Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Temporary authorization (incomplete data) (Art. 9a HMG; Art. 18-22 VAZV)

Switzerland · Swissmedic · New drugs

Conditional or accelerated approvalFaster routeHigh confidenceLast verified October 3, 2026

Review target

140 days

official guidance

Legal time limit

Not published

Steps

What is the Temporary authorization (incomplete data) in Switzerland?

For a life-threatening or disabling disease, Swissmedic can authorize a medicine for a limited time before all data are available. A large therapeutic benefit must be expected, and no equivalent alternative may be authorized or available in Switzerland. The authorization lasts at most two years and comes with conditions, such as finishing ongoing studies. Medicines for serious diseases with unmet need, when waiting for complete data in the standard procedure would cause irreversible harm or severe suffering.

How long does the Temporary authorization (incomplete data) take?

The official review target is 140 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.

How much does the Temporary authorization (incomplete data) cost?

The new temporary authorization is CHF 80,000 for 2026.

What are the steps of the Temporary authorization (incomplete data)?

1. Request for a temporary authorization procedure; 2. Accelerated application hearing; 3. Submit the application; 4. Formal control and technical validation (5 days); 5. Applicant corrects formal gaps (clock stopped) (60 days); 6. Evaluation phase I (65 days); 7. Applicant answers the list of questions (clock stopped) (90 days); 8. Evaluation phase II and preliminary decision (50 days); 9. Applicant replies to the preliminary decision (clock stopped) (60 days); 10. Labeling review and official decision (20 days); 11. Fulfil conditions and convert to a regular authorization.

Outcome: Time-limited authorization with conditions. When all conditions are met, the agency grants a regular authorization for five years on request. Valid for 2 years.

Legal basis: Therapeutic Products Act (HMG) Article 9a; Ordinance on Simplified Authorisation (VAZV) Articles 18 to 22

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 346 days end to end with the official step targets, of which up to 210 days are clock stops (time the applicant uses to answer). Targets, not actual times.

Approvals per year, conditional or accelerated approval 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 a temporary authorization procedureThe applicant first asks for the temporary authorization procedure.
2. Accelerated application hearingup to 56 daysA meeting 6 to 8 weeks after the request, where the agency takes a binding decision on the request.
3. Submit the applicationThe application includes interim clinical results that point to a large therapeutic benefit.
4. Formal control and technical validation5 daysThe agency checks that the dossier is complete and formally correct.
5. Applicant corrects formal gaps (clock stopped)60 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 I65 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 decision50 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 decision20 daysThe agency checks the revised texts and issues the official decision.
11. Fulfil conditions and convert to a regular authorizationThe holder completes the required studies. The authorization can be extended on a reasoned request with an interim report.

Requirements

What the applicant must provide or meet

Eligibility

Legal criteria for a temporary authorizationThe disease can lead to severe disability, severe suffering with possible death, or death in the short term. No equivalent alternative is authorized or available in Switzerland. A large therapeutic benefit is expected. The applicant can probably supply the missing data later, and waiting for complete data would cause irreversible harm or severe suffering.

Clinical data

Interim clinical resultsThe application includes interim results of clinical studies that indicate a large therapeutic benefit, and the time needed until a full application.

After approval

Conditions such as completing studiesThe authorization carries special conditions, for example finishing ongoing studies or starting new ones. The product information must show clearly that the authorization is temporary.

Reference approval

Foreign conditional approvals lead only to a temporary authorization(in some cases)If a comparable foreign authority granted only a conditional approval, the agency uses its results only for a temporary authorization.

Local presence

Official time targets

Targets, not actual review times

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 350 days.

140 days

Fees

Official amounts in the local currency

Fee	Amount
New temporary authorizationApplication · 2026	CHF 80,000
Conversion of a temporary authorization into an unlimited authorizationOther · 2026	CHF 500