Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Drug Risk Management from an Industry Perspective - a Task for the Life Time of a Medicinal Product ***

Dr. Hans-Joachim Gamperl (Abschlußjahr: 2006)

The key role of pharmaceutical industry in society is determined by its contribution to public health and individual patients welfare in providing safe and efficient medicinal products. This contribution is mainly a function of the economic success of these private enterprises in regards to investments in medicinal product development. Pharmaceuticals are still a prospering market especially in new therapeutic areas like medicinal products deriving from biotechnological processes. Society generally expects rapid approval by competent authorities of innovative life saving or standard of life maintaining medicinal products that are both, efficient and safe. However, competent authorities determination of a safe product does not suggest the absence of risk. As the data from clinical trials are still limited in terms of the safety of the medicinal product at the time of approval, the significant increase of exposure when marketed may reveal new risks. The experience of the last decades show that globally more than 130 medicinal products had to be withdrawn from the market due to safety reasons. The major part of the products were banned from the market during early marketing period, a target period for risk management. As safety data are arising continuously during development and marketing, regulators have considerably shifted strategies in risk management from traditional post-marketing pharmacovigilance activities to earlier and more detailed investigation of safety issues during development. Traditional systems were not optimally designed to assure that adverse drug reactions for new drugs are identified early in order to limit exposure of public to potential risks of the medicinal product. New strategies in drug risk management have been developed by international organisations like ICH and CIOMS and their usage recommended or even officially requested by regulators. All initiatives have in common to build a solid safety database considering also data from early development like pre-clinical data, etc. ICH, EU and FDA initiatives focus on late stage development and post-marketing periods. CIOMS is putting the emphasis on starting drug risk management already in early clinical development. While ICH and EU are elaborating especially on pharmacovigilance planning, FDA RiskMAP guidance presents detailed tools how to minimize drug risks and how to evaluate the efficiency of these tools. Drug development and approval for marketing is a global challenge and for the practical implementation of drug risk management systems into the pharmacovigilance processes of a pharmaceutical company all initiatives together may be seen as collection of recommendations and examples where the sponsor, applicant or MAH could arrange the appropriate package for his particular product and strategy:

• CIOMS VI DRMP may be seen as the initial activity, the early start in collecting available safety data and then adding additional data as they arise in the course of clinical development
• FDA Pre-Marketing Guidance could give valuable support in the appropriate composition of the safety database
• ICH E2E Guideline and FDA Pharmacovigilance Guidance advise in the efficient selection and use of pharmacoepidemiological tools for pharmaco-vigilance planning
• FDA RiskMAP Guidance and EU Guideline on Risk Management Systems give advise in regards to risk minimization activities and their evaluation.

Pages: 57