News about GMP/cGMP

25.02.2021

Swissmedic: Permanent participation in "Orbis"

Swissmedic: Permanent participation in "Orbis"

On 17 February 2021, Swissmedic announced that it will now permanently support the "Orbis" project. Orbis enables manufacturers to submit their marketing authorization applications submitted to the US FDA simultaneously to other international regulatory authorities, provided they participate in the project.


The goal of the project, initiated by the US FDA's Oncology Center of Excellence (OCE), is to accelerate the marketing authorization process for new cancer therapies worldwide.   

The applications submitted for marketing authorization are reviewed in cooperation with the FDA. Innovative therapeutic approaches thus reach the market and are made available to patients more quickly. Swissmedic participated in the project in 2020 in a pilot trial.  

As of March 1, 2021, the new Orbis HMV4 project guideline will come into force, describing the conditions for participation and the processes.   

Declarations of consent are required for the exchange of information between the FDA and the other authorities. For this purpose, you will find an updated version of the following forms on the Swissmedic website, also from 1 March:  

  • New authorisation of human medicinal products HMV4 
  • Variations and extensions HMV4  

In addition to Swissmedic, Health Canada, Japan's PMDA and the Australian regulatory authority TGA are also involved in the project.


Sources:

Swissmedic: Swissmedic permanently involved in Project Orbis

Swissmedic: ZL000_00_048e_WL Guidance document Project Orbis HMV4

US FDA: Project Orbis


 

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