"EU legislation foresees that conditional marketing authorisation is used as the fast-track authorisation procedure during public health emergencies to speed up approval and save lives."
Procedures have been put in place in the European Union to speed up the availability of vaccines that can be used to protect the population against pandemic influenza.
These procedures, managed by the European Medicines Agency, allow an influenza vaccine to be authorised more quickly than the 18 to 24 months usually required for the authorisation of a medicine in the EU.
The two main procedures for authorisation of pandemic influenza vaccines are:
- the 'mock-up procedure', which allows a vaccine to be developed and authorised in advance of a pandemic, based on information generated with a virus strain that could potentially cause a pandemic. Once the actual virus strain causing the pandemic is identified, the manufacturer can include this strain in the mock-up vaccine and apply for it to be authorised as a 'final' pandemic vaccine;
- the 'emergency procedure', which allows for fast-track approval of a new vaccine developed after a pandemic has already been declared. Authorisation of these pandemic vaccines is quicker than for a normal vaccine, as the information submitted by the manufacturer is assessed in an accelerated timeframe (around 70 days instead of 210 days).