Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Impact of the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00) on the Pharmaceutical Development

Yuwei Heinzel (Abschlußjahr: 2007)

Language: English

The present thesis:

• Explains the background of the Guideline on the Environmental Risk Assessment (ERA-Guideline) of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00, effected on 01.12.2006) and its development, which gives a complete understanding of the outcome on the basis of scientific, strategic and political handling regarding protection of the environment in the area of pharmaceutical development.
• Summarizes an overview of the ERA-Guideline with focus on the assessment strategy, which explains the filter principles and measures for detection of the potential environmental effects of medicinal products.
• Discusses the regulatory impact (known and assumed) of the ERA-Guideline on the pharmaceutical development and on the regulatory practice with examples of ERA
• Concludes that the ERA-Guideline for human use represents a positive step towards the improvement of our understanding of the potential environmental impact of medicinal products and allows the possibility to gather more scientific experience and give a direction for the pharmaceutical development.

Pages: 44