this information useful.
Kind regards,
m.a.w. weten we nu nog steeds niet wat het knelpunt is, maar ik wilde het wel even met jullie delen.
Fijne dag verder.