The new article provides further clarifications regarding the authorisation procedure to be followed by the parties interested in conducting combination studies in Switzerland.
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Swissmedic, the country’s regulatory agency in the sphere of healthcare products, has published a information sheet dedicated to combination studies. The document provides an overview of the applicable regulatory requirements set forth under the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers, study sponsors, and other parties involved.
At the same time, the authority reserves the right to make changes to the document and information provided, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Authorization of Combined Studies: Key Points
In accordance with the applicable legislation, authorization from Swissmedic is required for combined studies that include the following elements:
- Category B or C clinical trial of a Medicinal Product (MP) / Advanced Therapy Medicinal Product (ATMP): This aspect is referred to as the MP/ATMP aspect of the combined study.
- Category C clinical investigation of a Medical Device (MD) or performance study of an In-Vitro Diagnostic Medical Device (IVD): This aspect is referred to as the MD/IVD aspect of the combined study.
If there is any uncertainty regarding the categorization of study components, sponsors should consult the cantonal ethics committee. For questions related to ATMP aspects of combined studies, the Division of ATMP at Swissmedic should be contacted.
Applying for Authorization of a Combined Study
The application for authorization of combined studies must be submitted simultaneously to Swissmedic and the responsible cantonal ethics committee on the same day. The submission is done through the eGov Service eMessage portal, using a single submission package called eDok.
Information on preparing and submitting the eDok can be found in annex A6 of the information sheets BW600_00_015e_MB and BW600_00_016e_MB. The document further provides additional clarifications regarding the content of submissions and its key components.
In particular, the authority explains that:
- Folders 00.00 – 17.00: These folders should contain the documentation for the MD/IVD aspect of the combined study, including the relevant form (BW610_10_026e_FO for MD aspects or BW610_10_027e_FO for IVD aspects). If the study has multiple protocols, these should be placed in sub-folder 04.00. Cover letters, decisions from ethics committees, or foreign competent authority decisions should be placed in folders 01.00, 02.00, and 03.00, regardless of whether they pertain to the MD/IVD or MP/ATMP aspects.
- Folder 18.00: This folder should contain documentation related to the MP/ATMP aspect, including the relevant FO submission form.
Review and Authorization Process
The application will be reviewed by experts at Swissmedic responsible for the MD/IVD and MP/ATMP aspects. During or after the review process, Swissmedic may request additional information or clarification from the sponsor.
If a positive decision is reached based on the submitted documents, Swissmedic will inform the sponsor and await the decision of the cantonal ethics committee. Swissmedic is only able to authorize a combined study after receiving approval from the cantonal ethics committee, as required by the ClinO-MD provisions.
Upon approval from the ethics committee, Swissmedic will issue an authorization letter, which includes:
- Authorization of the clinical trial of the MP/ATMP (based on the ClinO regulations).
- Authorization of the clinical trial of the MD/IVD (based on the ClinO-MD regulations).
Submission in Case of More Than One Sponsor
In exceptional cases, a combined study may have more than one sponsor. In such cases, all sponsors should be listed on the application form BW610_10_026e_FO or BW610_10_027e_FO.
Swissmedic will send all communication to the sponsor (or their representative) listed first on the application form.
Submission in Case of Confidentiality Restrictions
If the individual making the main submission to Swissmedic does not have access to certain documents due to confidentiality restrictions, these documents can be submitted separately in a second submission.
The following steps should be taken in such cases:
- Describe the situation in the cover letter of the main submission, listing the affected documents and indicating how many additional submissions are planned, along with the anticipated submission date.
- Select the appropriate tick box indicating that confidentiality restrictions affect the submission on form BW610_10_026e_FO or BW610_10_027e_FO
- Upload the main eDok and wait for the acceptance of delivery confirmation.
- The entity submitting the confidential documents must:
- Prepare a second eDok containing the confidential documents.
- Fill out form BW610_10_028e_FO, including the delivery ID from the acceptance of delivery confirmation received for the main submission.
- Include form BW610_10_028e_FO in the second eDok.
If the confidential documents pertain to the MP aspect of the study, the relevant FO submission form should be included in folder 18.00. It is important to note that the formal review of the submission will only begin once all documents have been received and the submission is complete.
If Swissmedic identifies deficiencies or has questions regarding the confidential documents, it will contact the person or entity listed on form BW610_10_028e_FO directly. All other communication will be directed to the primary sponsor or their representative.
Conclusion
In summary, the process of obtaining authorization for combined studies from Swissmedic is detailed and requires close coordination with both Swissmedic and the cantonal ethics committee. It involves submitting a complete and well-organized eDok package and ensuring that all required documentation is in place. In special cases, provisions exist for multiple sponsors and confidentiality restrictions, but these must be carefully managed to avoid delays in the authorization process.
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