In early August 2011 the European Medicines Agency (EMA) released a draft document entitled “Reflection Paper on Risk Based Quality Management in Clinical Trials.”1 Later the same month the US Food and Drug Administration (FDA) released a draft Guidance for Industry entitled “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.”2 As for other draft guidances issued by both agencies, there followed a period of public consultation during which individuals and companies could submit comments and suggestions to shape the agency’s preparation of the final versions of the guidelines. The final guidances will be issued in due course.

This paper will focus on the draft document from the FDA and offers conjectures on the implications of the new regulatory landscape it engenders, assuming (as seems reasonable to presume at this time) that the final document remains similar in spirit to those of the current drafts. Moreover, it is also appropriate to review the EMA reflection paper, since the language and spirit of the two documents is strikingly similar.