Highlighted

History 1900–2022 From the establishment of the IOCM to the Swissmedic of today

1900

The Intercantonal Office for the Control of Medicines (IOCM) is established.

13.09.1991

Switzerland becomes the 33rd member of the WHO International Drug Monitoring Programme in Uppsala, Sweden.

Register of Cures 16001–18000

01.03.1999

The Federal Council signs off the draft legislation for the new Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act) and its dispatch for debate by parliament. This is the first time that the control of therapeutic products has been regulated comprehensively by the federal government. It also creates the basis for establishing a national agency for therapeutic products.

28.09.2001

The Federal Council decides to implement the Therapeutic Products Act and the associated ordinances with effect from 1 January 2002.

01.01.2002

The IOCM merges with the Therapeutic Products Section of the Federal Office of Public Health to form Swissmedic, Swiss Agency for Therapeutic Products. The Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA) and the associated ordinances enter into force.

2002

The Agency Council approves the purchase of the printing plant owned by Stämpfli AG at Hallerstrasse 7 in Bern.

Printing office Stämpfli

2003

The Pharmacopoeia Helvetica is published for the first time by Swissmedic (this is the 9th edition overall).

Pharmacopoea Wirtenbergica
Pharmacopoea Helvetica

August 2004

The Control Committee of the Council of States (CC-S) publishes a report on the difficulties of creating and starting business operations at Swissmedic.

Potassium iodide tablets

2004

  • Potassium iodide tablets are distributed to more than a million people living in the vicinity of nuclear power plants in a project managed by Swissmedic. These tablets are intended to protect the thyroid gland in the event of a serious incident at a nuclear power plant involving leakage of radioactivity. So far, it is the biggest undertaking of its kind worldwide to protect the health of the population.
  • A Memorandum of Understanding between the American regulatory authority FDA and Swissmedic is signed.
  • The new Veterinary Medicinal Products Ordinance enters into force in September.
  • Swissmedic publishes the Guideline on Medicines and the Internet developed in conjunction with the Council of Europe. The central message is a warning about obtaining medicines online.
Office spaces of Swissmedic

2005

  • Swissmedic moves into its new offices at Hallerstrasse 7 in Bern in the first calendar quarter.
  • In November the Control Committee of the Council of States (CC-S) certifies that Swissmedic has worked well in developing the organisation. This assessment encourages Swissmedic to maintain its approach.

2006

  • May – June – The Agency Council launches a project to analyse processes and organisation with the aim of establishing a clear basis for reorganising Swissmedic. The Management Board is restructured as part of this reorganisation. Five of the eight Management Board members leave Swissmedic.
  • A number of agreements are signed with international partner authorities.
    – The GMP/GLP arrangement with Japan is finalised.
    – A Memorandum of Understanding with Australia is signed.
    – A Memorandum of Understanding with Canada is signed.
    These formal agreements enable information to be exchanged about individual preparations and products.
    Swissmedic and the European authority EMEA (now EMA) work towards further collaboration. Swissmedic is invited to sit on a number of technical committees as an observer.
  • The ordinances on complementary and herbal medicinal products, hospital products and medicinal products to treat rare or life-threatening diseases are adopted.
  • The Federal Council transfers oversight of Swissmedic from the Federal Office of Public Health (FOPH) to the General Secretariat of the Federal Department of Home Affairs (FDHA).

2007

  • 1 July – The Transplantation Act and the associated ordinances enter into force.
  • The Access Consortium, consisting of the regulatory authorities in Australia, Canada, Singapore and Switzerland, is established.
  • The Veterinary Medicinal Products Ordinance (VMPO) implementation project is concluded. The ordinance ensures the correct use of veterinary medicinal products to protect food of animal origin against unwanted medicinal product residues.
  • From July, Swissmedic works in the new process-oriented organisational structure.

2008

  • March – An agreement to exchange information on therapeutic products is signed with the Health Sciences Authority, the regulatory authority in Singapore.
  • Swissmedic organises the 13th International Conference of Drug Regulatory Authorities (ICDRA) in Bern from 16 to 19 September in conjunction with the WHO. It is attended by over 300 delegates representing regulatory authorities in around 100 countries.
Logo ICDRA

2009

  • The year is overshadowed by the influenza A (H1N1) virus pandemic, also known as swine flu. Swissmedic authorises two vaccines: Pandemrix and Celtura.
  • June – Swissmedic organises the international conference of the Permanent Forum on International Pharmaceutical Crime (PFIPC) and the International Laboratory Forum on Counterfeit Medicines (ILFCM) in Bern.
  • 1 October – The online tool Paniflow is implemented to monitor the safety of pandemic medicines.

