The first revision of the guidance document Project Orbis HMV4 largely involves linguistic clarifications and editorial adaptations. The inclusion of the Israeli regulatory authority in Project Orbis should be noted as a substantial change (see list in section 2). The participation of the Israeli authority also required an addition to the declaration of consent to the exchange of information with the U.S. FDA, as well as the partner authorities involved in Project Orbis, in the forms New authorisation of human medicinal product HMV4 and Variations and extensions HMV4.
An annex (Annex 1) has also been added to the guidance document Project Orbis HMV4. This contains a flow chart of the most important process steps when requesting an Orbis application, from the selection criteria for the Orbis type through to Swissmedic's official decision.
The revised guidance document Project Orbis HMV4 and the corresponding form take effect on 1 September 2021.