Swissmedic has extended the options for meetings with applicants so that the questions posed by companies in connection with the authorisation of medicinal products can be clarified together with Swissmedic in an efficient and targeted dialogue.
Swissmedic now makes a distinction between an Early and a Late Clarification Meeting.
In the Early Clarification Meeting uncertainties arising from the List of Questions can be clarified. Labelling issues in particular can be addressed in this new format so that more or less final drafts of the product information texts will ideally be available by the time of the preliminary decision.
If uncertainties about individual labelling aspects still exist after the applicant's reply to the preliminary decision of approval, Swissmedic can clarify these with the applicant during a Late Clarification Meeting. This meeting is designed to avoid additional rounds of text reviews and enable the official decision to be issued quickly.
Applicants can still apply for a Pipeline Review with a request for a Scientific Advice or Presubmission Meeting. This meeting focuses on new future applications (and extensions thereof) for which the scientific data in the late phase of development are available. Swissmedic has provided specific information about the content of the Pipeline Review in the guidance document.
Further details on applying for and conducting meetings with applicants can be found in the revised guidance document Meetings for applicants held with the Authorisation sector HMV4. The new changes take effect immediately.