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SwissMedic Guidance: Orphan Drug, New Active Substance & Prior Notification

Swissmedic recently (02 June 2023) released multiple important guidelines that have captivated the audience and generated significant interest.

An orphan drug is a medicinal product that prevents or treats a life-threatening or chronic debilitating disease which, at the time the application is submitted, affects no more than 5 in 10,000 people in Switzerland.


The guidance document covers multiple aspects concerning Orphan Drug Status (ODS), including requirements for submitting an ODS application, the recognition process, transfer and withdrawal of ODS, and more. It also provides information on the application process for authorizing medicinal products with ODS specifically designed to treat rare diseases.


The objective of this guidance is to outline the specific requirements regarding documentation for the submission and authorization of human medicinal products containing new active substances. By publishing this document, Swissmedic aims to provide clear and transparent information to third parties about the necessary requirements that must be met in accordance with Swissmedic's practices. Guidance: Authorisation of Human Medicinal Product with known Active Pharmaceutical Substance

The purpose of this guidance document is to outline the specific requirements for submitting documentation related to the authorisation of human medicines with known active pharmaceutical ingredients (known APIs). The aim is to provide clear instructions on the conditions and requirements for both the application submission and authorization process of these medicines in Switzerland.


The guidance document provides a comprehensive description of the entire process for conducting a Procedure with Prior Notification (PPN). It covers the conditions starting from the initial request, reviewing the request, and the necessary preparatory work.

Also, the guidance outlines the steps involved in submitting the PPN application and the corresponding criteria that need to be met throughout the process.


Also, there were multiple guidelines that were released click the below LINKS respectively to know more in detail

1. Guidance: Criteria Annexes 4–10 KPTPO (Ordinance of the Swiss Agency for Therapeutic Products)







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