Fast-track application procedure

What happens if the company is unable to submit the responses by the communicated time point and submits later (during a fast-track procedure)?

In this case Swissmedic will start the review of the responses as soon as possible (depending on the available resources), but at the latest after the 90 days, which is the maximum time for responding to the LoQ, for fast-track procedures for new MAA. Note: Even if a pre-arranged deadline cannot be met, the MAA is subsequently still reviewed according to the fast-track timelines (i.e., 50 days for Evaluation phase II, 20 days for review of answers to pre-approval).

What is the amount of time allowed for the applicant to respond to the pre-decision (PD)?

The maximum response time to the pre-decision (PD) is. 60 days. To ensure that responses are processed promptly, the applicant must also inform Swissmedic, in advance, of the submission date of the responses to the preliminary decision. Communication of this date has to occur within 14 calendar days after the date of the PD.

Your contact

Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
Send email


 

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