While the Food & Drug Administration (FDA) and the European Medicines Agency (EMA) are the regulatory bodies of the US and the European markets, respectively, Switzerland has its own fully independent agency for therapeutic products: Swissmedic.
As described in our Swizzard Insight No. 1, Swissmedic also offers various special programs that help to improve and accelerate access to health interventions and therapeutic products in Switzerland and in multiple other countries. One of these special programs is called Orbis.
About Orbis
Project Orbis, a program aiming for faster access to innovative cancer treatments, is coordinated by the FDA. It provides a framework for the simultaneous submission and review of applications for oncology products with partner authorities in different countries, including Switzerland. The clinical criteria for selecting applications for Project Orbis by the FDA include high expected effectiveness and clinically meaningful application.
Applications for Project Orbis should meet the criteria for an FDA Priority Review. While the initial inquiry must be directed to the FDA, each country involved remains completely independent regarding the final approval decision and labeling. The approval authorities of the following countries are involved: Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Singapore (HSA), Switzerland (Swissmedic) and the United Kingdom (MHRA).
For Project Orbis, new approval applications for oncology drugs with new active ingredients and new indications (changes of type II) are possible. There are no restrictions concerning the types of procedures: applications can be submitted using standard, accelerated/fast-track procedures or by submission with prior notification.
About Swizzard Pharma AG
Swizzard Pharma AG provides a range of support services for biotech and pharma companies. Headquartered in Zug (Switzerland), Swizzard focuses on helping customers maximize the value of their medical breakthroughs in the small but highly attractive Swiss market. From setting up a smart affiliate structure and building a trusted brand to accelerating time-to-market and maximizing peak sales – four specially designed solution packages bundle Swizzard’s knowledge, experience and network to help biotech and pharma companies thrive in the Swiss market.
For further expertise on the topic, please contact us:
Swizzard Pharma AG
Corporate Competence Center
Luc Heller
luc@swizzard-pharma.com