10.05.2017 - The two SMEC committees – the Human Medicines Expert Committee (HMEC) and the Veterinary Medicines Committee (VMEC) – support Swissmedic by providing expert reports and advice on the scientific assessment of documentation relating to the authorisation, market surveillance and approval of medicinal products.
In a pilot phase, Swissmedic will now be publishing the dates of the 12 HMEC and 6 VMEC meetings held each year. This will help to optimise the authorisation process for the applications processed by the SMEC committees as it will provide applicants with further information for planning their submissions and replying to the List of Questions.
With the fast-track authorisation procedure (BZV) in particular, it is important that the replies submitted are checked and the preparations for the HMEC meeting during evaluation phase II dealt with swiftly within the tight time-window available.
With the BZV, this is the case if at least 40 calendar days elapse between receipt of the answer to the List of Questions by Swissmedic and the fixed HMEC date. If the timespan is shorter, HMEC can only make the recommendation at the next meeting but one; the deadline is then in danger of being missed. Publication of these dates on a trial basis will additionally improve transparency.