On January 10, 2026, Swissmedic announced the temporary authorization for the distribution of Xenpozyme Pulver zur Herstellung einer Lösung zur intravenösen Infusion in Taiwanese packaging within Switzerland. This regulatory decision aims to address current supply shortages and support patients who rely on this essential medication. The decision carries important implications for clinical, quality, and regulatory teams managing pharmaceutical logistics and compliance within Switzerland.
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What changed?
The temporary distribution authorization specifically enables Xenpozyme, a medication typically utilized to address specific health conditions through intravenous infusion, to be marketed and distributed within Switzerland in its Taiwanese packaging. This decision reflects Swissmedic’s commitment to ensuring a steady supply of critical pharmaceutical products amid global supply chain challenges. The shift prioritizes patient access over packaging conformity while maintaining safety and efficacy standards.
Who is affected?
This measure primarily impacts healthcare providers who administer Xenpozyme, as well as the patients depending on this treatment. Regulatory compliance teams must ensure adherence to Swissmedic’s guidelines regarding the use of imported Taiwanese packaging.
Quality assurance teams may need to verify that the Taiwanese packaging meets the relevant standards and fulfills all safety requirements, considering potential language and format discrepancies. Furthermore, caregivers and clinicians should remain aware of this development to minimize any confusion regarding the product’s appearance.
Regulatory guidance
Swissmedic has provided a clear framework to regulate this temporary measure. It ensures that products distributed under this authorization strictly meet safety and performance requirements equivalent to standard Swiss packaging. Pharmacies and hospitals receiving these Taiwanese-packaged products are expected to take additional steps to reassure healthcare professionals and patients, ensuring transparency in their use and origin.
Healthcare institutions are advised to maintain robust documentation of the Taiwanese-packaged drugs in stock to facilitate traceability and compliance. Organizations must prioritize effective internal communication on this change, emphasizing that the product itself remains unchanged apart from the external packaging.
FAQ
1. Why is Swissmedic allowing Taiwanese packaging for Xenpozyme?
This decision addresses supply chain challenges impacting the availability of Swiss-packaged Xenpozyme. The temporary authorization ensures patients have uninterrupted access to this vital medication.
2. Does this affect the medication itself?
No. The change only affects the external packaging, while the medication remains the same, maintaining its safety and efficacy profile.
3. How will this impact hospital and pharmacy staff?
Pharmacy and hospital teams should adjust processes to handle Taiwanese packaging and clearly inform healthcare providers of this temporary measure.
Conclusion
Swissmedic’s temporary authorization underscores its proactive stance in maintaining patient care during supply shortages. Regulatory and healthcare teams should align their processes with these directives to ensure compliance and effective communication with stakeholders. Xenpozyme will remain available, with only its packaging temporarily modified.
Disclaimer
This article is intended for informational purposes for clinical, quality, and regulatory professionals. It does not constitute legal advice. Please refer to official guidance for compliance requirements.
Swissmedic official link
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/out-of-stock/approved-applications/out-of-stock-xenpozyme-pulver-loesung-intravenoesen-infusion.html