Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines

The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the temporary authorization of human medicinal products.

In the document, Swissmedic outlines the process for seeking temporary authorization, a path to market that allows organizations to sell a medicine for up to two years despite lacking complete documentation. Switzerland uses temporary authorization to accelerate access to treatments for life-threatening diseases, enabling patients to receive therapies while the developer works to meet the full approval requirements.

Swissmedic recently updated its advice on temporary authorizations, publishing version 13.0 of the guidance and revising an associated question-and-answer document. Most of the advice is unchanged, meaning the focus remains on the requirements and submission process for temporary authorization, but Swissmedic has clarified its position on several points.

The temporary authorization pathway is only open when there is no alternative or equivalent medicinal product authorized in Switzerland in the target indication. Swissmedic used the update to its guidance to reduce potential confusion about when it deems a product to be “authorized.” A product is authorized if it has come to market via the standard procedure or been converted from a temporary authorization.

Swissmedic has also harmonized its application deadlines for temporarily authorized medicinal products. The change means companies need to submit all documentation to Swissmedic at least 90 days before the expiration of a temporary authorization, regardless of whether they want to remove the conditions on their authorization, apply for an extension, or request a waiver.

Officials also made a terminology change. Previously, Swissmedic used the term “ordinary authorization” to refer to the standard approval that companies can seek if they fulfill the requirements set by the agency. Now, Swissmedic has changed to the term to “authorization without special conditions.” Products converted from temporary authorizations will now be deemed to have authorization without special conditions.

The changes are reflected in an updated question-and-answer document. Swissmedic has revised four of its answers and responded to two new questions about the conversion of temporary authorizations.

In response to one question, Swissmedic explained that it is not possible to convert a temporary authorization to an export license. The agency justified its position on the grounds that a therapeutic can only be temporarily authorized if “no authorized, alternative or equivalent medicinal product is available in Switzerland.” Swissmedic underlined “in Switzerland” to show the law only applies to local use.

The second new question addresses what happens to therapeutics with temporary authorization when an equivalent product is eligible for conversion to an authorization without special conditions. In that situation, Swissmedic will not allow the companies to apply to extend the temporary authorizations of the equivalent products. Swissmedic could still extend the authorization itself in some circumstances.

“Swissmedic may require more than the remaining time until expiry of the temporary authorization to review the documentation on the fulfillment of conditions,” the agency wrote. “It therefore extends the temporary authorization as necessary following receipt of the documentation on the fulfillment of conditions.”

Swissmedic guidance

Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines

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