Therapy Allergen Regulation (TAV) is making progress: Association talk between PEI and BPI

Marketing authorisation procedures of therapy allergens pursuant to the Therapy Allergen Ordinance (Therapieallergene-Verordnung, TAV) are on a good road – two therapy allergens have already been authorised by the Paul-Ehrlich-Institut (PEI). The dialogue between the Federal Association of the Pharmaceutical Industry (Bundesverband der Pharmazeutischen Industrie (BPI)) is indispensable for implementing this long-term and fundamental development process. "The exchange optimises the interfaces in the development, marketing authorisation, and testing," said Professor Stefan Vieths, vice president of the PEI. Thus, more and more high-quality, efficacious, and safe therapy allergens for the treatment of common allergies will be available to patients soon. A particular focus is on children – therapy allergens also have to be tested for this patient group.

Participants of PEI and BPI dialogue meeting Source: B. Morgenroth / PEI

One item on the agenda is the implementation of the therapy allergen ordinance (TAV), which requires therapy allergens against common sources of allergens to have a marketing authorisation. The marketing authorisation procedures pursuant to the TAV are currently still ongoing for 65 therapy allergens. Following the lists of questions on clinical issues sent by the PEI in 2018, the companies now have the opportunity to complete clinical development within the defined transition periods. For this purpose, the companies are obliged to perform clinical trials also in children in a timely manner. State of the art clinical data on efficacy and safety in children are still lacking for the majority of TAV products. Without such data a marketing authorisation for the treatment of children is not possible.

The BPI representatives have confirmed a major requirement for scientific advice, which the PEI provides for all phases of the development programme.