Procedure with prior notification (20 percent shorter review for a double fee) (Art. 7 GebV-Swissmedic)
Switzerland · Swissmedic · New drugs
Other routeFaster routeHigh confidenceLast verified October 3, 2026
Review target
264 days
official guidance
Legal time limit
-
Not published
Steps
Procedure with prior notification (20 percent shorter review for a double fee) in Switzerland: Steps, Timeline and Fees | DataPorium
10
6 requirements
Application fee
-
What is the Procedure with prior notification (20 percent shorter review for a double fee) in Switzerland?
Companies can ask Swissmedic to reserve review resources in advance so that an application is processed within a timeframe 20 percent shorter. In return, the fee doubles. It is a service, not a legal right, and it does not reduce the data requirements. First authorization of a new active substance, of a known substance that cannot use the simplified route, or a new indication for such a product, when all studies are complete at submission.
How long does the Procedure with prior notification (20 percent shorter review for a double fee) take?
The official review target is 264 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
What are the steps of the Procedure with prior notification (20 percent shorter review for a double fee)?
1. Request for the procedure; 2. Agency decides on the requested date (30 days); 3. Submit the application on the agreed date; 4. Formal control and technical validation (10 days); 5. Applicant corrects formal gaps (clock stopped) (10 days); 6. Evaluation phase I (100 days); 7. Applicant answers the list of questions (clock stopped) (90 days); 8. Evaluation phase II and preliminary decision (90 days); 9. Applicant replies to the preliminary decision (clock stopped) (60 days); 10. Labeling review and official decision (64 days).
Outcome: Same authorization as in the standard procedure, after a shorter review.
About 444 days end to end with the official step targets, of which up to 160 days are clock stops (time the applicant uses to answer). Targets, not actual times.
Approvals per year, other route in Switzerland
From the official approvals data of this market, all products of this pathway type and segment
Steps
In order, with the official target for each step
1. Request for the procedureSent at the earliest six months and at the latest three months before the planned submission date.
2. Agency decides on the requested date30 daysThe agency says whether it can run the procedure on the proposed date, or suggests another date.
3. Submit the application on the agreed dateThe dossier is submitted in CTD format, as eCTD or paper with an electronic copy.
4. Formal control and technical validation10 daysThe agency checks that the dossier is complete and formally correct.
5. Applicant corrects formal gaps (clock stopped)10 days, clock stopped, only in some casesIf the dossier has formal gaps, the applicant gets time to correct them. The agency does not process an application that stays incomplete.
6. Evaluation phase I100 daysScientific review. It ends with a list of questions to the applicant, if there are questions.
7. Applicant answers the list of questions (clock stopped)90 days, clock stopped, only in some casesApplicant time to answer the questions.
8. Evaluation phase II and preliminary decision90 daysThe agency reviews the answers and sends a preliminary decision, which can be positive or negative.
9. Applicant replies to the preliminary decision (clock stopped)60 days, clock stoppedAfter a positive preliminary decision, the applicant sends revised product information and packaging texts.
10. Labeling review and official decision64 daysThe agency checks the revised texts and issues the official decision.
Requirements
What the applicant must provide or meet
Eligibility
Eligible application typesFirst authorization of a new active substance, first authorization of a known substance product that cannot use the simplified route, or an additional indication for such a product.
Clinical data
All studies complete at submissionClinical and preclinical studies should be fully completed when the application is submitted. Further study data cannot be added later in the procedure.
Reference approval
Foreign assessment reports includedAny foreign assessment results available to the applicant, in particular EMA or FDA assessment reports, must be included.
Other
Dossier format: CTD, as eCTD or paper with electronic copyThe procedure is only possible for a CTD dossier in eCTD format or on paper with an electronic copy.
Fees doubleThe authorization fees are doubled in exchange for the shorter review time.
Local presence
Official time targets
Targets, not actual review times
Longest clock stopofficial guidance. Total applicant time foreseen in this procedure.
160 days
Review targetofficial guidance. Official target for agency time only, counted in calendar days. Time the applicant takes to answer is not counted. Actual review times can differ. The maximum total, including applicant time, is 424 days.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
Applicant based in Switzerland
The applicant needs a domicile, registered office or branch in Switzerland. A foreign company usually acts through a Swiss company that holds the authorization.
