Context sidebar

Information

05.11.2025

Use of titanium dioxide in medicinal products

Titanium dioxide continues to be permitted as an excipient in medicinal products in Switzerland

01.11.2025

Modification of the information sheet Drug Safety Reporting Duties in Switzerland

Update of contact details and document links

01.10.2025

Changes to the Guidance document Meetings for applicants for authorisation procedures

Preliminary Decision Clarification Meeting for human medicinal products to be introduced

01.09.2025

Disposal information to be added to Patient information

Change to the Guidance document Product information for human medicinal products

01.09.2025

Revision of the guidance document Formal requirements

Swissmedic has revised the guidance document Formal requirements accordingly, and this will enter into force on 1 September 2025

01.09.2025

Changes to the guidance document Time limits for authorisation applications

Shortening of time limits for applications for new authorisation of medicinal products with known active substances without innovation under Art. 13 TPA

01.09.2025

Duration of contraception following the end of treatment with medicinal products with genotoxic potential

Swissmedic requests marketing authorisation holders to review their medicinal products with genotoxic potential

01.09.2025

Revision of the guidance document "Renewal and discontinuation of authorisation or change of status (main authorisation / export licence)"

Swissmedic clarifies the requirements for the renewal and change of status of medicinal product authorisations

18.08.2025

Benchmarking study 2024

International comparison of Swiss authorisation times

01.07.2025

Adaptation of guidance document "DHPC HMP"

New identification of DHPCs with the "Red safety information" symbol

18.06.2025

Risk assessment relating to nitrosamines in active substances and/or finished medicinal products

Swissmedic establishes the requirement to submit risk assessments relating to nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents

01.06.2025

Swissmedic position on conjugated pneumococcal vaccines

Swissmedic updates requirements for authorisation applications for conjugated pneumococcal vaccines

01.06.2025

Changes to the guidance document Time limits for authorisation applications

Time limits shortened for additional indications for Orbis type A and fast-track Orbis type B

01.05.2025

Parallel imports: Changes to the guidance document and to the form

Clarifications and changes

01.04.2025

Expansion of the Swissmedic position paper on real world evidence

Swissmedic is expanding its position paper on real world evidence (RWE) with an overview of relevant international guidelines and publications

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Regulatory Assessment (XLSX, 268 kB, 12.11.2025)

Allocation of ATC code and IT groups KPA (XLSX, 255 kB, 01.05.2025)

Top of page