2010

Swissmedic accepts authorisation applications in eCTD format, i.e. electronically, without hard copies.

Office spaces of Swissmedi

2011

Switzerland signs the European Council’s Medicrime Convention to combat the counterfeiting of therapeutic products.

2012

  • Swissmedic turns 10 and organises an International Regulatory Symposium on 21 and 22 September to mark the anniversary. It is attended by more than 300 interested parties from Switzerland and abroad.
  • Swissmedic organises the first Meeting on Quality Defects with participants from a large number of EU partner authorities and the EMA. This lays the foundation for an international exchange on quality problems that still exists today.
Laboranten von Swissmedi

2013

  • The Federal Council adds development cooperation to Swissmedic’s service mandate.
  • 1 January – The AIPS medicinal product information publication platform is launched, providing access to information for patients and healthcare professionals for all human medicinal products free of charge.
  • April – The new Swissmedic building in Freiburgstrasse is officially opened – this is where all the Agency’s laboratories are located.
  • October – ElVis (Electronic Vigilance System) is launched. It is an online system for reporting suspected adverse reactions to medicinal products.

2014

  • 50 years of the European Pharmacopoeia. Switzerland is one of the eight founding members of this publication containing quality specifications that are harmonised throughout Europe.
  • A Memorandum of Understanding between the Bill & Melinda Gates Foundation, the Federal Department of Home Affairs (FDHA) and the Federal Department of Foreign Affairs (FDFA) to promote development cooperation is signed.
  • May – Swissmedic organises the international meeting of the Competent Authorities for Medical Devices (CAMD). The European partner authorities discuss the future development of market surveillance and elect a new Executive Group.
  • June – Swissmedic becomes a member of the ICH and is henceforth represented in the Assembly and the Management Committee.

2015

Swissmedic organises a conference to mark the 150th anniversary of the Swiss Pharmacopoeia (Ph. Helv.).

2016

  • Tobias Gosdschan, Head of the Pharmacopoeia Division at Swissmedic, becomes the first Swiss Chair of the European Pharmacopoeia Commission in the more than 50-year history of the European Pharmacopoeia.
  • 11 to 13 October – Swissmedic hosts the Summit of Heads of Medicines Regulatory Agencies symposium in Interlaken. Around 75 delegates from 23 countries attend this international meeting of regulatory agency heads.
Tobias Godschan
Logo Summit Head of Medicines Regulatory Agencies

2017

Work starts on revising the legislation governing medical devices. The In Vitro Diagnostic Medical Devices Ordinance (IvDO) is scheduled to come into effect in May 2022.

Laboratory work at Swissmedic

2018

  • Temporary authorisations are introduced to facilitate rapid access to medicines to treat life-threatening or disabling diseases.
  • The OMCL network develops a new method to identify carcinogenic substances in medicinal products.
  • 25 October – Medicrime Convention: Switzerland signs the Convention in 2011; it is ratified on 25 October 2018. It constitutes another instrument to intensify national and international efforts to combat counterfeit medical products.

2019

  • The first revision of the Therapeutic Products Act (TPA) enters into force (HMG 2 including the implementing ordinance HMV 4).
  • Swissmedic organises the Meeting on Quality Defects for the third time at the request of the EMA. A large number of delegates from the EU are joined by experts from Canada, Singapore and Argentina.

2020

  • 2 July – Swissmedic tweets for the first time.
  • June – The first edition of Swissmedic’s "Visible" magazine is published.
  • 19 December – The first COVID vaccine Comirnaty® is authorised – Swissmedic is the first authority worldwide to grant approval in an ordinary authorisation procedure.
  • The UK Medicines and Healthcare products Regulatory Authority becomes a new member of the Access Consortium.

2021

  • 12 January – The second COVID vaccine Spikevax® is authorised.
  • 26 May – The new regulations governing medical devices, the revised Therapeutic Products Act and Human Research Act, the new MedDO and the new ordinance specifically regulating clinical trials with medical devices enter into force.