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

Orphan drug status (important medicine for a rare disease) (Art. 4 Abs. 1 Bst. adecies HMG; Art. 4-5 VAZV)

Switzerland · Swissmedic · New drugs

Orphan or rare disease designationHigh confidenceLast verified October 3, 2026

Review target

210 days

official guidance

Legal time limit

Not published

Steps

5 requirements

What is the Orphan drug status (important medicine for a rare disease) in Switzerland?

Swissmedic grants orphan drug status to a human medicine for a life-threatening or chronically disabling disease that affects at most 5 in 10,000 people in Switzerland, or when a comparable foreign authority has already granted orphan status. Status brings a waived authorization fee, a simplified procedure and up to 15 years of data protection. Before or together with the authorization application for a rare disease medicine.

How long does the Orphan drug status (important medicine for a rare disease) take?

The official review target is 210 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 Orphan drug status (important medicine for a rare disease) cost?

The recognition of orphan drug status (human medicine) is CHF 3,000 for 2026.

What are the steps of the Orphan drug status (important medicine for a rare disease)?

1. Apply for orphan drug status; 2. Formal control and technical validation (30 days); 3. Applicant corrects formal gaps (clock stopped) (60 days); 4. Evaluation phase I (90 days); 5. Applicant answers the list of questions (clock stopped) (90 days); 6. Evaluation phase II and preliminary decision (60 days); 7. Applicant replies to the preliminary decision (clock stopped) (90 days); 8. Decision on orphan status (30 days).

Does the Orphan drug status (important medicine for a rare disease) rely on other regulators?

Yes. It relies on approvals from European Union, United States (recognition, recognition).

Outcome: Orphan drug status, which can carry conditions.

Legal basis: Therapeutic Products Act (HMG) Articles 4, 11b and 14; Ordinance on Simplified Authorisation (VAZV) Articles 4, 5 and 24 to 26

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 390 days end to end with the official step targets, of which up to 240 days are clock stops (time the applicant uses to answer). Targets, not actual times.

Steps

In order, with the official target for each step

1. Apply for orphan drug statusThe application can be filed at any time during development or together with the authorization application.
2. Formal control and technical validation30 daysThe agency checks that the dossier is complete and formally correct.
3. 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.
4. Evaluation phase I90 daysScientific review. It ends with a list of questions to the applicant, if there are questions.
5. Applicant answers the list of questions (clock stopped)90 days, clock stopped, only in some casesApplicant time to answer the questions.
6. Evaluation phase II and preliminary decision60 daysThe agency reviews the answers and sends a preliminary decision, which can be positive or negative.
7. Applicant replies to the preliminary decision (clock stopped)90 days, clock stoppedAfter a positive preliminary decision, the applicant sends revised product information and packaging texts.
8. Decision on orphan status30 daysThe agency grants the status if the criteria are met.

Requirements

What the applicant must provide or meet

Eligibility

Rare and serious diseaseThe disease is life-threatening or chronically disabling and affects at most 5 in 10,000 people in Switzerland at the time of the application, shown with reference documents and literature.

Reference approval

Or orphan status from a comparable country(in some cases)Alternatively, the status can rest on orphan status granted abroad. The applicant then submits all decisions on orphan status from other comparable countries.

Other

Separate application for a rare-disease indication(in some cases)For a new indication of an authorized medicine, the holder files a separate application that covers only the rare-disease indications.
Simplified authorization and adapted data needs(optional)A medicine with orphan status can be authorized in a simplified procedure. The agency takes the rarity of the disease into account when setting data requirements, and the dossier from a comparable country can be submitted.
Fifteen years of data protection on request(optional)For an important medicine for a rare disease, the agency grants 15 years of data protection on request.

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 450 days.

210 days

Fees

Official amounts in the local currency

Fee	Amount
Recognition of orphan drug status (human medicine)Designation · 2026 · After status is granted, no fee is charged for the new authorization.	CHF 3,000

Reliance on other regulators

European UnionRecognitionOrphan status granted in a comparable country can be the basis for Swiss status. A reduced review of the authorization application under the foreign-authorization procedure is possible only for products designated by the EMA orphan committee or under the US Orphan Drug Act, with identical indication wording and Swiss status approved first.
United StatesRecognitionOrphan status granted in a comparable country can be the basis for Swiss status. A reduced review of the authorization application under the foreign-authorization procedure is possible only for products designated by the EMA orphan committee or under the US Orphan Drug Act, with identical indication wording and Swiss status approved first.