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General communications

06.07.2026

CIRS study on authorisation times for human medicinal products with new active substances confirms Swissmedic’s competitiveness internationally

International authorisation times for human medicinal products with new active substances during the period 2016–2025

01.07.2026

TPLRO, TPLO: Update of annexes

Update of the TPLRO and TPLO annexes

01.07.2026

swissdamed: As of 1 July 2026, mandatory registration applies to medical devices and in vitro diagnostic medical devices

New requirements for manufacturers and authorised representatives

01.07.2026

Patient information and Information for healthcare professionals for human medicinal products: Change to the templates

Change to the Patient information and Information for healthcare professionals templates

30.06.2026

Cross-agency targeted campaign "Peptides 2026"

Swissmedic and SSI warn of the health risks associated with illegally imported peptides and conduct a joint campaign with FOCBS

22.06.2026

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

The Assembly of the ICH met in person on 2–3 June 2026 in Rio de Janeiro, Brazil, for its biannual meeting

19.06.2026

Revision of the Swissmedic Fees Ordinance on 1 July 2026

New fee schedule for charging by time

18.06.2026

Revised annex 3a TPLRO

Polysorbates as excipients of particular interest

15.06.2026

SEND datasets for new authorisation applications for human medicinal products with new active substances

Submission will be mandatory from 15 June 2026

12.06.2026

Swissmedic publishes its Annual Report and financial statements for 2025

Federal Council approves Swissmedic’s Annual Report and financial statements

08.06.2026

Studies by Swissmedic, University Hospital Zurich and the University of Zurich have analysed the assessment of cancer drugs

Successful collaboration in the analysis of authorisation data for oncology drugs over the last 20 years in Switzerland

01.06.2026

Updated guidelines for quality assurance in transfusion practice

The second version of the guidelines has been updated and expanded

01.06.2026

swissdamed Webinar: How to register and manage medical device data in swissdamed

Presentation and recording now available

01.06.2026

Changes to the Project Orbis guidance document

Project Orbis guidance document updated

28.05.2026

Federal contribution to the Swiss Agency for Therapeutic Products Swissmedic to be increased

Federal Council press release

11.05.2026

Clinical trials of medicinal products and ATMPs with multiple sponsors

Compliant implementation

01.04.2026

New: FAQs – Questions and answers on the risk management of human medicinal products

Swissmedic is supplementing its existing guidance documents with a structured collection of FAQs on key requirements and procedures relating to the risk management of human medicinal products

13.03.2026

Protection against designer drugs: Further psychoactive substances prohibited

New synthetic drugs can harbour considerable health risks

01.03.2026

Changes to the Guidance document Product information for human medicinal products

Swissmedic specifies the requirements for the presentation of undesirable effects and interactions and adds information on environmental and disposal aspects

01.03.2026

Requirements for the authorisation of inhaled and topical preparations with known active substances in the indications asthma and/or chronic obstructive pulmonary disease

(COPD)

01.03.2026

Changes to the Guidance document Authorisation human medicinal product under Art. 13 TPA

Update of the Guidance document Authorisation human medicinal product under Art. 13 TPA

01.03.2026

Authorisation of biosimilars in Switzerland

Swissmedic's stance regarding the EMA Draft Reflection paper on a tailored clinical approach in biosimilar development

17.02.2026

Authorisations of human medicinal products with a new active substance and additional indications 2025

40 human medicinal products with new active substances authorised

16.02.2026

Illegal imports of medicinal products in 2025: more consignments, new products trends and increasing shipments from the EU

17 percent more illegal imports of medicinal products recorded than in 2024

01.02.2026

Updating of Annex 7 TPLRO – Revised list of variations

A revised list of variations according to Articles 21-24 TPO comes into force on 1 February 2026

01.02.2026

Changes to the Guidance document Drug Safety Signals HMP and the Signal Notification Form

The Guidance document Drug Safety Signals HMP has been comprehensively revised, its structure has been modified and its content has been clarified; in parallel, the Signal Notification Form has been revised and adapted to the new requirements

30.01.2026

Swiss Pharmacopoeia

from recipe book to mandatory quality standard

30.01.2026

Market surveillance of medical devices

Results of a Swissmedic focus campaign of importers

15.01.2026

Redundancy scheme for announced headcount reduction at Swissmedic approved

Agreement will permit socially acceptable implementation of staff reduction

13.01.2026

Reassessment of the safety of blood transfusions with regard to vCJD

New blood donation criteria from Swiss Transfusion SRC effective 1 February 2026

Last modification 22.11.2022

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