The life sciences industry is confronting a wave of transformational change, brought about by multiple factors, including the growth of new clinical trial markets, a rapid rise in drug development innovation, reimbursement challenges, heightened regulatory requirements and a demand for evidence-based medicine, among many others. These drivers and the resultant changes are having a profound effect on regulatory affairs.
Let’s begin with reimbursement and the pricing war that has ensued. The cost of bringing a new drug to market is well known, but increasingly governments, agencies, and patients are demanding justification for drug prices.
One method that agencies and insurers have been adopting is to advise companies they need to use evidence-based medicine to demonstrate their product provides exceptional value: for example that it is safer than products currently on the market, that it has better efficacy, or that it has been developed for rare or undertreated conditions.
At the same time, increased life expectancy, the rise in chronic and communicable diseases, patent expiries, and scientific and technology advances have led to hyper innovation and growth, creating a huge surge in submission volumes and licenses to maintain.
As a result, there is pressure to ensure alignment of regulatory affairs strategy, people, processes, data and technology with the rest of the organization to ensure data transparency and enable the company to be truly insights-driven. But in order to have data at their fingertips, regulatory affairs needs a technology solution that can access data across the product life cycle.
Another priority for industry is real-time compliance, with agencies asking regulatory affairs for metrics to be produced on demand at particular points in the life cycle. That proactive, real-time compliance requires continuous monitoring of quality metrics and resolution of associated compliance issues even before agency inspection.
Technologically speaking, it requires standardized drug regulatory software and consistent data models, as well as a commitment from regulatory affairs to take internal responsibility for proactive compliance tracking rather than simply seeing it as a data submission project. That means systems need to be connected and using the same terminology model, and that the latest analytical tools should be readily available.
All of these changes and more take place in an increasingly unstable political and legal environment, leading to shifting world trajectories and a need for a carefully balanced approach to development and the submission process.
As business pressures continue to mount on the organization, ensuring regulatory affairs is properly resourced – from an expertise and technology perspective – and able to work collaboratively with the rest of the organization will become all the more critical.
Join Pratyusha Pallavi, Product Manager – Regulatory, at the eRegulatory Summit, April 25-27 in Madrid, where she’ll be presenting on the topic of Regulatory 2020: Technology-Fueled Business Transformation, and where LifeSphere Regulatory will be also exhibiting.