Introduction to Regulatory Intelligence

Regulatory intelligence is a systematic process of collecting, analyzing, and disseminating information about regulatory requirements, policies, and guidelines that affect the development, manufacturing, distribution, and surveillance and regulation of medical devices.

Regulatory Intelligence helps your organization anticipate and manage global regulatory developments in a single solution, removing the burden of having to manually track multiple sources of regulatory information.

Regulatory intelligence has gained significant importance with increasingly global considerations for product development, clinical trials, and submissions to ensure market access in key regions. The regulatory intelligence profession, tasked with providing strategic input to ensure regulatory compliance, has evolved to fulfill the additional needs of various departments within the company and by senior leadership by strategically analyzing relevant regulations and product competitive landscapes. The increased complexity of products and implementation of technological innovations is again changing the demands on the regulatory intelligence professional. 

The goal of regulatory intelligence at manufacturers is to provide executives with the latest information on an ongoing basis. They need this to make informed decisions in the following areas:

• Deciding on medical devices to develop
• Determine which markets to bring products to and in what order
• Determine the current and future regulatory requirements in these markets
• Decide whether to participate in or object to planned regulations
• Estimate efforts, durations, and costs to meet regulatory requirements
• Ensure that the necessary staff with the required skills and competencies are in place
• Plan and organize additional resources (service providers, tools, financial resources)

Key Components of Regulatory Intelligence

Sources and communication: Regulatory intelligence sources differ across companies. Larger, better resourced companies can purchase licenses to paid subscription services, whereas smaller companies have to rely on public sources of regulatory intelligence. The survey respondents indicated that the most popular source of regulatory intelligence was regulatory authority websites, which is understandable because they are the best source of regulatory information. It is interesting to note that the 2019 survey results indicated less usage of subscription services compared with findings in the previous iterations of the survey. That might point to there being more free information available on the internet, which reduces the need to pay for quality regulatory intelligence.
 
Respondents were also asked about their use of social media as regulatory intelligence resources, and the most common source mentioned was professional association discussion forums, such as the RAPS RegEx platform. Surprisingly, the least-used resource was Twitter. Twitter can be difficult to use as its functionality and user interface differs from more commonly used social media sites. However, Twitter is a remarkably useful tool for competitive analysis. Frequent Twitter users can be exceptional at dissecting company press releases and highlighting key takeaways.

Information Sources for Regulatory Intelligence

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:

1. Internal Sources

Precedence: Leveraging past regulatory strategies, timelines for approvals, and internal interactions with local affiliates help in planning and defining filing strategies and optimal approval pathways that can lead to successful First-Time Right submissions

Insights from prior HA Interactions/Advisory Meetings/Queries: This is an invaluable source of information for companies as they steer through many such HA interactions across the globe for various products across therapeutic areas. A repository with the ability to pull out the needed information ensures efficient planning in line with RA expectations, and consistent responses for the product while also serving as a basis for subsequent reference and future planning.

Regional Regulatory Affiliates: Another credible source of tribal regulatory information comes from regional and/or local regulatory affiliates and Regulatory Affairs Managers, who are the primary recipients of regulatory information from local HAs, where information is mostly available in the local languages, especially in the Asia Pacific or Latin America regions.

2. External Sources

Health Authority Websites: HA websites can provide critical information for defining the overall regulatory strategy for the product, its development, marketing approval/authorization, and further life cycle management. These websites provide access to the most recent guidance documents, policies, regulations, and drug approval summaries/assessment reports.

Competitive intelligence: Company website press releases, annual reports from competitors, newsletters, and competitor labels are other sources of intelligence providing insights on the unmet areas and opportunities, safety issues, recalls, and competitive positioning of products. In addition, public access to clinical trial registries, EPARs – European public assessment reports, and evaluation reports available via health agency websites provides a warehouse of competitive intelligence.

News Releases: Press releases, news updates, bulletins, and newsletters on initiatives, directives, guidance documents, regulations, warning letters, decrees, and published in the public domain.

Industry Events: Industry events including conferences, seminars, and workshops the regulatory landscape, organized by healthcare companies.

Regulatory Platforms: Network of regulatory professionals through various platforms and paid subscriptions.

Published Papers: Insights from published white papers, literatures, podcasts, blogs, webinars, presentations, etc.

Clinical Trial Registries: Country-level intelligence on clinical trials and their endpoints can be availed from registries such as the World Health Organization (WHO) – International Clinical Trials Registry Platform (ICTR), EU-CTR, US National Institutes of Health, Japan Primary Registries Network (JPRN), Clinical Trials Registry – India (CTRI), German Clinical Trials Register (DRKS), and so on.

Criticality of Regulatory Intelligence

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:

Product Development: Assessing new business requirements for due diligence, target product profile, potential risks, impact on supply chain, competitive analysis, and tracking progress are critical starting from discovery to approval of the product and post-approval compliance and life cycle management.

Global Filing Strategy: Regulatory strategy is integral to any new product submission, product, geographic expansion, or life cycle management. Each strategy must consider information that includes external data sources (HA websites, policies, regulations, publications, etc.) and internal data sources (precedence information/lessons learned).The filing strategy should incorporate key milestones and decision points; regulatory objectives, obstacles, and regulatory landscape, and characterize risks to potential success in delivering a specific regulatory outcome. A global regulatory strategist must consult with the regional regulatory affiliates to provide regional regulatory requirements and experience, and cross-functional experts such as CMC, nonclinical, and clinical, to enable the contribution of relevant documents for submissions.

Risk Mitigation: RI can be applied for early identification of risks to effectively plan mitigation strategies for further development at product launch and during post-approval based on current requirements and precedents.

