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

Application of Art. 13 TPA possible for temporary additional indications


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.


Changes to SwissPAR HMV4 guidance document

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


Expansion of scope of temporary authorisations

Temporary additional indications will also be possible from 1 January 2023


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


Benchmarking study 2021

International comparison of Swiss approval times


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


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

Clarifications on boxed warnings and other topics


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


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