German and Austrian drug agencies intensify cooperation on regulation of allergen products
A team from the Austrian Federal Office for Safety in Health Care (BASG) was a guest at the Paul Ehrlich Institute (PEI) on Jan. 14, 2019. The aim was to cooperate more closely in the future in the regulation of medicinal products for the diagnosis and immunotherapy of allergies.
Prof. Stefan Vieths, Vice President of the PEI, and Prof. Vera Mahler, Head of the Department of Allergology at the PEI, presented the PEI's experience in implementing the Therapy Allergen Regulation (TAV). The experts discussed the current regulatory situation of allergen products in Germany and Austria and exchanged views on future challenges.
DI Dr. Christa Wirthumer-Hoche, procedural member of the BASG and head of the Austrian Medical Market Surveillance emphasized the importance of the intended European harmonization for the regulation of allergen products and its impact on the work of PEI and BASG. The participants agreed on further intensive cooperation in order to jointly contribute to an optimal supply of patients with high-quality test and therapy allergens.