Swissmedic, EMA and FDA Compared
Short answer
Swissmedic is a national authority outside the EU system: no automatic recognition, but a duty to take foreign assessment results into account under Art. 13 TPA. Dossier format and scientific requirements match the international standard, while the procedure itself is smaller, more direct and quicker to engage with.
How do the three systems actually differ?
The dossier format is the CTD everywhere, and the scientific guidelines follow ICH. The differences lie in the procedure: committee structure, duration, fee levels, data exclusivity, and how far an authority draws on other authorities' assessments.
| Feature | Swissmedic | EMA | FDA |
|---|---|---|---|
| Scope | Switzerland and Liechtenstein | EU and EEA | United States |
| Legal basis | TPA, TPO, MPLO | Regulation (EC) 726/2004, Directive 2001/83/EC | FD&C Act, 21 CFR |
| Decision | Swissmedic decision | Commission decision following a CHMP opinion | Approval letter from the Center |
| Standard regulatory time | around 330 days | 210 days of assessment time plus clock stops | 10 months standard, 6 months priority |
| Dossier | CTD, Module 1 Switzerland-specific | CTD, Module 1 EU | eCTD, Module 1 US |
| Consideration of foreign assessments | enshrined in law (Art. 13 TPA) | no | no |
| Data exclusivity, new active substance | 10 years | 8 years plus 2 years market exclusivity | 5 years NCE |
| Fee, new active substance | mid five-figure CHF range | high six-figure EUR range | several million USD |
| Language of the information | German, French, Italian | all official languages of the states concerned | English |
What does this mean for the order of submissions?
Filing first in the EU or the US lets you save time and fees in Switzerland through Art. 13 TPA and make use of the assessment report. Choosing Switzerland first gains earlier market access in a country with a high price level, but forgoes the efficiency gain from the foreign report.
- EU first, Switzerland later: shortest Swiss regulatory time, lowest fee, strong basis for argumentation.
- Switzerland in parallel: makes use of the Access Consortium and coordinated timetables, though internal effort increases.
- Switzerland first: sensible for small indications, orphan drugs, or where Switzerland is a reference market for prices.
- Regardless of the order: plan the Swiss Module 1 and the trilingual medicinal product information early.
Where do the substantive requirements diverge?
The scientific substance is largely the same. Differences arise in the medicinal product information, which follows the Swissmedic template, in the dispensing category, which is set independently, and in comparators, where what matters is what is authorised and reimbursed in Switzerland.
Frequently asked questions
Does an EU authorisation apply in Switzerland?
No. Placing a product on the market in Switzerland requires a Swissmedic authorisation. However, the EU authorisation can substantially shorten the procedure under Art. 13 TPA.
Is Swissmedic stricter than the EMA?
Neither stricter nor more lenient, but independent. Differences usually appear in indication wording, warnings and the dispensing category, not in the underlying benefit-risk assessment.
Are GMP certificates from the EU recognised?
Yes. Thanks to the Mutual Recognition Agreement on conformity assessment, GMP inspection results from the EEA are recognised, which avoids duplicate inspections.
What role does Liechtenstein play?
Under its customs treaty with Switzerland, Liechtenstein adopts Swiss therapeutic products law. A Swissmedic authorisation therefore also has effect for Liechtenstein.
What is the Access Consortium compared with the EU procedure?
A voluntary work-sharing arrangement between five authorities, each still taking its own national decision. Unlike the centralised EU procedure, it does not produce a single authorisation, only a coordinated timetable.
Sources
- Fedlex SR 812.21 TPA
- Swissmedic: About Us and International Cooperation
- EMA: Authorisation of medicines
Last updated: