A uniform regulatory approach supports the availability of effective and safe diagnostic devices and therapeutics in all European Member States and thus improves the treatment of allergy patients.
Many EU Member States have already begun to implement the recommendations on common regulatory approaches for allergen products (CMDh/399/2019) published in 2020 by the Heads of Medicines Agencies (HMA). The publication provides information on the applicable legal bases and requirements for the authorisation of different allergen products. The recommendations differentiate between therapeutic allergens and test allergens, between diagnostic devices for the detection of type I and type IV allergies, as well as between frequent and rare allergen sources. The directive and its implementation is a central milestone on the way to Europe-wide harmonisation of the authorisation and assessment of test and therapy allergens.
It has become clear in recent years that the current requirements in the context of authorisation procedures can impede the market access of allergen products for which only a small number of patients are available to participate in clinical studies. Therefore, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) asked the Rheumatology/Immunology Working Party (RIWP) to develop specific guidelines for development strategies for allergen products intended for use in allergies with only medium to small study populations. On the basis of a corresponding concept paper, the working group, led by the Paul-Ehrlich-Institut, is currently developing guidelines on general aspects regarding the development of allergen products for which only a limited number of patients are available. The guidelines will provide information on patient selection, evaluation of efficacy, study design, safety aspects, and quality considerations. A public consultation is expected to follow in Q1 2024.
The allergy experts at the Paul-Ehrlich-Institut play a significant role in the preparation of these guidelines and are committed to European harmonisation in the field of allergen products.
Prof Dr Vera Mahler (Head of the Allergology Division)
In the European Union, both test and therapy allergens are considered medicinal products according to the definition laid out in Directive 2001/83/EC. According to the directive, a medicinal product may not be placed on the market in a Member State until an authorisation has been granted. Authorisation requires proving that currently available information indicates that the medicinal product is of appropriate quality and is effective and safe. In Germany, the requirements of Directive 2001/83/EC have been fully implemented in the Medicinal Products Act (Arzneimittelgesetz, AMG).
There are exceptions to the above authorisation requirement: according to Article 5 of Directive 2001/83/EC, a Member State may, in cases of special need, exempt medicinal products intended for use in individual patients (personal formulations). Due to variations in the application of Article 5 of Directive 2001/83/EC in different Member States, the regulation of allergen products in Europe appears inhomogeneous. In some countries, the personal formulation exception is used so frequently that there are hardly any authorised products. This complicates mutual recognition procedures and the availability of allergen products. In light of these discrepancies, new guidelines are intended to harmonise the regulation of allergen products in Europe.