Masterarbeit

Regulatory Challenges and Strategies for Allergen Products in the European Union and Canada ***

Dr. Mareike Schnaars (2019)

Summary
Language: English
The prevalence of allergic rhinitis and asthma is rising all over the world. Allergen immunotherapy is currently the only treatment with a direct effect on the cause and thus providing a long-term disease modifying effect. In addition, allergen immunotherapy is more cost-effective than pharmacotherapy. As a result it has the potential to reduce the treatment costs to patients and health care systems worldwide.
The Canadian market is a promising target for allergen products manufactured and authorized in the European Union. Therefore, this thesis is aimed at analyzing the regulatory framework for allergen products in both markets. The assessment is divided in three chapters, examining the legal basis as well as quality, nonclinical and clinical data requirements for allergen products of natural sources. Furthermore, Canadian and European requirements on product information and selected post-marketing activities are included in the assessment.
The analysis shows common regulatory requirements for allergen products in both Canada and the European Union. Region-specific deviations that have to be taken into account while seeking a marketing authorization are identified and discussed in detail. This thesis concludes with a summary of the most critical findings that might prolong the introduction of European products to the Canadian market together with a regulatory strategy to facilitate the scientific discourse with Health Canada.
Pages: 80
Annexes: 1 pages 1