Accelerated Authorisation Procedure under Art. 7 TPO
Short answer
The accelerated authorisation procedure shortens the regulatory time to around 140 days. Swissmedic admits it where there is a serious, disabling or life-threatening disease, no equivalent therapy is authorised, and a high therapeutic benefit is expected. Admission to the procedure must be requested separately.
What criteria does Swissmedic assess?
Swissmedic assesses three cumulative criteria: the disease must be serious, disabling or life-threatening, there must be no authorised equivalent medicinal product, and the available data must demonstrate a high therapeutic benefit. All three must be substantiated in the application, not merely asserted.
- Severity of the disease: mortality, morbidity, rate of progression, population affected.
- Therapy gap: a list of alternatives authorised in Switzerland and reasoning why they are not equivalent.
- Expected benefit: quantified efficacy versus the standard of care, clinically relevant endpoints.
How do I apply for admission to the procedure?
Before submitting the marketing authorisation application, you file a separate request for admission to the accelerated procedure. It sets out reasoning on the three criteria, the state of the dossier, and the planned submission date. Swissmedic decides within a few weeks and communicates the timeline.
- Submit the request for admission to the accelerated procedure with reasoning on the three criteria.
- Wait for Swissmedic's decision; if refused, the standard procedure or pre-notification remains available.
- Submit the marketing authorisation application with a complete dossier on the agreed date.
- Go through the shortened assessment, generally with one round of questions and short response periods.
- Receive the preliminary decision and final decision, often with conditions on follow-up monitoring.
How does this compare with the EMA and FDA?
Switzerland has no equivalent to the FDA Breakthrough Therapy Designation and no PRIME status with early scientific support over several years. The accelerated procedure only takes effect at the marketing authorisation application stage. For early advice, Swissmedic offers scientific advice meetings, which are fee-based.
| Authority | Instrument | Effect |
|---|---|---|
| Swissmedic | Accelerated procedure (Art. 7 TPO) | Regulatory time around 140 days |
| Swissmedic | Temporary authorisation (Art. 9a TPA) | Authorisation with incomplete data, subject to conditions |
| EMA | Accelerated Assessment | Assessment in 150 instead of 210 days |
| EMA | PRIME | Early and ongoing scientific support |
| FDA | Priority Review | Decision in 6 instead of 10 months |
| FDA | Accelerated Approval | Approval on a surrogate endpoint, with a confirmatory study |
Can the procedure be combined with other instruments?
The accelerated procedure can be combined with a temporary authorisation under Art. 9a TPA where the data is incomplete. It cannot be combined with the procedure with pre-notification. Orphan drug status under Art. 4 of the Ordinance on the Simplified Authorisation of Medicinal Products (VAZV) is independent of it and brings fee relief.
Frequently asked questions
How long does the decision on admission to the procedure take?
A few weeks in practice. Plan for the decision so that, if refused, you can proceed under the standard procedure or with pre-notification without losing time.
Does orphan drug status automatically bring the accelerated procedure?
No. Orphan drug status under Art. 4 VAZV concerns the simplified authorisation and fee relief. Admission to the accelerated procedure is decided separately, against the criteria in Art. 7 TPO.
Are the fees higher?
The fee for the underlying authorisation procedure continues to apply; an additional fee is charged for prioritisation. The current Fee Ordinance is authoritative.
What counts as an equivalent therapeutic alternative?
A medicinal product authorised in Switzerland with comparable benefit in the same indication and population. Off-label use or an individual import does not count as an authorised alternative.
Sources
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