Ordinary authorization of a medicine with a new active substance (Art. 11 HMG)
Switzerland · Swissmedic · New drugs
Full application, new active substanceHigh confidenceLast verified October 3, 2026
Review target
330 days
official guidance
Legal time limit
-
Not published
Steps
8
13 requirements
Ordinary authorization of a medicine with a new active substance in Switzerland: Steps, Timeline and Fees | DataPorium
Application fee
CHF 80,000
2026
What is the Ordinary authorization of a medicine with a new active substance in Switzerland?
Swissmedic must authorize a ready-to-use medicine before it can be sold in Switzerland. For a new active substance, the applicant submits full data on quality, safety and efficacy, and the agency runs a full scientific review. The first authorization lasts five years. First authorization of a human medicine that contains at least one new active substance. Vaccines, blood products, biotechnology products and gene therapies cannot use the simplified routes, so they also use the full route.
How long does the Ordinary authorization of a medicine with a new active substance take?
The official review target is 330 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 Ordinary authorization of a medicine with a new active substance cost?
The new authorization, human medicine with a new active substance is CHF 80,000 for 2026. A reduced fee of CHF 0 applies in some cases (No fee for an important medicine for a rare disease or a medicine with only a pediatric indication).
What are the steps of the Ordinary authorization of a medicine with a new active substance?
1. Submit the application; 2. Formal control and technical validation (30 days); 3. Applicant corrects formal gaps (clock stopped) (60 days); 4. Evaluation phase I (120 days); 5. Applicant answers the list of questions (clock stopped) (90 days); 6. Evaluation phase II and preliminary decision (90 days); 7. Applicant replies to the preliminary decision (clock stopped) (60 days); 8. Labeling review and official decision (90 days).
Outcome: Authorization for five years. After renewal, the authorization is usually unlimited in time. Valid for 5 years.
Legal basis: Therapeutic Products Act (HMG) Articles 9 to 11 and 16; Therapeutic Products Ordinance (VAM) Articles 3 to 9 and 18
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).
About 480 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.
Steps
In order, with the official target for each step
1. Submit the applicationThe applicant sends the full dossier to the agency.
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 I120 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 decision90 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)60 days, clock stoppedAfter a positive preliminary decision, the applicant sends revised product information and packaging texts.
8. Labeling review and official decision90 daysThe agency checks the revised texts and issues the official decision.
Requirements
What the applicant must provide or meet
Quality and manufacturing
Quality dataResults of physical, chemical, pharmaceutical and biological or microbiological tests, plus the manufacturing method, composition and stability.
Nonclinical data
Pharmacology and toxicology studiesResults of pharmacological and toxicological studies.
Clinical data
Clinical trial resultsResults of clinical studies, including all results from studies in special population groups.
Risk management
Risk management planA risk management plan with a risk assessment and a pharmacovigilance plan is required for a new active substance.
Pediatric
Pediatric investigation planA pediatric investigation plan must be attached, unless the agency grants a waiver or deferral. A plan approved by a comparable foreign authority also meets this duty.
Other
Official time targets
Targets, not actual review times
Validationofficial guidance. Formal control by the agency, in calendar days.
30 days
Longest clock stopofficial guidance. Total applicant time foreseen in the standard procedure.
210 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 up to 210 days of applicant time, is 540 days.
330 days
Fees
Official amounts in the local currency
Fee
Amount
New authorization, human medicine with a new active substanceApplication · 2026 · No fee for an important medicine for a rare disease or a medicine with only a pediatric indication.
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 (32 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
Ten years of data protection
(optional)
The documents for a medicine with at least one new active substance are protected for ten years.
Dossier format: CTD (eCTD, or paper with an electronic copy)The dossier follows the Common Technical Document structure in Modules 1 to 5, with a Swiss Module 1. Electronic eCTD submission is possible; the agency publishes its own eCTD specifications.
Swiss manufacturing, import or wholesale licenseThe applicant also needs a manufacturing, import or wholesale license from the competent authority.
After approval
Official batch release for some products(in some cases)When manufacture needs special safety measures, each batch needs release by the agency before distribution. The agency publishes the list of products concerned.
Report serious adverse reactions within 15 daysThe authorization holder reports serious adverse drug reactions seen in Switzerland within 15 days. Unknown, non-serious reactions are reported within 60 days. Quality defects are reported within 15 days.
Product must reach the market within three yearsThe agency revokes an authorization if the medicine is not actually placed on the market within three years, or if it is off the market for three years in a row.
Renewal after the first five yearsThe renewal application is due at least six months before the five-year authorization ends. A renewed authorization is usually unlimited in time.
Local presence
Applicant based in SwitzerlandThe applicant needs a domicile, registered office or branch in Switzerland. A foreign company usually acts through a Swiss company that holds the authorization.
