On 13 June 2017, 18 ESCD members from 11 European countries met at the VU Amsterdam, very nicely hosted by Thomas Rustemeyer, for a constituting meeting of a new working party. This working party had been suggested and confirmed at the Manchester general assembly in September 2016; subsequently, a call for participation and the first meeting had been organised by the ESCD secretary, David Orton. In the apporox. 2 h of the initial meeting, a brainstorming of different conceptual aspects, but also of actual haptens to be included to, modified, or omitted from, the present European Baseline Series (EBS) were discussed. As an important organisational milestone, Mark Wilkinson, Leeds, UK (email@example.com) was elected as working party convener and as vice convener Margarida Gonçalo, Coimbra, Portugal (firstname.lastname@example.org).
Preparatory work before the next meeting (11am on 28 November 2017, again at VU Amsterdam) will include refining criteria for inclusion in the EBS, suggesting modifications, also including a more experimental add-on series to the EBS, tested along with it in consecutive patients. The aim is to provide a definite change list for comments by the ESCD membership and ratification at the Milan meeting, 18 to 20 October 2018.
Wolfgang Uter, 4 July 2017
By Prof. V Mahler
In the EU, allergen products are defined as medicinal products according to Directive 2001/83/EC. This definition includes allergen products for the in vivo diagnosis of type IV hypersensitivities. However, despite the common legal framework set out by this directive, there is a considerable heterogeneity in the approach on how EU member states are actually regulating allergen products. The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) was informed that the increased obligations related to the Pharmacovigilance legislation as well as GMP requirements, combined with limited reimbursement options in some EU Member States have led to a decreasing number of authorised allergens.
It was noted that different regulatory decisions are taken by Member States to allow allergen products on the market (marketed as named patient products vs. marketing authorisation per individual allergen or containing diverse active substances under one combined marketing authorisation). As a result of the regulatory disharmony observed in the EU and related problems thereof, the CMDh has created a drafting group that is now working on the development of proposals for harmonized regulatory approaches for allergen products within the EU.
Due to the complexity of the issues discussed in this group, it is expected that the activities will require some time to result in potential changes in the regulatory framework of allergen products. Current updates on the progress of the drafting group with respect to specific milestones will be referenced in the CMDh Meeting minutes which are publicly available at the CMDh website (http://www.hma.eu/457.html).
Furthermore, the CMDh has requested the Committee for Medicinal Products for Human Use (CHMP) to discuss the scientific requirements on allergens with lower prevalence. The CHMP agreed for a drafting group to work on a concept paper Minutes of the meeting from December 2016,
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