It is Time to Modernize Regulatory Affairs
By: Peter Lassoff, PharmD | February 03, 2015
When I first started working in regulatory affairs a few decades ago, nothing mattered but the science – or so we believed. If the submission was written on onion-skin paper with a fountain pen that was fine as long as the benefit-risk ratio was shown to be positive and every point of the proposed label was well defended.
We focused exclusively on the science and ensured that we had the right combination of expertise on the team to make the best decisions. It was a balancing act of ex-agency personnel and industry veterans who together could achieve ‘win-win’ negotiation with agencies, most of whom were in Europe, the US and Japan -- other regions were still considered ‘export’ markets at that time.
Over the years, this approach to regulatory affairs hasn’t changed too much. Science is still key to all decisions and reviews, and having the right combination of scientific and industry expertise on the team will always be vital to success. However, we can no longer afford to neglect the other key pillars that make our regulatory infrastructure function more efficiently – processes and technology.
Better, faster, cheaper
Traditionally as an industry we scope projects by estimating how long a person will take to complete a given task, but we rarely consider how we might optimize that process to improve outcomes. To do that, we must examine how we do things, break the down the work into small chunks, and analyze the optimum way to handle each task.
An important corollary of optimizing processes is that it gives us the opportunity to decide not just how a process is handled but where it is managed. Once we break down the processes into their component parts, some of tasks can be managed in cost-effective regions, thus ensuring the most economical result as well as the most efficient.
Similarly, technology has not been adequately deployed within the regulatory sphere. Over the years there have been many tech-focused step-wise improvements, from the first personal computers, to the days when everyone used Documentum, to today’s mandatory electronic submissions in many markets. However, large-scale tracking of submissions and approvals within the pharmaceutical industry is still largely spreadsheet-based, which prevents transparency and creates a lot of room for error. As a result, many companies struggle to know exactly which of their products are registered in which specific markets. In addition, corporate regulatory functions seldom know the exact contents of submissions in each country or region, let alone having a certified English translation of the submissions and approved labelling.
It is time to evolve this outdated system. The latest Regulatory Information Management (RIM) solutions and systems bring clarity and uniformity to the regulatory process, which eliminates risk and increases efficiencies across the global regulatory environment. These tools do more than automate paperwork. RIM systems provide regulatory planning and resource management tools, correspondence tracking, and custom dashboards that let companies monitor their progress and track relevant metrics. This gives pharma companies much greater insight into their regulatory program, enabling them to identify bottlenecks and mitigate risks before they create mistakes and costly delays.
Such technology platforms play a key role in the inevitable streamlining of the regulatory process. This isn’t just a nice-to-have option. In an industry as heavily regulatory as healthcare, it is vital that everything we do is tracked and that we have a common interface to ensure consistency and quality throughout our operations. A tech platform that runs throughout all we do provides the basic underpinning of our work. Most of the existing systems are cumbersome and non-intuitive, but the latest software can be picked up quickly by staff in Local Operating Companies as well as regulatory headquarters.
Technology and process optimization aligned with existing outstanding people resources form the backbone of a strong and prosperous regulatory team. It makes for an excellent resolution as we set goals for the New Year.