Swissmedic (the Swiss Agency for Therapeutic Products)
Who regulates medicines in Switzerland?
In one sentence
Swissmedic is Switzerland's regulator of medicines and medical devices: a public institution that licenses products and watches their safety.
It is affiliated to the Federal Department of Home Affairs but keeps its own books and lives mostly on fees. Switzerland is not in the European Union (EU), so a Swiss adverse reaction report goes to Swissmedic in Bern, not to EudraVigilance.
Where it sits
- GovernmentThe Federal Council, which appoints the Agency Council
- DepartmentFederal Department of Home Affairs (FDHA)
- Public institutionSwissmedic, its own legal personality and accounts
- Regional centresBasel, Geneva, Lausanne, Zurich and LuganoProfessionals’ reports are assessed here
Think of it like this
Think of a toll bridge the state built and then told to pay its own way: public property, its own board, paid by those who cross.
Key insights
The Act lets Swissmedic use its funding as it sees fit and keep its own accounts. Of 115 million francs of net income in 2024, the federal contribution was under 20 million. With 520 planned posts it calls itself the smallest of the leading agencies.
Swissmedic opened on 1 January 2002, the day the Therapeutic Products Act came into force, out of the cantons’ joint control office and a unit of the Federal Office of Public Health. Three seats on its council may still be proposed by the cantons. Chapter 1 tells the story.
A Swiss report never travels to EudraVigilance. Companies send it to Swissmedic electronically, through a gateway or the ElViS portal, within 15 or 60 days; doctors and pharmacists report straight to Swissmedic, and five regional centres help assess. Chapter 2 sets the clocks.
On 30 October 2023 the World Health Organization (WHO) listed Swissmedic among its first WHO Listed Authorities, in all regulatory functions. It is a founding member of the Access Consortium with Australia, Canada and Singapore and a standing regulatory member of the International Council for Harmonisation (ICH).
Jump to: 1 Three moments 2 Your report, their clock 3 Side by side with the EU 4 Test yourself
Chapter 1
Which three moments made Swissmedic what it is?
Pick a year. Each set a piece of the Swiss way, from the cantons to the World Health Organization (WHO).
One institute replaces the cantons’ office
Until 2001 the cantons controlled medicines through a joint office, with a federal unit beside it. The Therapeutic Products Act of 15 December 2000 merged the two; Swissmedic opened on 1 January 2002, the day the Act came into force.
The Act gave it an unusual shape: an institution under public law with its own legal personality, run by the Confederation “with the cooperation of the cantons”. Its Agency Council has at most seven members, appointed by the Federal Council; three may be proposed by the cantons.
What it left behind: a federal regulator with cantonal seats on its board, paid by the companies it checks.
The revised Act writes the clocks
On 1 January 2019 the revised Act and a package of eight ordinances came into force, five of them enacted by the Agency Council itself. The Medicinal Products Ordinance of 21 September 2018 is where the reporting rules now live, with the deadlines you meet in chapter 2.
It also made two things explicit. A company’s reporting duty runs from the day it files its application until the last batch it shipped expires, and every company must name a qualified person responsible for meeting it. Two years later, from 1 July 2021, Swissmedic stopped accepting anything but electronic reports.
What it left behind: a 15, 60 and 5 day rulebook, and a fully electronic inbox.
On the WHO’s first list
On 30 October 2023 the World Health Organization published its first list of WHO Listed Authorities, regulators assessed with its Global Benchmarking Tool and found to meet international standards. Swissmedic was on it, recognised in all regulatory functions.
The year after, it ran on its own cloud for the first time, opened a new portal and put a rebuilt adverse reaction database into service. In 2024 it took in 13,461 reports including follow-ups, closed 441 signal procedures and ordered risk-minimising changes to the product information of 503 medicines.
What it left behind: a small agency other regulators are allowed to rely on.
Chapter 2
Your report, their clock
A case detected in Switzerland has reached your company. The Medicinal Products Ordinance sets the deadline with two questions: is it serious, and is it already known? Pick a cell.
Or it is not a single case: or
A serious suspected reaction detected in Switzerland goes to Swissmedic within 15 days of the day you learned of it, by gateway or ElViS. Cases from abroad arrive as signals, not one by one. Arzneimittelverordnung, Artikel 61 and 62
A non-serious reaction that is not yet known has 60 days. Arzneimittelverordnung, Artikel 62, Absatz 1
A non-serious reaction already in the product information is not reported as a single case. If such reactions start to cluster, the cluster itself is a report, due within 15 days. Arzneimittelverordnung, Artikel 61 and 62
The Act makes it a duty, not an invitation: a professional who dispenses or administers medicines must notify serious or previously unknown effects, serious ones within 15 days, through ElViS. A regional centre may help assess the case. Heilmittelgesetz, Artikel 59, Absatz 3; Arzneimittelverordnung, Artikel 63
A signal that calls for quick measures is reported at once and within five days at the latest, as a report with the measures you propose. Other signals with serious potential have 15 days. Arzneimittelverordnung, Artikel 61, Absatz 5, and 62, Absatz 2
Schwerwiegende unerwünschte Arzneimittelwirkungen oder Beobachtungen schwerwiegender Tatsachen müssen innerhalb von 15 Tagen gemeldet werden.
