The European Medicines Agency (EMA) has released a concept paper for a three-month consultation period on revising its influenza vaccine guidance. The paper seeks stakeholders’ views on the need to revise the series of guidelines in place regarding regulatory requirements for the clinical, non-clinical and quality development aspects of influenza vaccines.
The need to update the guidelines was recognized by the agency during and after the 2009-2010 influenza pandemic.
The concept paper also points to need to consider the regulatory expectations that would apply to novel influenza vaccines based on recombinant proteins, virus-like particles (VLPs), DNA or live viral vectors.
Feedback can be submitted until the end of December. Once all feedback has been reviewed, the agency will “start the revision of the guidelines as appropriate,” according to the agency announcement.