Recntly Switzerland's Swissmedic provided essential information on guidance "Fast-Track Authorisation Procedure" and "Temporary Authorisation for Human Medicinal Products". These procedures are aimed at accelerating access to crucial therapies while maintaining stringent safety and efficacy standards.
Guidance: Fast-Track Authorisation Procedure
The Fast-Track Authorisation (FTA) procedure by Swissmedic is designed to expedite the review and approval process for specific human medicinal products that demonstrate a significant medical benefit. This pathway is especially useful for products intended to address severe or life-threatening conditions that lack adequate treatment options.
Products eligible for fast-track consideration must provide substantial therapeutic benefits over existing treatments, such as treating rare diseases, improving patient quality of life, or offering a new approach to disease management. The FTA shortens the review timeline by prioritizing the application throughout the assessment stages. This requires applicants to submit well-prepared, complete documentation to avoid delays.
Products approved via the fast-track route must meet ongoing regulatory requirements, including post-market surveillance to monitor safety and effectiveness. Swissmedic may request additional studies to substantiate the initial data submitted. For the full guidance, refer to the Fast-Track Authorisation Procedure.
Swissmedic’s Temporary Authorisation (TA) pathway provides conditional marketing approval for human medicinal products based on incomplete clinical data, under the condition that comprehensive data will be submitted post-approval. This pathway is crucial for therapies addressing urgent or high-priority health needs.
Temporary authorisation is based on Art. 9a TPA in conjunction with Art. 18–22 TPLO, includes as yet incomplete documentation at the time of authorisation and is granted for a maximum of two years with special conditions (Art. 21 TPLO). As part of the authorisation procedure, full documentation is required and the initial authorisation period is 5 years (Art. 16 para. 2 TPA). Authorised implies unlimited authorisation and is not subject to special conditions.
Products granted temporary authorisation are subject to stringent post-marketing obligations to ensure that they continue to meet safety standards. Swissmedic may conduct regular reviews and mandate additional studies as required. Once all required data has been submitted and reviewed, temporary authorisation may transition into a standard authorisation, assuming the product’s benefit-risk profile remains favorable.
For complete details, please refer to the Temporary Authorisation for Human Medicinal Products.
Also, check out this guidance on "Authorisation of Medicinal Gas" which describes the requirements governing the documentation obligation for the authorisation of medicinal gases in Switzerland. The guidance document is aimed primarily at administrative bodies.
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