Updating of guidance document on authorisation of human medicinal products under Art. 13 TPA HMV4

Changed procedure for "Justified cases" pursuant to Art. 18 para. 2 TPO


In application of Art. 13 TPA1 in conjunction with Art. 18 para. 2 TPO2, Swissmedic may, on request and to an appropriate extent, scale back the scientific assessment of applications for the authorisation of – or extensions of the indications of – innovative human medicinal products. In addition to medicinal products that have been classified as an orphan drug and duly authorised by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) or by the U.S. Food and Drug Administration (FDA) under the Orphan Drug Act, as of 1 January 2020 Swissmedic is also applying this practice to applications relating to medicinal products which are intended to prevent a transmissible infectious disease that may cause severe harm or serious suffering with potentially fatal consequences.

The relevant guidance document has been updated and supplemented accordingly – cf. in particular section 7.2, ‘Streamlined review procedure on request for special medicinal product categories’. As with the procedure for orphan drugs, Swissmedic will scale back its own assessment in the light of foreign test results, provided the medicinal product has been authorised by the European Commission or the FDA and the indication to which the application relates is the same as that already approved by the reference authority.

With this more liberal application of Art. 13 TPA, Swissmedic is helping to improve primary prevention and thereby contributing to the protection of public health.


1 Therapeutic Products Act (TPA; SR 812.21)
2 Ordinance on Therapeutic Products (TPO; SR 812.212.21)