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Information

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

01.04.2025

Changes to the Guidance document Meetings for applicants for authorisation procedures

Optimisation of meetings for applicants for authorisation procedures

01.04.2025

Changes to the Guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products

Clarification of the submission date for an authorisation application for a fast-track authorisation procedure (FTP) or the implementation of temporary authorisation (temp.auth./temp.AI)

17.03.2025

Newly appointed Swissmedic Expert Committees start work

The Swissmedic Medicines Expert Committees (SMEC) have begun the 2025–2028 period of office with a new line-up

07.03.2025

Overview of international authorisation procedures

International collaboration in authorisation procedures

01.03.2025

Changes to the Guidance document “Information on PSUR PBRER submission HMP”

Editorial revision

28.02.2025

Authorisations of human medicinal products with a new active substance and additional indications 2024

46 human medicinal products with new active substances authorised

01.01.2025

Optimisation of labelling phase for human medicinal products

Swissmedic is optimising the labelling phase: text review letters should be avoided where possible and the Swissmedic time limits are being shortened

01.01.2025

Changes to the form Information for application Art. 13 TPA

The previous form Information for application Art. 13 TPA has been divided into two forms: one specifically for veterinary medicinal products and the other for human medicinal products

01.01.2025

Election of the members of the Swissmedic Medicines Expert Committees

Election and re-election of our external experts for the new period of office 2025–2028

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Regulatory Assessment (XLSX, 266 kB, 23.07.2025)

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

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