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01.10.2026

Changes to the Guidance document “Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)”

Swissmedic has updated the Guidance document on parallel imports. In particular, the changes concern clarifications on country of export, additions to the requirements for packaging, storage instructions and information on handling in the medicinal product information for parallel imported medicinal products

01.10.2026

Revision of the Guidance document Authorisation Biosimilar

Following finalisation of the EMA Reflection paper on a tailored clinical approach in biosimilar development, the Guidance document Authorisation Biosimilar has been adapted accordingly

01.09.2026

1 September 2026 – New: FAQ on Swissmedic Fees Ordinance

New: FAQ – Frequently Asked Questions on the Swissmedic Fees Ordinance (FeeO-Swissmedic; SR 812.214.5)

01.08.2026

Changes to the questions and answers and guidance document on mobile technologies

Swissmedic has revised the guidance document “Mobile technologies” and the “Questions and answers on mobile technologies” and clarified the requirements on the use of QR codes on medicinal product packaging

01.08.2026

Updating of the information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway

The changes take account of the completed changeover of the reporting process via the gateway from E2B(R2) to E2B(R3) and the requirements of GVP Module VI Addendum II

01.08.2026

Changes to the guidance document RMP ICH E2E information submission HMP

New framework conditions for the central electronic publication of officially mandated information materials.

01.07.2026

TPLRO, TPLO: Update of annexes

Update of the TPLRO and TPLO annexes

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

01.06.2026

Changes to the Project Orbis guidance document

Project Orbis guidance document updated

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

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

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Regulatory Assessment (XLSX, 269 kB, 17.08.2026)

Allocation of ATC code and IT groups KPA (XLSX, 256 kB, 23.09.2026)

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