General communications


Public consultation for ICH Guideline M14 “Bioequivalence for Immediate-Release Solid Oral Dosage Forms General principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines” launched in Switzerland

Swissmedic launches the public consultation on Guideline M14 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines), with a deadline of 30 August 2024 for comments


The European Pharmacopoeia is abolishing testing on rabbits

Pyrogen tests without rabbits: the European Pharmacopoeia is dispensing with animal testing


Reports of suspected adverse reactions to the COVID-19 vaccines in Switzerland

COVID-19 vaccinovigilance reports up to the end of June 2024


Update – Warning about supposedly herbal products

Swissmedic is issuing an urgent warning regarding slimming products and other supposedly natural products


Update to the forms New authorisation of human medicinal products and Variations and authorisation extensions HAM

Swissmedic clarifies in the authorisation forms how to describe the indication of the medicinal product and simplifies the standardised consents for sharing information with partner authorities


TPLRO, TPLO: Update of annexes

Update of the TPLRO and TPLO annexes


Ordinance 3 on Measures to Combat the Coronavirus (COVID-19) ceases to apply as of 30 June 2024

As there will no longer be any legal basis for doing so, Swissmedic will cease granting exceptions with regard to the authorisation and importing of medicinal products for the treatment or prevention of COVID-19


Standardisation of practice on publication of indications in Swiss Public Assessment Report

The new practice and the revised Guidance document SwissPAR come into effect on 1 July 2024


Fee reduction for non-commercially funded clinical trials

Swissmedic is reducing the fees for processing applications to non-commercially funded clinical trials by 80% effective 1 July 2024.


ICH call for vendor participation now open

A call for vendor participation has now been published on the official ICH website


Meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Continued advancement of ICH’s global harmonisation efforts in Fukuoka, Japan


Simplification of requirements for renewed authorisation of medicinal products

Swissmedic has simplified the requirements for renewed authorisation of medicinal products


Better representation of women in medical research

Federal Council decides on measures to improve healthcare for women


60th anniversary: European Directorate for the Quality of Medicines & HealthCare and European Pharmacopoeia

In 1964, Switzerland was one of the first eight signatories of the Convention on the Elaboration of a European Pharmacopoeia


New implementing regulations apply as of 1 November 2024

The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024.


Swissmedic publishes its Annual Report for 2023

On 7 June 2024 the Federal Council ratified Swissmedic’s 2023 reporting and approved the Annual Report.


Changes to the Guidance document Variations and extensions HAM

Simplification of rules on issuing new packaging codes and elimination of subsumption of fees for multiple applications


Changes to the Guidance document Meetings for applicants for authorisation procedures

Preliminary Decision Clarification Meeting introduced as a pilot


Changes to the Guidance document Time limits for authorisation applications

The revised Guidance document Time limits for authorisation applications is valid with effect from 1 June 2024.


Project Orbis: quicker access to promising cancer treatments

Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs


Publication with Swissmedic involvement on the risk assessment of nitrosamine impurities

Scientific article on the development and application of the "Carcinogenic Potency Categorisation Approach" (CPCA) published


Swissmedic participation at Swiss Biotech Day in Basel

Swiss Agency for Therapeutic Products supports creation of optimum framework conditions for Swiss biotech industry


Swissmedic receives grant from the Bill & Melinda Gates Foundation

Grant agreement signed to continue supporting regulatory authorities in low and middle-income countries for a further three years


Swissmedic issues warning about the illegal medicinal product "Lemon Bottle" lipolysis solution

"Lemon Bottle" lipolysis solution is not approved for distribution in Switzerland and must not be sold or used


Fennel tea for pregnant women, infants and children under 4 years

Swissmedic’s preliminary recommendation


Public consultation on ICH Guideline E2D(R1) launched in Switzerland

Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports


Authorisations of human medicinal products with a new active substance and additional indications 2023

41 human medicinal products with new active substances authorised


Illegal imports of medicinal products: Erectile stimulants account for more than two-thirds

Number of illegally imported medicinal products remains at the same level


Voluntary prior notification of new applications with new active substance for human medicinal products

Prior notification of a new application with a new active substance enables Swissmedic to plan resources early on and supports efficient processing of applications

Last modification 22.11.2022

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