top of page

Swissmedic Guidance: Formal Requirements and SwissPAR

Writer's picture: Sharan MuruganSharan Murugan

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.

Comments


I Sometimes Send Newsletters

Thanks for submitting!

  • LinkedIn
  • Facebook
  • Twitter
  • Instagram

DISCLAIMER

The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

bottom of page