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Information

15.01.2023

Changes to the guidance document Authorisation of human medicinal products under Art. 13 TPA

Application of Art. 13 TPA possible for temporary additional indications

15.01.2023

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

Extension of the time limit for finalising the decision minutes. Exchange of documentation for the AAA now possible via the eGov portal.

01.01.2023

Changes to SwissPAR HMV4 guidance document

Section 5, Clinical Assessment, of the Public Assessment Report is not part of the SwissPAR

15.12.2022

Clarification of terminology for combination products (medicinal products with a medical device component)

Current status and revision of specification documents

01.12.2022

Expansion of scope of temporary authorisations

Temporary additional indications will also be possible from 1 January 2023

01.09.2022

Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 updated

Clarification of safety-relevant updates to medicinal product information for authorisations according to Art. 14 para. 1 let. abis TPA

16.08.2022

Benchmarking study 2021

International comparison of Swiss approval times

01.08.2022

Changes to Guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4

Filing of Submission Plans to evaluate the efficacy of existing COVID-19 medicinal products against new SARS-Cov-2 variants

01.07.2022

Revision of the Therapeutic Products Licensing Requirements Ordinance

Update to Annex 7 TPLRO

01.07.2022

Changes to the Guidance document Product information for human medicinal products HMV4

Clarifications on boxed warnings and other topics

01.07.2022

Swissmedic position paper on the use of real-world evidence

Swissmedic considers real world data (RWD) as all data other than those collected through a clinical trial conducted as per ICH GCP

01.06.2022

Changes to guidance document Authorisation of human medicinal product with known active substance HMV4

ZL101_00_007e_WL

01.05.2022

Changes to guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4

Clarifications on the prioritisation and fast-tracking of pandemic medicinal products and on the patient information requirements

23.03.2022

Changes to the guidance document Formal requirements HMV4 and the form Import of a medicinal product according to Art. 14 (2) TPA (parallel import) HMV4

ZL_00_020e_WL / ZL106_00_002e_FO

25.02.2022

Authorisations of human medicinal products with a new active substance and additional indications 2021

Overview of new authorisations 2021

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Regulatory Assessment (XLSX, 265 kB, 17.01.2023)

Allocation of ATC code and IT groups KPA (XLS, 2 MB, 01.03.2022)

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