569-day submission gap: why innovative medicines reach Switzerland later

Swissmedic reviews competitively, but late filing, pricing and reimbursement extend the path to routine patient access

Innovative medicines often reach patients in Switzerland later than in major reference markets, but the decisive delay is not caused by regulatory review alone. For new active substances authorised by Swissmedic in 2025, the median interval between the first filing with an international reference authority and filing in Switzerland was 569 days. The entire access chain therefore matters: global submission strategy, Swiss authorisation, pricing, inclusion in the List of Pharmaceutical Specialities and operational supply readiness.

The bottleneck starts before Swiss authorisation

The submission gap is the interval between the first regulatory filing in an international market and the later submission to Swissmedic. According to Swissmedic's international analysis for 2025, this gap had a median of 569 days for newly authorised active substances. In most cases, the dossier was first filed with the US FDA.

The Swissmedic Benchmarking Study 2025 shows the same structural effect from another comparison: the submission gap for new active substances was 362 calendar days versus the EMA and 405 days versus the FDA. The studies use different methods and comparison groups, but both show that much of the lost time accumulates before the Swiss authority can even begin its assessment.

Swissmedic reviews competitively by international standards

Swissmedic authorised 40 human medicines with new active substances in 2025. In the international CIRS analysis, the overall processing time for the included procedures was 413 days, compared with 448 days at the EMA. The core scientific assessment, including company response time, took 303 days. The national benchmarking study reports a median throughput time of 392 days across all 40 authorisations.

The figures are not directly interchangeable because the studies define their samples differently. They nevertheless show that simply blaming a slow Swiss regulator is misleading. The larger opportunity lies in earlier filing, selecting the right procedure and connecting regulatory and commercial market access.

From submission gap to access gap

A marketing authorisation makes a medicine legally marketable, but does not yet guarantee routine reimbursement by mandatory health insurance. This usually requires inclusion in the Federal Office of Public Health's List of Pharmaceutical Specialities. Effectiveness, appropriateness and cost-effectiveness are assessed separately and a reimbursable price is determined.

Four stages to routine patient access

Global prioritisation and filing: the company decides when Switzerland enters the international submission sequence.
Swissmedic authorisation: quality, safety and efficacy are assessed under the Swiss Therapeutic Products Act and the applicable ordinances.
Pricing and reimbursement: the Federal Office of Public Health decides on inclusion in the List of Pharmaceutical Specialities; the application may be submitted before the Swissmedic authorisation is granted.
Launch and supply: stock, product data, distribution routes and robust demand planning turn formal access into practical availability.

Outside routine listing, reimbursement may be considered in justified individual cases under Articles 71a to 71d of the Health Insurance Ordinance. That route is not an equivalent substitute for predictable and consistent access through the List of Pharmaceutical Specialities.

The List of Pharmaceutical Specialities remains a central access step

The Federal Office of Public Health reported a record for 2025: 39 new medicines and 52 new indications reached routine reimbursement. At the same time, the federal authorities acknowledge further scope for acceleration and are working on reforms to pricing, access and supply.

A complementary industry-funded analysis based on the EFPIA Patients W.A.I.T. Indicator 2025 reviewed 168 medicines authorised in Europe between 2021 and 2024. It reports that around 50 per cent were routinely available in Switzerland through the List of Pharmaceutical Specialities, 27 per cent had only limited access through individual reimbursement and just under one quarter were unavailable. These industry data use a different methodology from official authorisation and listing statistics, but illustrate the importance of the post-authorisation phase.

International pathways can shorten the distance

Between 2021 and 2025, Swissmedic used at least one facilitated review pathway for 68 per cent of applications. These routes include accelerated or temporary authorisation, reliance under Article 13 of the Therapeutic Products Act, the Access Consortium and Project Orbis.

Orbis enables selected oncology dossiers to be reviewed in parallel with international partner authorities. The Access Consortium divides parts of an assessment among several medium-sized regulators. A Swissmedic explanation of the submission gap indicates that Access can materially reduce filing delays and that oncology dossiers in Orbis have also been submitted much earlier. Switzerland still makes its own decision and retains a national benefit-risk assessment.

What pharmaceutical companies should change strategically

1. Put Switzerland into the global sequence early

A Swiss dossier should not start only after the major markets. Early regulatory advice, localised documentation, resource planning and a robust business case belong before the first international filing.

2. Assess Access, Orbis and reliance systematically

The pathway should be chosen according to indication, evidence, dossier status and available reference decisions. A late review of suitable cooperation or reliance routes wastes time that is difficult to recover later.

3. Prepare authorisation and reimbursement in parallel

Regulatory Affairs, Market Access, Medical, Pricing and Supply Chain need one shared critical path. Evidence requirements, comparator choices, pricing logic and the dossier for the List of Pharmaceutical Specialities should not begin only after the Swissmedic decision.

4. Secure launch and supply readiness early

A positive decision alone does not supply a pharmacy or a patient. Master data, packaging, forecasting, initial stock, wholesaler listing, GDP-compliant distribution and information for healthcare professionals must all be ready for the intended access date.

What authorities and policymakers can accelerate

The strongest public levers are transparent requirements, digital applications, clear timelines, international cooperation and better alignment between authorisation and reimbursement. The Federal Office of Public Health describes ongoing work to modernise and accelerate listing and pricing procedures. Speed must not replace scientific scrutiny or the long-term affordability of the healthcare system.

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