This section provides information about the role and activities of the European Medicines Agency in relation to pandemic influenza. It also provides information on the development and approval of medicines for use in the European Union (EU) during pandemics.
Pandemic influenza occurs when a new strain of influenza (flu) virus emerges that can spread easily from person to person. It is different from the normal ‘seasonal’ flu, because the strain is new, and because people have no protection or 'immunity' against it. Because of the lack of immunity, the virus can spread widely across the world.
The consequences of a flu pandemic can be serious, in terms of both public health and economic costs. Four pandemics have occurred since the beginning of the 20th century: ‘Spanish influenza’ in 1918, ‘Asian influenza’ in 1957, ‘Hong Kong influenza’ in 1968 and the 2009 (H1N1) pandemic in 2009-10.
There are two types of medicine used in the prevention and treatment of pandemic influenza:
- vaccines, which are one of the most effective means for preventing people contracting flu;
- antiviral medicines, which can be used either to prevent people contracting flu or to treat them once they have contracted it.
Role of the Agency
Influenza pandemics are announced officially by the World Health Organization (WHO) on the basis of information on the activity of flu virus around the world. The Agency is responsible for reviewing data on pandemic-influenza vaccines and antiviral medicines eligible for authorisation in the European Union (EU) via the via the centralised procedure.
The Agency has developed a pandemic influenza crisis management plan, which describes how it works during an influenza pandemic. The plan allows the Agency to respond rapidly and efficiently to the challenges of an outbreak of pandemic influenza:
- European Medicines Agency pandemic influenza crisis management plan
- Influenza pandemic process map
- Work instructions: Pandemic influenza
Once a pandemic has been announced, the Agency implements this plan. Its main activities during a pandemic are:
- the fast-track review of data for the authorisation of pandemic-influenza vaccines or use in all EU Member States;
- continuously monitoring the safety of centrally authorised pandemic-influenza vaccines and antiviral medicines;
- recommending changes to the use or authorisation status of these medicines where necessary;
- liaising with European partners, including the European Commission, regulatory authorities in EU Member States, agencies such as the European Centre for Disease Prevention and Control (ECDC), and international partners, such as the World Health Organization (WHO) and regulatory bodies of non-EU countries, to ensure timely exchange of information and co-ordination of activities relating to the pandemic;
- communicating relevant information about its activities to the public, healthcare professionals and the media.
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- World Health Organization: Pandemic influenza preparedness and response
- European Commission: Influenza pandemic preparedness
- European Centre for Disease Prevention and Control: Influenza pandemic preparedness
- Guidance for industry: Pandemic influenza