EMA updates guidances on treatment, prophylaxis for chemical and biological agents
Regulatory News | 14 August 2024 |
The European Medicines Agency (EMA) has issued two updated guidances covering medicines used for treatment or prophylaxis in case of patient exposure to biological or chemical agents used as weapons of terrorism.
In developing the gudiances, EMA’s Emergency Task Force (ETF) consulted with over 50 experts in the toxicology, pharmacology, clinical management and military fields, and aligns with EMA's recently “reinforced mandate on managing health threats.”
The guidance on the use of medicinal products to treat patients who have been exposed to chemical agents covers general information on emergency treatments such as decontaminating victims and principles of treating symptoms for the purposes of basic life support, and summary information, such as descriptions of clinical symptoms and possible treatments, and the main classes of chemical agents that might be deliberately released.
The chemical agents covered by the guidance include blister or vesicant agents, nerve agents, cyanides, lung-damaging agents and pharmaceutically based agents. The list of substances is mainly derived from a list developed by the US Center for Disease Control and Prevention (CDC). The guidance supersedes a previous version issued in April 2003.
The guidance on the use of medicinal products for treatment or prophylaxis against biological agents includes a database of scientific information on pathogenic agents that might be deliberately released and information on the existence of vaccines and other medicines available to prevent or treat their effects.
The document was prepared at the request of the European Commission. The first version of the guidance was published in 2002 and has been updated periodically since then.
The guidance addresses Category A pathogens which are considered high-priority agents because they can be easily disseminated or transmitted from person to person, are characterized by high mortality rates, have the potential to cause major public health impact and require special attention in terms of preparedness.
Category B pathogens represent the second highest priority because they can be disseminated moderately easily, can cause moderate morbidity and require specific diagnostic capacity and enhanced disease surveillance.
Category C agents include emerging pathogens that can be engineered for mass dissemination because of their availability and ease of production. They have the potential for high morbidity and mortality rates. The guidance has been revised to align it with the current classification used by the US CDC.
EMA guidance on exposure to chemical agents
EMA guidance on treating and preventing exposure to biological agents
In developing the gudiances, EMA’s Emergency Task Force (ETF) consulted with over 50 experts in the toxicology, pharmacology, clinical management and military fields, and aligns with EMA's recently “reinforced mandate on managing health threats.”
The guidance on the use of medicinal products to treat patients who have been exposed to chemical agents covers general information on emergency treatments such as decontaminating victims and principles of treating symptoms for the purposes of basic life support, and summary information, such as descriptions of clinical symptoms and possible treatments, and the main classes of chemical agents that might be deliberately released.
The chemical agents covered by the guidance include blister or vesicant agents, nerve agents, cyanides, lung-damaging agents and pharmaceutically based agents. The list of substances is mainly derived from a list developed by the US Center for Disease Control and Prevention (CDC). The guidance supersedes a previous version issued in April 2003.
The guidance on the use of medicinal products for treatment or prophylaxis against biological agents includes a database of scientific information on pathogenic agents that might be deliberately released and information on the existence of vaccines and other medicines available to prevent or treat their effects.
The document was prepared at the request of the European Commission. The first version of the guidance was published in 2002 and has been updated periodically since then.
The guidance addresses Category A pathogens which are considered high-priority agents because they can be easily disseminated or transmitted from person to person, are characterized by high mortality rates, have the potential to cause major public health impact and require special attention in terms of preparedness.
Category B pathogens represent the second highest priority because they can be disseminated moderately easily, can cause moderate morbidity and require specific diagnostic capacity and enhanced disease surveillance.
Category C agents include emerging pathogens that can be engineered for mass dissemination because of their availability and ease of production. They have the potential for high morbidity and mortality rates. The guidance has been revised to align it with the current classification used by the US CDC.
EMA guidance on exposure to chemical agents
EMA guidance on treating and preventing exposure to biological agents
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