08.04.2019
Publication of time windows for submitting replies to the List of Questions for applications in the fast-track and temporary authorisation procedures
In order for applications in the fast-track authorisation procedure to be processed promptly, applicants previously needed to submit their answers to the Swissmedic List of Questions (LoQ) at least 40 calendar days before the date of the Human Medicines Expert Committee (HMEC) meeting (Swissmedic Journal 03/2017). In practice, it has been shown that this requirement needs to be more precisely defined for applications in the fast-track authorisation procedure. Also, due to the revision of the Therapeutic Products Act (TPA2), the scope should be extended to include the temporary authorisation procedure.
In future, a six-day submission window – 43 to 37 calendar days before the published HMEC date – must be factored in for the submission of answers to the LoQ for both procedures in order to ensure that applications are processed efficiently and promptly. The HMEC meetings published on the Swissmedic website will in future be supplemented by details of the time windows for replies to the LoQ. Once published on the Swissmedic website, the time windows for applications in the fast-track/temporary authorisation procedures must also be taken into account by applicants in the event of any extension requests.