A large number of allergen extracts for diagnosis and/or treatment of allergies are available on the market. However, the safety and efficacy of many of them are controversial.
In 2004, the Food and Drug Administration (FDA) Center for Biologics Evaluations and Research (CBER), which regulates allergenic products, created a committee to review scientific data about the safety and efficacy of non-standardized allergen extracts. Such extracts were classified into five categories according to the level of scientific information to justify their use. For example, for pollen, Categories 1, 4, and 5 include 451, 250, and 7 species, respectively.
CBER proposed to remove all products classified in categories 4 and 5 due to safety concerns (Docket #FDA-2011-N-599). While this activity is taking place slowly due to the associated regulatory implications, the number of pollen extracts likely will be reduced to 451 species, all classified in Category 1. Allergen redundancy and/or cross-reactivity considerations should also indicate which pollen genera and/or species are clinically relevant.
Because of the increasing regulatory requirements regarding allergenic raw materials used in Europe, Lorentz et. al.,in 2009, proposed the concept of “homologous groups” to classify allergen sources. This concept is based on similar biochemical composition and homology/cross-reactivity of allergens or allergen sources. European regulatory agencies adopted this concept, and now require that allergen manufacturing companies obtain quality data for representative allergen sources classified in each homologous group, seven of which represent pollen species.
European regulatory agencies also have proposed norms to reduce the number of allergenic preparations available on the market. These approximations are analogous in concept to that proposed by CBER in the USA, but are generally more rigorous, and the number of allergen extracts permitted are fewer than those currently available in the USA.
France has stricter regulations regarding allergenic products, and therefore allergen manufacturers must also comply with the demands of the French medical authorities [Agence Française de Sécutité Sanitaire del Produits de Santé (AFSSAPS)]. The AFSSAPS groups aeroallergens in four classes, based on the scientific information currently available, but in an opposite ranking scale as adopted by CBER. Pollen classified in categories 1, 2, 3, and 4 include 24, 2, 7, and 10 species, respectively.
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