Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory burden, adequate to Allergen Specific Immunotherapy? ***

Christian Döring (Abschlußjahr: 2014)

Summary
Language: English
Allergies belong to the wide spread disease with an incidence of about 20 %. Worldwide more than 500 million people suffer from those overshooting reactions of the immune system. The only way for a causal treatment against Type I allergies caused by aero allergens is an allergen specific immunotherapy (AIT) which re-educates the immune system and which inures it to the allergens of the environment.
Over the last few years, especially the German regulatory framework for AIT has undergone multiple changes. The therapy allergen ordinance (TAV), the institutional batch release criteria and the implementation of the updated European Pharmacopeia are challenging the AIT manufacturers. In addition, other health care specific developments show a big impact on the German AIT as well. The increase of the mandatory rebate, the consequences of the pharma package of 2012, and the implementation of the updated GDP guideline requirements lead to an overwhelming catalog of new challenges in AIT.
Considering all these duties and responsibilities and comparing the regulatory situation against the financial side of the business, this leads to the question whether the regulatory burden on AIT is still adequate. Of course, in conclusion most regulatory requirements are useful and eligible to raise the levels of CMC development, product safety and clinical. But the missing attempt to harmonize AIT within the EU on a regulatory level and the shrinking diagnostic width in Germany are a cause of concern. In addition, it needs to be questioned whether the general regulatory burden is too much in conflict with the financial situation of the German AIT companies. Until today, it is not totally clear if the national AIT industry can afford to fulfill their regulatory related development duties within a decreasing market.
Pages: 63
Annex pages: 1