Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The worldwide challenge of antibiotic resistance. Strategies in Europe and USA from a regulatory point of view

Almut Koch (Abschlußjahr: 2016)

Summary
Language: English
The discovery of penicillin was a breakthrough in medicine and marked the start of the antibiotic era. From then on untreatable diseases and epidemics could be narrowed. Usually antibiotics are affordable and well tolerated drugs, broadly used in human and animals for acute infections and/or for prophylaxis. Modern medicinal achievements like surgery, organ transplantation or routine interventions are inconceivable without antibiotic drugs. As living organisms even bacteria underlie evolution and adapt to the challenges of their living environment: antibiotics and react with resistance mechanisms. WHO quotes AMR as serious threat to public health worldwide.
Emergence and spread of resistance is a multifactorial process and thus needs a multi-level reaction. Policymakers, Industry, Regulators, Healthcare Professionals and Stakeholders together must address AMR in a” holistic approach”. This master thesis has reviewed the possibilities to decrease AMR by regulatory action. With its engagement to improve regulatory processes for development and licensing by means of improved guidelines and enhanced scientific advice regulators contribute to facilitation and fostering of drug development especially for antibiotics. Via restricted authorisations and /or appropriate information on the medicinal products prudent and adequate use of antibiotics is promoted. Engagement and information exchange in collaborations contribute to a joint approach. But even if regulators and authorities perform a good work, the arms race against AMR must be attacked by joint efforts.
pages: 31 plus Annex pages: 9