SFL authors article in RAPS on pathways for innovative medicines in Switzerland
The Regulatory Affairs Professionals Society (RAPS) published an article (paywall) co-authored by SFL’s Head Global Regulatory Affairs and Deputy CEO Anja Bührer, Senior Regulatory Affairs Manager David Berner and CEO Shayesteh Fürst-Ladani, on 31 August 2021.
Entitled ‘Regulatory pathways for innovative medicinal products for Switzerland’, the article provides a comprehensive overview of Swiss marketing authorization pathways for medicinal products with a new active substance.
The article presents the Swiss regulatory framework and outlines key characteristics and eligibility criteria for different procedures available for products with new active substance:
- Standard marketing authorization procedure: this is the regulatory pathway generally accessible for products with new active substance, with a review timeline from Swissmedic of 330 days;
- Fast track procedure: this pathway is reserved for medicinal products with expected high therapeutic benefit addressing unmet medical needs. If Swissmedic agrees that the eligibility criteria are fulfilled, the fast track route allows for an accelerated assessment with reduced Swissmedic review timeline of 140 instead of 330 days;
- Temporary authorization: this type of authorization can be granted for medicinal products for the treatment of life-threatening diseases based on an incomplete set of clinical data. The review timeline is also reduced to 140 days and the authorization is valid for two years. To be eligible for the procedure, medicinal products must fulfill a series of strict conditions;
- Prior notification procedure: the Swissmedic review timeline can be reduced to 264 days if the company informs about the intended filling well in advance and if Swissmedic agrees to this procedure;
- Authorization via Article 13 of the Therapeutic Products Act (TPA): certain medicinal products (e.g. FDA/EMA-approved Orphan Drugs, products for transmissible infectious diseases) already authorized in recognized countries can be authorized by a facilitated procedure considering the results of the assessment of the reference authority.
The article also explores the possibilities for simultaneous submission and review of marketing authorization applications (MAAs) on the basis of collaboration between Swissmedic and other regulatory health authorities (Access Consortium, Project Orbis).
The article furthermore outlines strategic considerations to be taken into account when choosing marketing authorization procedure to ensure an efficient and timely market access.