Summary

Language: English

European and US initiatives promote the application of "risk based approaches" in drug regulatory affairs to meet todays patients needs. Risk based approaches have always been core elements of drug regulation and are frequently addressed in existing guidelines at the level of Quality, Safety and Efficacy. Importantly, it has the effect of focusing on critical aspects and not placing too much time on low-risk products.

Re-emphasising "risk based approaches" is also key to foster innovation and expand regulatory flexibility. It promotes a shift from "guideline thinking" to "public health thinking" aiming to meet the changing conditions of a globalised industry and provide early access to innovative products and technologies.

With the adoption of ICH Q8-9-10 the added value of scientific approaches and multidisciplinary perspectives has been emphasised. A link between ISO standards of risk management, pharmaceutical quality and patient safety has been generated. It can be applied optionally to different regulatory operations, development and manufacturing activities.

As any other tool "risk based approaches" have their limitations and may trigger new risks. Consequently, the performance of risk based approaches should be evaluated to decide on its effectiveness and to maintain target orientation.

The scope of this thesis is to describe to which extent the risk based approach is already implemented into the current legislation, to provide sources for definitions, to elaborate on the possibilities, opportunities and limitations given to apply this approach onto regulatory processes, and to discuss challenges to circumvent limitations of this approach from the industrial and authorities perspective of drug regulatory affairs.

Pages: 51