Preparation for Regulatory Meetings and Briefings: Prior knowledge and a clear interpretation of the regulatory requirements help develop a precise, well-organized briefing document presenting a clear company position with a targeted set of questions that goes a long way in eliciting detailed responses/discussion with the HA.

HA Query Management: A repository of experience from past HA queries allows the user to predict possible HA queries based on submission type/therapeutic area/similar markets and propose the best suitable resolutions. Further, a consistent approach to common queries can be standardized.

Shaping Future Policies and Regulations: A continuous monitoring of the regulatory landscape as well as interpreting and evaluating the implications create opportunities for pharma organizations to collaborate with health agencies in shaping the future regulations, guidance, policy, and legislations

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:

Source Identification: As each market is different, it is essential to identify the right sources to gather relevant information. Additionally, not all sources provide comprehensive information for all areas. For instance, HAs of the United States, Europe, and Japan promote transparency, and the most recent updates would likely be accessible. At the same time, there could be inadequate or non-credible information available in developing markets for specific countries across the Asia Pacific or Latin America. Knowing these differences can ensure an effective process to collect regulatory information from public websites supplemented with information received from local regulatory professionals who engage with the local health authorities.

Extensive Research: The use of keywords applied through search strings is significant for setting alerts or mining relevant and latest data.

Data Curation: Upon collating relevant information, structuring and grouping the data help in screening, removing redundant information while retaining only the newest and most appropriate content in the context of the requirement.

Analysis: The compiled regulatory information is further analyzed to highlight regulatory rules and obligations and identify trends and patterns.

Impact Assessment: Once regulatory intelligence data are analyzed, the impact of new or updated regulations on a particular market is assessed, and an impact assessment grade (high, medium, or low) may be assigned based on the market or product of interest.

Intelligence Report Generation: A well-organized RI report can be established to meet business requirements and preparedness for regulatory changes across geographies. Such reports contain the latest update and their impact around the targeted products, therapy areas, product lines, geographies, and so on. This helps the regulatory professionals to frame an appropriate regulatory strategy as per the company’s requirements.

The Role of Technology in Regulatory Intelligence

Emerging technologies and systems for monitoring regulatory requirements need to be implemented to address the challenges created by the rapid regulatory developments. The scale and complexity of those developments have outpaced the ability of in-house teams of regulatory affairs professionals, which are typically small, to effectively manage compliance. Next generation regulatory intelligence systems and technologically advanced solutions have become an immediate need.
 
Artificial intelligence (AI), a maturing technology, is increasingly explored for its application  to regulatory compliance and intelligence monitoring. The implementation of AI into state-of-the-art regulatory intelligence monitoring presents unique opportunities for surveillance, for example, of new regulatory information and formal and proposed regulations. This AI-enabled surveillance provides strategic advantages, allowing the regulatory professional to develop proactive strategy and make more efficient proactive compliance modifications, thereby reducing the burden of reactive compliance adjustments.
 
In the current environment, regulatory intelligence is generally the monitoring, gathering, and analyzing of publicly available and experience-based regulatory information needed to develop a strategy for time- and cost-saving drug development. Regulatory intelligence is not just information and knowledge management. There is a need to put the “intelligence” into the collected regulatory information by conducting an impact analysis and efficiently disseminating findings to build strategies. Regulatory intelligence adds value to the information and can also help shape the environment to create a competitive advantage.

Information overload, caused by the evolution of information technology, is a common phenomenon experienced by regulatory intelligence professionals – there is just too much information becoming available at an ever-increasing speed. The increasing volume of information released by health authorities, databases, social media, internet resources; and the necessity to develop globalized strategies addressing increasing numbers of jurisdictions contribute to the pressure on regulatory intelligence professionals to work through this information effectively. Regulatory intelligence professionals serve as filters for this information overflow, capturing and analyzing the pertinent information based on business priorities. Regulatory intelligence professionals can support business success in many ways, for example, by developing robust strategies through regulatory landscape knowledge (including precedent and surveillance), aligning understanding of regulatory requirements through education, reducing the risk of noncompliance, and analyzing the impact of regulatory requirement changes to ensure continued compliance. In addition, regulatory intelligence professionals are in a unique position to influence the external environment, including regulatory agencies and policy makers through interaction, advocacy, and providing comments in response to new guidance and/or policy documents issued by regulatory agencies.

Over the past decade, the availability of regulatory information has significantly increased, and online search engines have become more efficient. Simultaneously, availability of large amounts information creates the challenge to analyze and meaningfully arrange this information for effective dissemination. Most regulatory professionals do not have sufficient time and/or technology resources.  Rapid and streamlined approaches to collating regulatory and legislative data through emerging technology, such as AI, will be needed to support regulatory intelligence professionals. Adaption to and implementation of new tools is inevitable amid the challenges in regulatory strategy and compliance. Development of AI applications and tools in regulatory intelligence is an evolving field. It is envisaged to support life sciences companies in efficiently managing modern world complexities of business overall and the regulatory environment in particular.  The regulatory intelligence profession of tomorrow will continue to shift into data analytics and informatics for surveillance of the regulatory landscape. However, interpretation of insights and developing effective strategies will remain a key function of regulatory intelligence and continue to require human analysis and skills.

Although the increase in availability of information is generally embraced, it also creates challenges around timely uptake and appropriate dissemination of information. Generally, industry has reacted by assigning increased numbers of regulatory intelligence professionals full or part time to monitor and inform regulatory strategies. With the increase in information availability and growing complexity, the need for using developing technology – particularly artificial intelligence, natural language processing, and machine learning – becomes more prevalent. Despite this increased need, the regulatory intelligence function currently remains small, independent of company size, which underpins the need for implementation of evolving technology to support the regulatory intelligence team.