Futuristic approach to Regulatory Intelligence
Umesh Kurra, Manager – Global Regulatory Services, Freyr Solutions elaborates about the right approach to regulatory intelligence and explains how it will benefit in faster time to market while taking proactive regulatory decisions for global implementation, and improved operational excellence
Launching innovative products across global markets is an effective revenue generation method for life sciences companies. Regulatory compliance and approvals being the driving factors behind any successful launch, inadequate regulatory information can trigger an increase in costs and time-to-market. The role of a comprehensive regulatory intelligence (RI) approach is paramount in the launch process.
The life sciences industry is governed by continuously evolving regulations requiring industry players to stay informed and stay compliant. Keeping up with the ever-changing regulatory landscape can be challenging for life sciences manufacturers.
Furthermore, collation of the enormous amount of information, understanding and interpreting all the regulatory updates available on the Health Authority (HA) websites, third-party databases, and adapting to the new regulations puts an additional burden on the company resources. To counter these challenges and hurdles, an increasing number of organisations prefer to rely on RI tools and services. These tools and services assist in creating a compliant strategy and execution plan thereby avoiding any mishaps throughout the product lifecycle. For over a decade now, large and enterprise companies have been investing in a dedicated RI function. Despite the integration of RI tools, solutions, or support, organisations still face difficulties in decoding the regulations and complying with them. This could partly be due to the inefficiency of existing tools to tackle end-to-end RI on a global scale.
In this digital era, information is infinite. In fact, with so much information on hand, companies struggle to segregate useful information. Not all data is relevant to the companies and there can be a significant amount of noise that regulatory professionals need to filter. The information needs to be processed effectively for regulatory compliance and even the filtered-out information can also prove to be useful, with an effective approach for RI.
Moreover, as described in Table 1, different stakeholders responsible for regulatory compliance have different requirements. RI helps in meeting all these diverse needs.
So, what then constitutes the requirements for an ideal RI approach? An ideal 3600 RI support must encompass and support regulatory functions of Global Regulatory Affairs, Quality Assurance, CMC, Submissions, Labeling, Artwork and Packaging, Pharmacovigilance, Supply Chain, Technology and IT, Regulatory Policy, and Marketing.
From a bird’s eye view, the RI process seems effortless – gathering data, analysing information, and creating a regulatory strategy. RI is the key to unlock superior regulatory submission strategies and new market decisions. However, each step in this process includes a multitude of steps and brings with it its own set of challenges.
A comprehensive approach to RI
A wholesome approach for RI includes:
- Primary research that covers data sources across country updates, regulatory updates, congress coverage, trade associations coverage, authority and ministry coverage, key opinion leaders, and key influencers.
- Secondary research that encompasses data about country/product regulatory landscape, ongoing literature review, regulatory updates, clinical intelligence, HA updates, news and research, regulatory precedent of the policy, impact on the policy, lead countries and follow up countries.
- A technology solution that is a web-based, metadata-driven RI platform, real-time tracking and update, multiple information sources, actionable, auditable, collaborative social, and compare documents, regulations, and requirements globally.
- GRX Framework – IMPACT integrated with other technologies, in-house integration with DMS, PLM, submissions and other software, reusable content.
- Real-time distribution and action, real-time impact assessment of regulations and changes assign activities across departments for timely action
- Reporting and audit – Country/product specific comprehensive analysis, Newsletters and periodic reports, real-time news updates, on-demand reports, audit actions for compliance with changing regulations.
Another key aspect of regulatory compliance for organisations is being synchronous with regulatory policy and unmasking the gaps between regulatory policy and RI. Paving the way for the synchronous functioning of an organisation demands relentless efforts and support – both technological and functional.
As shown in Figure 1, every organisation should create an internal regulatory policy to comply with the HA policies and laws. Organisational policies need to govern internal procedures and processes. The RI data form the input for refining and enhancing existing policies.
Value proposition of RI
RI can be gathered, assessed, and used across various stages of the product life cycle. Its value proposition is immense in understanding the current trends and taking necessary actions for addressing both; functional and business needs of an organisation. As described in Table 2 and Figure 2, the value proposition of RI is multi-faceted and is significant throughout the product life cycle.
A regulatory strategy is an authorised approach that coordinates with regulatory affairs to launch an overhauled pharma product/ device into a market, backed with a brilliant marketing plan. A regulatory strategy defines the plan for developing a product