Swissmedic, the Swiss Agency for Therapeutic Products, has provided guidelines on (15 May 2024) "Temporary Authorization to Use an Unauthorised Medicinal Product" which is crucial for addressing urgent medical needs when no authorized alternatives are available.
This guideline clarifies the requirements for submission of new applications for temporary authorisations for the use of an unauthorised medicinal product, as well as the requirements for submission of changes and reporting during the conduct of a temporary authorisation.
What is Temporary Authorization?
Temporary authorization allows the use of medicinal products that have not yet received full marketing authorization. This measure ensures that patients can access potentially life-saving treatments when other options are not available.
To be eligible for temporary authorization, the medicinal product must meet the following criteria:
Unmet Medical Need: The product should address a serious or life-threatening condition for which no adequate treatment exists.
Preliminary Data: Sufficient preliminary data must be available to suggest that the product is likely to be safe and effective.
Risk-Benefit Assessment: A positive risk-benefit assessment should be possible based on the available data.
This guideline covers details on the following
Timelines and application fees
New application for a temporary authorisation project
Submission of changes to an approved temporary authorisation project
Reporting during the conduct of a temporary authorisation project
Once a temporary authorization is granted, the following requirements must be met:
Ongoing Monitoring: Continuous monitoring of the product’s safety and efficacy is mandatory. This includes regular reporting of adverse events and other relevant data.
Additional Studies: The applicant may be required to conduct further studies to provide additional data on the product’s safety and efficacy.
Review and Renewal: The temporary authorization is subject to periodic review and may be renewed based on updated data and ongoing needs.
Temporary authorization can be terminated under certain conditions:
Completion of Full Authorization: If the product receives full marketing authorization, the temporary authorization ceases.
Safety Concerns: If new data emerges that significantly alters the risk-benefit balance, Swissmedic can revoke the authorization.
End of Medical Need: If the urgent medical need no longer exists, the temporary authorization may be withdrawn.
For detailed information and to access the necessary forms, you can read the full Swissmedic guidance document here.
Also, check out this recently updated guidance on "Submission Process for Clinical Trials with Medicinal Products".