24.07.2024
International comparison of Swiss authorisation times
12.07.2024
Swissmedic launches the public consultation on 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” of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), with a deadline of 30 August 2024 for comments
11.07.2024
Pyrogen tests without rabbits: the European Pharmacopoeia is dispensing with animal testing
05.07.2024
COVID-19 vaccinovigilance reports up to the end of June 2024
02.07.2024
Swissmedic is issuing an urgent warning regarding slimming products and other supposedly natural products
02.07.2024
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
01.07.2024
Update of the TPLRO and TPLO annexes
01.07.2024
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
01.07.2024
The new practice and the revised Guidance document SwissPAR come into effect on 1 July 2024
01.07.2024
Swissmedic is reducing the fees for processing applications to non-commercially funded clinical trials by 80% effective 1 July 2024.
26.06.2024
A call for vendor participation has now been published on the official ICH website
19.06.2024
Continued advancement of ICH’s global harmonisation efforts in Fukuoka, Japan
17.06.2024
Changes to the declaration of medicinal products and narcotics
15.06.2024
Swissmedic has simplified the requirements for renewed authorisation of medicinal products
10.06.2024
Federal Council decides on measures to improve healthcare for women
07.06.2024
In 1964, Switzerland was one of the first eight signatories of the Convention on the Elaboration of a European Pharmacopoeia
07.06.2024
The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024.
07.06.2024
On 7 June 2024 the Federal Council ratified Swissmedic’s 2023 reporting and approved the Annual Report.
01.06.2024
Simplification of rules on issuing new packaging codes and elimination of subsumption of fees for multiple applications
01.06.2024
Preliminary Decision Clarification Meeting introduced as a pilot
01.06.2024
The revised Guidance document Time limits for authorisation applications is valid with effect from 1 June 2024.
29.05.2024
Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs
17.05.2024
Scientific article on the development and application of the "Carcinogenic Potency Categorisation Approach" (CPCA) published
24.04.2024
Swiss Agency for Therapeutic Products supports creation of optimum framework conditions for Swiss biotech industry
18.04.2024
Grant agreement signed to continue supporting regulatory authorities in low and middle-income countries for a further three years
26.03.2024
"Lemon Bottle" lipolysis solution is not approved for distribution in Switzerland and must not be sold or used
06.03.2024
Swissmedic’s preliminary recommendation
04.03.2024
Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
12.02.2024
41 human medicinal products with new active substances authorised
08.02.2024
Number of illegally imported medicinal products remains at the same level
