What Do You Think is Standing in the Way of Global Harmonization?

To fully understand what’s standing in the way of global harmonization, we need to first look at the tools and technology that regulatory professionals use to do their jobs. In order to keep up with increasingly stringent requirements, regulatory teams often stitch together a number of point solutions, which each only address a small part of the overall process. For example, they may use a document management system that’s only accessible by headquarters to author submission documents, a tool to review and approve those documents, a publishing tool to compile and publish these documents into a submission, a gateway to submit them to health authorities, and finally a variety of file shares and other insecure storage locations to archive completed submissions.

These tools are linked together through costly integrations, which become more expensive over time as companies must pay for initial development, testing, additional support staff, staggered upgrades, and long-term maintenance. In addition, working with a patchwork of integrated systems can impede visibility, create inefficiencies, and lead to a higher risk of non-compliance.

If we want to reach global harmonization, then regulatory professionals will need to standardize that technology and carve out clear roles and responsibilities within their organizations. One way to do that is by connecting team members through a unified RIM platform. Ideally, that platform will:

• Include native support for data and documents so regulatory teams can have all the information they need at their fingertips
• Be able to generate, submit, and store data exchange messages for seamless communication
• Support external systems through an open architecture for global participation

By introducing a single platform for regulatory information, teams can simplify their IT ecosystem, streamline end-to-end business processes, and increase productivity. For example, a unified RIM solution enabled a medium-sized biopharma to automate, and in some cases eliminate, 55% of the steps in their variation management process. They also gained access to real-time reports and dashboards, which dramatically improved visibility and control.

Once we reach a point where technology stops being a barrier to regulatory collaboration and starts being a facilitator then we will have a clearer path toward global harmonization.

To read more industry perspectives on global harmonization, check out the Informa Connect ebook “The Future of the Global Pharmaceutical Regulatory Affairs Industry”.