What changed?
Swissmedic has introduced a new authorisation pathway for herbal medicinal products with orphan drug status. This change aims to facilitate the approval process for these products, which are intended to treat rare diseases.
Who is affected?
The new authorisation pathway affects manufacturers and distributors of herbal medicinal products with orphan drug status. These companies must now comply with the revised regulations and guidelines set forth by Swissmedic.
Key requirements
The new authorisation pathway requires manufacturers to submit additional documentation, including clinical trial data and proof of orphan drug designation. Swissmedic will also conduct more frequent inspections and monitoring of these products.
Frequently Asked Questions
- Q: What is the new authorisation pathway for herbal medicinal products with orphan drug status?
A: The new pathway is a revised approval process for these products, which aims to facilitate their approval and make them more accessible to patients with rare diseases. - Q: Who is affected by the new authorisation pathway?
A: The new pathway affects manufacturers and distributors of herbal medicinal products with orphan drug status. - Q: What are the key requirements for the new authorisation pathway?
A: The key requirements include submitting additional documentation, such as clinical trial data and proof of orphan drug designation, and complying with more frequent inspections and monitoring.
Conclusion
The new authorisation pathway for herbal medicinal products with orphan drug status is a significant development in the regulatory landscape. Manufacturers and distributors must ensure compliance with the revised regulations and guidelines to bring these products to market successfully.
Disclaimer
This article is not intended to provide legal advice. Manufacturers and distributors should consult the official Swissmedic guidelines and regulations for the most up-to-date information.
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/kpa/aktuell-kpa/zl-kpa-2025.html