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Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals

Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (26 May 2023) the "Guidance document Minimising the risk of TSE" and "Guidance document Authorisation Radiopharmaceutical" in Switzerland.


This guidance document describes ways of minimising the risk of passing on TSE of animal origin in human and veterinary medicinal products


Transmissible Spongiform Encephalopathies (TSEs) are a group of neurodegenerative diseases that affect humans and animals. These diseases are caused by abnormal proteins called prions, which can accumulate in the brain and cause damage.


There is a risk of transmission of TSE for authorised medicinal products as well as medicinal products that need to be approved. It is important to take into account the country of origin of the animals, their feeding practices, the tissues or organs that are used and the way in which they are processed (manufacturing process), the route of administration, the quantity of tissue, the therapeutic dosage, and the intended use of the medicinal preparations.


The form Substances of animal and human origin HMV4 must be completed and submitted (particularly part A of the form for TSE substances). Click this LINK to know more about the scope, declaration etc.



Radiopharmaceuticals (radiodiagnostic agents and radiotherapeutic agents) are medicinal products containing radionuclides whose radiation is used for diagnostic or therapeutic purposes.


Swissmedic uses this guideline document first and foremost for applying the legal provisions in a uniform and equitable manner, as it outlines the specific requirements relating to the authorisation of radiopharmaceuticals in Switzerland. To make authorisation applications as swift and efficient as possible, an applicant must meet the specific requirements outlined in the document.


Radiodiagnostic agents' authorization, extension, and modification (major variants, type II) is usually reviewed by the ECRP, which prepares the assessment reports (AR).


Click this LINK to know more in-depth about the Principles of review and general requirements, etc.



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