This guidance explains the various types of agents that could be used maliciously and the medicines that can be used to prevent or treat their effects.

Biological agents

The Agency has created two resources giving information on medicines that can be used to prevent or treat the effects of biological agents:

  • a database of scientific information on pathogenic agents that might be used in biological warfare;
  • information on the existence of vaccines and other medicines available to prevent or treat their effects.

At the request of the European Commission, EMA has published guidance on the use of medicines for the treatment and prevention of biological agents. EMA published the first version in 2002 and has updated the guidance regularly since then:

Disease categorisation

The agents in the Agency guidance fall into three categories. These are described in the table below, compared with the categories applied by the United States Centers for Disease Control and Prevention (CDC):

European Medicines Agency categoriesCDC categories
I Major infectious diseases for which treatment exists
Anthrax, plague, tularemia, smallpox, viral haemorrhagic fever, botulism, brucellosis, Q fever, glanders, melioidosis.

II Other bacterial infections for which treatment exists
Psittacosis, epidemic typhus (Rickettsia prowazekii), tuberculosis, shigellosis, salmonellosis, cholera.

III Biological agents for which currently no specific treatment can be recommended
Enterohaemorrhagic Escherichia coli, cryptosporidiosis, viral encephalitis (Venezuelan equine encephalitis, Eastern equine encephalitis, Western equine encephalitis), nipah virus, additional viral haemorrhagic fevers (tick-borne encephalitis virus, yellow-fever virus, hantavirus, marburg and ebola virus), staphylococcal enterotoxin B, Clostridium perfringens epsilon toxin, ricin toxin.

Category A diseases/agents
Organisms that pose a risk to national security because they can be easily disseminated or transmitted from person to person, result in high mortality rates and have the potential for major public health impact, might cause public panic and social disruption, and require special action for public-health preparedness.

Category B diseases/agents
Agents that are moderately easy to disseminate, result in moderate morbidity rates and low mortality rates, and require specific enhancements of CDC's diagnostic capacity and enhanced disease surveillance

Category C diseases/agents
Emerging pathogens that could be engineered for mass dissemination in the future because of availability, ease of production and dissemination, and with potential for high morbidity and mortality rates and major health impact.

Chemical agents

The Agency has produced guidance on the medicines that can be used to treat patients who have been exposed to chemical agents during terrorist attacks. It includes:

  • general information on emergency treatments such as decontamination of victims, and principles of treating symptoms for the purposes of basic life support;
  • summary information on the main classes of specific agents of chemical warfare including how they are named, routes of exposure, toxicity, clinical symptoms and possible treatments.

EMA published the guidance in April 2003:

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