It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now. As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and to harmonize standards within the industry. While we can immediately understand the benefits of reducing duplicative inspections and the efficiencies gained by these regulatory bodies, we often overlook the similar benefit to the companies in our industry themselves. Fewer inspections at firms’ sites will reduce the burden on companies and thus allow them to focus on making quality products for consumers. By maintaining robust and compliant quality systems worthy of scrutiny by any of the regulators, companies further reduce the frequency of inspections. Are you considering this, as you search for your true Cost of Compliance?
The following links provide insight into the EMA’s global MRA efforts and FDA’s efforts to date in helping regulatory bodies reach an efficient method of sharing results and harmonizing our standards.
If your firm needs any assistance interpreting the impact that international cooperative agreements will have on your multi-national operations, we can help! Please contact David Lonza at D.Lonza@LachmanConsultants.com.