Until now, in section “1 Basic information”, subchapter ”Requested medical application/indication”, of the form New authorization of human medicinal products, companies have often indicated brief characteristics as indications in, as this information is published by Swissmedic upon receipt of the application. With the new regulation from Swissmedic, more specific information must be provided in this section as follows:
- Specification of the disease (molecular subtype if applicable)
- Target population
- Specification of the line (if applicable)
- Specification of the type of previous therapy (if applicable)
- Specification of whether monotherapy or combination with other active substances
This means that a more detailed description of the indication wording is required and short characteristics are no longer accepted in the future. Non-compliance with this requirement leads to objections already during the formal control of the application.
