How medicines and medical devices get approved 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.

Full application, new active substance · target 330 days · verified October 3, 2026

This route covers a medicine whose active substance is already in a medicine authorized in Switzerland, but which brings something new, such as a new indication, dosage form, strength or route. The applicant refers to the reference product for the known parts and gives full data for the new parts.

Full or mixed application, known active substance · target 330 days · verified October 3, 2026

If a medicine is already authorized in a country with comparable medicines control, Swissmedic takes the results of that country's review into account. For known active substances and for biosimilars authorized in the EU or the US, the agency does no scientific review of its own. For new active substances, it still runs a full review but can reduce it in justified cases.

Reliance route, abridged review · target 195 days · relies on AU, CA, EU, GB, JP, SG, US · verified October 3, 2026

Swissmedic can review a human medicine, or a change to one, faster when it promises to prevent or treat a severe, disabling or life-threatening disease, when treatment options are missing or unsatisfactory, and when a high therapeutic benefit is expected. The applicant first needs an approved fast-track request. The data required are the same as in the standard procedure.

Priority or accelerated review · target 140 days · verified October 3, 2026

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.

Other route · target 264 days · verified October 3, 2026

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.

Conditional or accelerated approval · target 140 days · verified October 3, 2026

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.

Orphan or rare disease designation · target 210 days · relies on EU, US · verified October 3, 2026

A medicine can be authorized in a simplified way when its active substances have been used for at least ten years in a medicine authorized in at least one EU or EFTA country, and the product is comparable in indication, dosage and route. Evidence on safety and efficacy can be bibliographic. The fee is 70 percent lower.

Well-established use · target 330 days · relies on EU · verified October 3, 2026

Herbal medicines and complementary medicines can be authorized in a simplified procedure. Efficacy and safety can be shown with bibliographic evidence or proof of use. Complementary medicines without an indication whose ingredients are on official lists can be placed on the market after a notification.

Traditional or herbal registration · target 120 days · verified October 3, 2026

A second distributor can get a simplified authorization for a medicine already authorized in Switzerland and imported from a country with an equivalent authorization system. The imported product must meet the same requirements as the Swiss product, including labeling and product information, with some simplifications.

Other route · target 330 days · verified October 3, 2026

Swissmedic can allow, for a limited time, the use of an investigational medicine in specific persons or groups outside clinical trials. It can also allow a time-limited or quantity-limited supply of a medicine to bridge a temporary shortage of an identical Swiss product, if the medicine is authorized in a country with comparable control and no essentially similar product is authorized and available.

Early or compassionate access · verified October 3, 2026

Applications for a new active substance, an orphan medicine with a new substance, or a new indication, form or route of such products must include a pediatric investigation plan. A plan approved by a comparable foreign authority is accepted. Medicines developed only for children can get ten years of data protection, and their authorization fee is waived.

Pediatric plan or incentive · verified October 3, 2026

A biosimilar is a biological medicine that is sufficiently similar to a reference product authorized in Switzerland and refers to its documentation. Biotechnology products cannot use the simplified route, so a biosimilar needs full quality data and comprehensive comparability studies. If the European Commission or the US FDA has already authorized the same biosimilar, the agency can rely on that decision.

Biosimilar application · target 330 days · relies on EU, US · verified October 3, 2026

A generic is authorized in a simplified procedure. Its indication, form, strength, route and dosage, and its quality, efficacy and safety, are all based on a reference product already authorized in Switzerland. Efficacy and safety are usually shown through therapeutic equivalence or bioavailability studies.

Generic application · target 330 days · verified October 3, 2026

A non-prescription medicine with an indication can be authorized in a simplified way if it has been in medical use for at least 30 years, including at least 15 years in EU and EFTA countries. Pharmacology, toxicology and clinical documentation can be left out, but the leaflet states that the agency did not check safety and efficacy. The fee is 70 percent lower.

Well-established use · target 330 days · relies on EU · verified October 3, 2026

There is no separate route for non-prescription medicines. When Swissmedic authorizes a medicine, it assigns a dispensing category: A and B need a prescription, D is dispensed after expert advice, and E is free sale. The holder can ask the agency to move a medicine to another category.

Non-prescription application · target 270 days · verified October 3, 2026

For medical devices, including software, the manufacturer classifies the device under the EU MDR rules, runs the conformity assessment set out in the EU MDR, using a designated body where required, and declares conformity before placing it on the market. Certificates from EU or EEA notified bodies are accepted. A manufacturer outside Switzerland needs a Swiss authorized representative.

Device: conformity assessment by a certification body · relies on EU · verified October 3, 2026

Manufacturers or their Swiss authorized representatives, and importers, register with Swissmedic before first placing a device on the market and receive a Swiss registration number (CHRN). Since July 2026, devices themselves must also be registered with the agency, with a six-month transition period.

Device: registration or licence with the regulator · verified October 3, 2026

On a reasoned request, Swissmedic can allow a specific device to be placed on the market even though the required conformity assessment was not done, if its use is in the interest of public health or patient safety. In single cases, a health professional may also use a non-conforming device for a life-threatening condition without a permit, under strict conditions including informed consent.

Early or compassionate access · verified October 3, 2026

In vitro diagnostic devices, including diagnostic software, follow the EU IVDR rules as taken over in the Swiss ordinance. The manufacturer classifies the product in classes A to D, runs the conformity assessment with a performance evaluation, and declares conformity. Certificates from EU or EEA notified bodies are accepted. A manufacturer outside Switzerland needs a Swiss authorized representative.

Device: conformity assessment by a certification body · relies on EU · verified October 3, 2026