Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Quality of Allergen Products for Specific Immunotherapy - A Guidance for Industry for Compilation of Module 3 for the EU CTD (Quality) Considering the German Therapy - Allergen Ordinance, the revised European Pharmacopoeia Monograph on Allergen Products (2010:1063) and the new "Guideline on Allergen Products - Production and Quality Issues" (EMEA/CHMP/BWP/304821/2007) ***

Dr. Anna Silke Limpert (Abschlußjahr: 2010)

Language: English

The regulatory environment for allergen products in Germany has undergone significant changes in recent years. Novel regulatory requirements were introduced with the Therapy Allergen Ordinance, issued in 2008, that put especially named patient products under a more stringent control by the Paul-Ehrlich-Institut (PEI). Furthermore, the quality standards and requirements for allergen products were raised with the revised Guideline for Allergen Products: Production and Quality Issues (EMEA/CHMP/BWP/304831/2007) and a revised monograph on allergen products (2010:1063, Producta Allergenica) of the European Pharmacopoeia. In response to these changes, manufacturers have to meet the challenge of establishing marketing authorization application dossiers for allergen products that were marketed as Named Patient products without marketing authorization. What is more, available guidance on the compilation of dossiers for these products is very limited.

In its first part, this thesis provides a brief introduction to allergy and asthma, products for specific immunotherapy for subcutaneous use and introduces the concept of Named Patient Products in contrast to allergen products with a regular Marketing Authorization (Chapters 1 and 2). The third part provides a summary of the current regulatory environment and its scientific basis for allergen products derived from natural source materials and intended for subcutaneous specific immunotherapy (chapter 3). Furthermore, a quick reference guide for the compilation of Module 3 of the EU CTD is provided in chapter 4. Using ICH M4Q (R1) as basis, the novel regulatory requirements for allergen products are integrated into the CTD structure. The last part of this thesis provides a brief evaluation of the impact the German Therapy Allergen Ordinance has on the German market for allergen products and ventures an outlook on similar regulations being drafted in Europe (Chapters 5 and 6).

Pages: 57, Annexes: 1 pages: 1