Arzneimittelverordnung, Artikel 63: a professional’s serious case, within 15 days
Companies file electronically only, by gateway or ElViS. Doctors and pharmacists have reported straight to Swissmedic since 2021, assessed with the five regional centres; everything then goes on to the WHO programme in Uppsala.
Chapter 3
Side by side with the EU
Switzerland runs its own rulebook. Five places where it differs from the EU.
| The EU rule | The Swiss rule | |
|---|---|---|
| Who decides | The European Commission, on the opinion of the European Medicines Agency (EMA), for centralised medicines | Swissmedic alone; the Federal Council appoints its council, not its decisions |
| Where a serious case goes | EudraVigilance within 15 days, wherever it happened | Swissmedic, within 15 days, only for cases detected in Switzerland; foreign cases arrive as signals |
| A non-serious case | 90 days if it happened in the Union | 60 days if not yet known; otherwise no single-case report unless cases cluster |
| A doctor’s serious case | Reporting is encouraged | A legal duty under the Act, within 15 days |
| Signals | Assessed at the EMA’s safety committee | The company reports a signal with proposed measures: five days if urgent, 15 if its potential is serious |
Show the legal references
- Who decides: Regulation (EC) No 726/2004, Article 10(1); Heilmittelgesetz, Artikel 68; the Swissmedic page on the Agency Council.
- Serious cases: Directive 2001/83/EC, Article 107(3); Arzneimittelverordnung, Artikel 61, Absatz 1 and 4, and 62, Absatz 1.
- Non-serious cases: Directive 2001/83/EC, Article 107(3); Arzneimittelverordnung, Artikel 62, Absatz 1.
- Professionals: Directive 2001/83/EC, Article 102(a); Heilmittelgesetz, Artikel 59, Absatz 3; Arzneimittelverordnung, Artikel 63.
- Signals: Arzneimittelverordnung, Artikel 61, Absatz 5, and 62, Absatz 2.
Same two questions as Brussels, a different address: the clock runs to Bern, and only for what happened in Switzerland.
The facts, in one place
| What it is | An institution under public law with its own legal personality, affiliated to the Federal Department of Home Affairs (Therapeutic Products Act, article 68). |
|---|---|
| Since | 1 January 2002, under the Act of 15 December 2000; the revised Act and ordinances since 1 January 2019. |
| Who decides | The Agency Council (up to seven members, appointed by the Federal Council for four years, three on the cantons’ proposal) supervises; a management board runs the agency of 597 staff. |
| Seat | Bern, Hallerstrasse 7. |
| Money | Net income of 115.2 million francs in 2024, mostly fees and levies; federal contribution 19.7 million; a deficit of 23.4 million covered by reserves. |
| 2024 in numbers | 13,461 adverse reaction reports including follow-ups; 441 signal procedures closed; 630 risk management plans and periodic safety reports assessed; 46 new active substances authorised. |
| Member of | The International Coalition of Medicines Regulatory Authorities (ICMRA); the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since 1971; the International Council for Harmonisation (ICH), a standing regulatory member; the Access Consortium; the WHO drug monitoring programme; a WHO Listed Authority since 30 October 2023. |
Don’t confuse it with: the Federal Office of Public Health
Swissmedic
The regulator
- Decides: whether a medicine may be sold and what its product information says
- Is: a public institution with its own council and accounts
- Example: acts on a canton’s finding about a product
Federal Office of Public Health (FOPH)
The ministry’s office
- Prepares: health policy and the law; Swissmedic may be asked to help draft it
- Is: a federal office in the same department; its therapeutic products unit went into Swissmedic in 2002
- Example: receives the cantons’ findings in its own field
Chapter 4
Test yourself
Myth or Truth? Pick an answer to see the explanation.
“A Swiss marketing authorisation holder sends its serious cases to EudraVigilance.”
Switzerland is not in the EU. Serious cases detected in Switzerland go to Swissmedic within 15 days, electronically through the gateway or ElViS, under articles 61 and 62 of the Medicinal Products Ordinance.
“Swissmedic is financed mainly by fees, not by the federal budget.”
The Act lets it use its funding as it sees fit and keep its own accounts. Of a net income of 115 million francs in 2024, the federal contribution was 19.7 million; the rest came from fees, levies and services.
Sources (17)
- Swissmedic: Organisation
- Swissmedic: Agency Council
- Swissmedic: Pharmacovigilance
- Swissmedic: Reporting adverse drug reactions for healthcare professionals
- Swissmedic, 13 April 2021: electronic pharmacovigilance reporting for companies
- Swissmedic, 1 November 2023: Swissmedic confirmed as WHO Listed Authority
- Swissmedic, 6 June 2025: Annual Report and financial statements for 2024
- Swissmedic: Geschäftsbericht 2024 (PDF, German)
- Therapeutic Products Act (TPA), SR 812.21 (Fedlex)
- Arzneimittelverordnung (VAM), SR 812.212.21 (Fedlex)
- Swissmedic: Legal basis for the Ordinary Revision of the TPA
- Swissmedic, 14 October 2020: the Australia-Canada-Singapore-Switzerland (ACSS) Consortium welcomes the U.K.
- ICMRA: Membership
- PIC/S: Participating Authorities
- Food and Drug Administration (FDA): ICH overview (PDF)
- Directive 2001/83/EC, consolidated text (EUR-Lex)
- Regulation (EC) No 726/2004, consolidated text (EUR-Lex)
Last reviewed against these 17 sources. Every page is reviewed at least every six months.
