The swissmedic recently on 1st July, 2024 updated and shared two guidances "Guidance: Formal Requirements" and "Guidance: SwissPAR".
The Swissmedic guidance on formal requirements provides comprehensive instructions for the preparation and submission of applications related to medicinal products.
This guidance ensures that all submissions meet the necessary formal criteria, thereby facilitating efficient processing and evaluation by Swissmedic. The guidance outlines the mandatory formal requirements for all types of submissions to Swissmedic, including marketing authorization applications, variations, and renewals.
This guidance applies to all submissions to Swissmedic, Submissions must adhere to the following general principles:
Language: Documents should be submitted in one of the official Swiss languages (German, French, Italian) or in English.
Format: Electronic submissions are preferred. If hard copies are submitted, they must be legible and well-organized.
Completeness: All required documents and information must be included in the submission package.
Structure: Submissions should follow the specified format, with clear headings and logical organization.
The guidance includes annexes providing templates, checklists, and additional resources to aid applicants in preparing their submissions. Adhering to these guidelines helps applicants avoid delays and improve the likelihood of successful submission outcomes.
The Swiss Public Assessment Report (SwissPAR) is a summary, public evaluation report drafted by Swissmedic that relates to an authorisation procedure. The SwissPAR is produced for all human medicinal products with a new active substance and transplant products for which a new authorisation application has been approved or rejected by Swissmedic.
The purpose of this guidance is to demonstrate the principles on which Swissmedic creates and publishes SwissPARs. This guidance serves to establish a consistent practice relating to procedures and the creation and publication of SwissPARs and Public Summary SwissPARs.
For further details, refer to the full draft document available here.
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