The new article highlights the aspects related to the review of the application by the authority and regulatory decisions the authority may take based on the results of such a review.
Table of Contents
The Swiss regulatory agency in the sphere of healthcare products, Swissmedic, has published an information sheet dedicated to performance studies involving in vitro diagnostic (IVD) medical devices. The document provides an overview of the existing regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance itself are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Furthermore, the authority reverses the right to make changes to the document and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the submission of the initial application for authorization for interventional performance studies.
Application Review
According to the document, the authority will conduct a rigorous review of the application submitted, assess carefully the information contained therein, and get back to the applicant with its decision. It is important to mention that in the course of the application review or after it, the authority may request additional information to be provided by the applicant, should this be reasonably required for the authority to assess all the aspects associated with the investigation in question. Should a positive decision be taken by the authority, the applicant will be notified accordingly, while the authority will remain pending for the decision of the cantonal ethics committee – under the general rule, Swissmedic is entitled to grant authorization for a performance study only provided the study is approved by the respective ethics committee.
Rejections, Restrictions, and Conditions
The document also addresses matters related to alternative scenarios. As explained by the authority, in the case when a positive decision cannot be taken, a preliminary decision will be issued no later than 45 days from the date when the authority has initially acknowledged the receipt of the application. In some cases, the authority may need additional time to review the submission, so the review timeframe could be extended to 65 days (for instance, in case of first-in-human investigations or manufacturing using a new procedure). However, it is important to mention that the review timeframe for a cantonal ethics committee should be calculated separately. Each of the authorities and the ethics committee would send separate letters to the applicant.
The aforementioned preliminary decision will contain the details about the grounds for rejection, restrictions, or conditions and also outline information that is missing and should be provided by the applicant in order for the review process to be completed.
The applicant should review the deficiencies identified during the initial application review and provide missing information and documentation within 30 calendar days. It is important to mention that exactly the same information should be provided the same dame to both the authority and the ethics committee involved.
If additional clarification or guidance is required, an applicant may contact the authority and ask for further assistance. If the deficiencies identified cannot be reasonably addressed within the aforementioned timeframe, the interested party may either request an extension or retract the application.
Once the application is retracted or rejected, an interested party can submit a new one at any time.
Combined Clinical Trials
According to the guidance published by Swissmedic, in combined trials, both IVD (typically companion diagnostics) and medicinal products or advanced therapy medicinal products (ATMP, transplant products) are subject to investigation. The authority also emphasizes that the requirements for clinical trials with medicinal products and those for interventional performance studies with IVD must be fulfilled.
Radioactive Substances
In the case of performance studies involving radioactive substances, the requirements set forth under the Swiss Radiological Protection Ordinance should be followed by all the staff involved, while the appropriate permit from the Federal Office of Public Health will also be required. The document also recommends that interested parties to contact the Radiation Protection Office of the above authority for further guidance. When submitting an application for Swissmedic for such an investigation, an applicant should provide the aforementioned authority in order for the application to be accepted for review (could be submitted either in original or as a copy).
Fees
The document also outlines the fees payable by the applicant with respect to the submission. According to the document, the fees as of April 2023 are:
- Flat rate fee for handling an application for the authorization of a clinical investigation with a medical device – CHF 5000 (regular review) and CHF 1500 (simplified review);
- Additional work will be charged at a rate of CHF 200 per hour (for instance, in case of corrections are required).
In summary, the present information sheet issued by Swissmedic highlights certain aspects related to the review of an application for authorization of a clinical investigation an interested party should obtain to be allowed to conduct a trial. The document describes in detail the regulatory procedures associated with the review, including the decisions the authority may take and the consequences thereof.
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