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Regulatory Intelligence — a corner stone in Regulatory Affairs

When working in Regulatory Affairs (RA), you must continuously be on your toes! In an ever-changing regulatory landscape, numerous regulatory recommendations/directives/guidelines, continuous amendments/updates and the various sources required to locate them might appear overwhelming and complicated. You may ask yourself; how should you proceed when a new regulatory trend is observed, or when agencies send out guidelines for review or publish a finalised enforcing version? How should a life science company prepare for upcoming changes, and how do you ensure timely review of guidelines? How can the impact of the changes be assessed? How can you determine which stakeholders to involve and in what way? How do you ensure a slim and transparent, yet efficient process, from start to end? The answer to all these questions is simple; by utilising Regulatory Intelligence (RI).

Regulatory Intelligence staff — not just “hunting dogs”

Adopting systems and resources to handle and optimize RI is essential for Regulatory Affairs organisations in pharma companies who work on obtaining and maintaining medicinal drug and device licenses across the globe. A well-functioning RI function can facilitate right first-time submissions to agencies, thus ensuring faster approvals. Furthermore, it can be leveraged to maneuvering into new therapeutic areas, as well as enabling organisations to steer clear of costly and time-consuming mistakes.

As a minimum, RI staff in a pharmaceutical company operate as “hunting dogs”, bringing back “prey” (e.g. requirements and regulatory trends) to the rest of the RA department, who will then perform impact assessments and implement necessary changes. Nevertheless, the RI personnel’s responsibilities could easily be expanded to analysing and digesting the so-called prey, thus managing subsequent internal processes for assessing and implementing change. If the RA organisation is big and resourceful, the RI function can become an anchor between trend detection and implementation of change, wherewith it can become an active element of drafting policies and framing executive strategies.

The setup and amount of resources allocated to RI vary between pharma companies. In large global pharma companies, RI functions are often well-defined with several full-time employees constituting the department. Contrarily, in affiliate offices or small pharma companies, regulatory professionals will usually be assigned RI-related tasks in addition to their regular tasks. Therefore, the “Regulatory organisation” might be limited to just one person responsible for the full range of RA activities related to obtaining and maintaining medicinal drug and device licenses.

Having engaged RI staff in the field (pro)actively hunting for RI is crucial to maintain compliance and stay on the market within pharma. Being “in the field” should be considered as being at the right place at the right time. Often this excludes sitting at a desk behind a computer screen all day, as time should be spent on getting out “in the real world” and establish strong networks with decision-makers. By becoming a trustworthy member of industry associations and regulatory networks, attending global and local events/summits/conferences, as well as attending collaboration and informative meetings with agencies whenever possible, the RI staff will start to become valuable assets. Inevitably, such engagement will result in RI staff being able to “sniff” what is upcoming within the regulatory landscape as early as possible, enabling a company to prepare for the change well in advance.

Figure 1. Obtaining and handling Regulatory Intelligence in Regulatory Affairs

Recent changes within regulatory are Serialization, Track & Trace, xEVMPD (to be converted into IDMP) and the new Medical Device Regulation (MDR) to be enforced May 2021. These changes emerged as ideas within various agencies globally but are now converted into regulations and addressed by many Health Authorities (HAs) across the world.

Such impactful regulatory updates have led to an expensive and time-consuming reformation of multiple functions in pharma companies, hereunder production environment, Supply Chain, Regulatory Information Management (RIM), IT systems, and submission readiness. If a company lacks competent experts, resources and an effective system and processes to discover these trends before they are published and enforced, it can lead to a significant detriment of essential business functions, thus potentially resulting in non-compliance and decreasing market shares.

A significant advantage of having alert and proactive staff hunting RI is that a company get the possibility to engage in discussions about new HA legislation and guidelines. By raising relevant concerns and questions, it will become possible to influence future agency requirements, thus improving the potential for a successful implementation with fewer subsequent updates. Such influence and impact will be highly beneficial for any pharmaceutical company and agencies alike, thus creating value across the industry.

Tools for Regulatory Intelligence

As illustrated in Circle 1 of Figure 1 above various RI sources exits, and the sources are dependent on which product portfolio, therapeutic area and market/patient group a company targets. The first step towards being on top of the “hunting game” is to establish a well-functioning flexible system to monitor regulatory agencies’ websites. This is particularly relevant when operating in major markets as the agencies of these (e.g. EMA in EU and FDA in US) actively use their website for communication and updates, focus areas, frameworks, process guidance etc. Additionally, social media must be leveraged to search for updates, and RI staff must attend local conferences and other events where authority representatives will be present.

In many parts of the world, local HAs are not yet as mature and transparent, as e.g. EMA and FDA. Language barriers can be an obstacle to transparency, as guidelines might be published in local foreign languages such as Arabic, French, Portuguese, etc. However, establishing strong relationship with third parties, hereunder local distributors and agents, are crucial for successful business operation in these parts of the world. Therefore, if possible, it could be valuable to hire scientific or professional translating personnel to ensure smoother interaction with the foreign local collaborators and decision-makers, translating relevant legislations.

Many associations publish white papers and blog posts on various topics within RA, e.g. EFPIA https://www.efpia.eu/. It is crucial to keep an eye on those, or even better, become an active member of the associations yourself. By becoming a voice of your pharma company and the life science industry as a whole, you will be capable of influencing guidelines and regulations at an early stage.

It is critical for global RA organisations to have a well-established RI system in place, including operational procedures and communication processes, to capture local RI “prey”, thus ensuring continuous RI exchange between affiliates and headquarters. A fully functional RI system is of uttermost importance, regardless of the size of the pharma company and affiliate. Nevertheless, it does become increasingly important in small markets with less agency transparency, as there are limited opportunities for monitoring local agencies’ websites and social media channels.

The regulatory landscape is under constant development and change, with numerous sources for RI management, wherewith a company should always be looking into improving/optimising current systems and processes. Perhaps Artificial Intelligence could be utilised to ease some of the more manual and time demanding RI tasks? Stay tuned for my next blog post, which will elaborate on this topic.

About the author — Mette Leth Schousboe, PhD, Senior Regulatory Lead

Phone: +45 31 21 64 50, email: msch@baselifescience.com

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