EMA releases procedural guidance for flu vaccine applications
Aims to speed up approvals in the event of a pandemic
The European Medicines Agency (EMA) has released new guidance on authorising influenza vaccines that aims to hasten approvals during pandemics.
Sparked by concerns about tardy responses by medicine regulators during the 2009–2010 swine flu pandemic, the guidance covers market authorisations for pandemic, pre-pandemic and seasonal flu vaccines, as well as responding to changes in flu viruses.
EMA said the agency had conducted a 'lessons learned' exercise after the 2009–2010 outbreak and since then gained experience through scientific advice and flu vaccine marketing authorisation applications.
This highlighted the need for more comprehensive guidance 'that covers the regulatory, quality, non-clinical and clinical aspects of influenza vaccine development and dossier submission,' said EMA.
As regards responding to a pandemic recognised by the World Health Organisation (WHO) or the European Union (EU), the guidance stresses 'the evaluation will be accelerated as appropriate', as will final authorisation decisions by the European Commission.
The advice says EMA accepts that during a pandemic, 'it may be difficult to generate a comprehensive dossier' when making a market approval application. 'A submission of a MAA based on a non-comprehensive dossier under the conditional marketing authorisation may therefore be considered if the applicant is likely to be in a position to provide the comprehensive clinical data after the declaration of a pandemic,' the EMA said. Such data may be included in a dossier later.
Similar expedited procedures are available if a virus mutates during a pandemic, with the guidance stressing that pharma manufacturers should ensure 'an efficient interaction with the EMA Pandemic Task Force (ETF) to discuss critical issues in advance of the submission.'