Expert comment: Swissmedic introduces the Preliminary Decision Clarification Meeting for human medicinal products containing new active substances

In the course of the regulatory approval process, particularly for innovative products, situations often arise where a close dialogue with the authority is needed or beneficial, e.g. to clarify specific scientific issues or to agree on a certain response strategy to address (major) concerns that the authority has identified.

With the newest revision of the Guidance document Meetings for applicants for authorisation procedures, Swissmedic introduces the option to request a clarification meeting after having received the Swissmedic preliminary decision. This has been decided after a successful pilot phase. The new meeting type is available for marketing authorisation applications concerning new active substances (NAS) and their additional indications, irrespective of the regulatory procedure used.

The pharmaceutical industry appreciates further options for discussion of key issues relevant during the authorisation procedure. The new meeting option supplements the already available meeting types with Swissmedic such as meetings before submission/during development, the LoQ clarification meeting, and the labelling meeting. Further options for discussion will facilitate the timely regulatory review process and may ultimately help accelerating access to innovative treatments for Swiss patients.