The regulatory information on the advancements in healthcare and technology, insights on the approaches to support patients with unmet needs, and policy influences on the drug development processes keep on evolving constantly. Staying abreast of the continuous thread of this information requires careful consideration to the credence and the impact this information has for all pharmaceutical companies globally. Although this information is complex to organize and manage, it is critical in achieving successful product (drug/device) registrations and market authorization. The health authority (HA) guidelines, policies, and laws governing the product registration, manufacturing, or licensing processes vary across markets, based on that country’s healthcare requirements. Leveraging precedence, insights, and continuous monitoring of the regulatory environment can benefit regulatory professionals to strategically plan and expedite the product approval processes as well as address HA queries. Establishing an effective regulatory intelligence (RI) data strategy, governance, and review procedures from early development through the launch of the products provides the best opportunity to increase confidence in the submission compliance for each product class and HA. Therefore, the RI lifecycle management practice is the backbone of any pharma submission strategy and submission plans.
Traditionally, RI lifecycle management has been implemented either by proactively acquiring a broad set of defined regulatory information from various sources, assessing their impacts, and generating contextual insights; or by tactically procuring information for a novel cause or requirement when required1. Each approach has its merits and efficiency opportunities. When implementing either of these approaches, it is crucial for the RI governance to consider the needs of a broad set of roles across business functions including regulatory affairs, pharmacovigilance, clinical development (such as R&D, chemistry, manufacturing, and controls [CMC], clinical, nonclinical) and regulatory writers, so that information presented can enable these functions to work collectively through the product development lifecycle and strategically plan for HA briefings at each milestone and eventual submission.
Timelines to perform the product risk analysis could be accurately determined only if the regulatory submission strategist acquires all the necessary regulatory updates for that particular market in a timely manner through constant monitoring of the landscape and utilizing precedence where applicable to develop a strategy. For instance, over the past couple of years, amid the coronavirus disease 2019 (COVID-19) pandemic, several regulatory authorities have amended or updated their regulations with flexibility for accelerated pathways to approvals, more so concerning emergency use. There have also been many guidelines around clinical trials’ conduct given the pandemic’s impact on the various aspects of trial conduct, including trial participants, healthcare providers, infrastructure, and logistics. Proactive investment on expert regulatory guidance and strategies could help achieve timely and accurate regulatory filings for approvals, and reduce delays, noncompliance, or penalties.
Curating relevant regulatory information from various authentic sources is an important step and crucial to generating an efficient RI report. However, no single source provides collated information across markets; therefore, urging regulatory professionals to perform robust research for identifying appropriate sources to gather relevant regulatory information either for an immediate requirement or routine monitoring. Broadly, the sources could be classified based on their origin as below:
Regulatory Intelligence plays a critical role in regulatory strategy and operations, product due diligence, target product identification, clinical development, feasibility assessment for global/local clinical trials, manufacturing requirements, regulatory submissions, and further modifications that may be planned post-approval. The key uses of RI include:
Regulatory intelligence activities require data mining, aggregation, analysis, and validation to generate intelligence reports in a desired format, thereby reducing resource burden and ensuring compliance to regulatory standards and requirements. Some of the key steps involved in the RI process include:
A well-formulated report must present appropriate information in an easy readable format. The RI report may be generated in an agreed template to meet the requirements. Some of the ways to disseminate RI include:
The COVID-19 pandemic has impacted product development and availability, including delays in clinical trials, the schedule of onsite inspections, workshops, submissions, subsequent approvals, and so on. Many HAs have proactively engaged with patient groups, therapeutic area/disease experts, and leading scientific bodies/experts toward minimizing the impact on trial subjects, patients, and healthcare in general, providing constant updates on the regulations and guidelines. On the other hand, the development of products, including biologics and vaccines, has been fast-tracked, ensuring the availability of the treatment or therapies for patients with Covid-19 worldwide. Health authorities across the globe have identified approaches to expedite product availability (fast-track reviews/approvals, rolling submissions, Emergency Use Authorization, to name a few). FDA’s “Fast Track” designation program allows for the opportunity of a “rolling review” of New Drug Applications and Biologics License Applications that can be requested early in the product development process at the time of Investigational New Drug (IND) filing or after completion of Phase I studies. There is a strong emphasis on the importance of continuous communication with the FDA so that questions can be resolved quickly for fast-track submissions.
Therefore, understanding the regulatory HA, continuous tracking, consulting with appropriate forums, workshops, and surveillance are essential in ensuring that the most current information is made available to stay abreast with the current information.
Some of the potential challenges in tracking, reconciliation, and reviewing RI are listed below.
Several pharmaceutical companies are leveraging artificial intelligence (AI) technology for data processing and improved healthcare outcomes. Over the recent years, AI applications have been developed in the field of RI for strategic data wrangling by applying Natural Language Processing models to aggregate insights from public data sources, evaluate confidence in knowledge gathered to determine the risk for a submission, apply predictive analytics to determine the optimal filing strategy, gather and leverage precedence intelligence, translations (local language to English), timely monitoring of roles activities, and creating alerts. These initiatives have optimized a pharma company’s capabilities, improved efficiency, and decreased human intervention. An AI-enabled RI system can ensure current information through a single repository for relevant information and real-time updates on changing regulations.
According to a survey by Mayer et al.3, 22 pharmaceutical companies and 3 companies leading in RI and AI technologies were interviewed for their value proposition, barriers, and risks. The companies considered that AI offered significant opportunities for RI activities on data processing involving mining, searching, monitoring, and alerting. The study results also showed that 32% of companies envisage the use of AI in data synthesis (combining different types of information across formats), 36% in data analysis (trends, predictive analysis), and 23% in decision-making. Overall, the assessment revealed a paucity of fully developed AI tools, although the demand from the RI community is gaining recognition. Studies on the application of AI technology in RI landscape claim that now is the time to advance the technology more than ever. There are various opportunities to enhance the quality, speed, and efficiency of RI activities3. Indeed, the significant contribution of AI toward the RI activities delivers greater agility in terms of saving time and costs.
The dynamic and advancing approaches for RI lifecycle management have been critical in accelerating the pharmaceutical product development and approval. The development of strategic data sourcing, aggregation, and application of regulatory intelligence can be the key to success for any drug or device development.
With their respective expertise and knowledge, Regulatory and technology professionals play a pivotal role in the success of the entire process. An efficient RI team enables seamless strategic planning and execution toward achieving the overall goal of making safe and efficacious medicines available, in a timely and regulated manner to patients across the globe.