Pharmaceutical regulatory policy is critical in ensuring the safety, efficacy and quality of drugs worldwide. Modern medicines are stringently regulated at every stage of the drug development process. At life sciences companies, regulatory intelligence (RI) teams act as a bridge with international regulatory bodies to drive ongoing compliance with policymakers. However for RI professionals, responsibilities have grown over recent years. From drafting and submitting applications to authorities, to strategically analyzing regulations relevant to the development, approval and maintenance of drugs – this evolution demonstrates one of many shifts within the global regulatory landscape.
“I started in regulatory intelligence 15 years ago. Back then, the emphasis was on being able to find and catalog information, rather than having a deep understanding of it. Over time there’s been a shift to our professionals becoming trusted advisors, understanding information well enough that they can advise on its potential significance.”Iain Todd, Principle Regulatory Intelligence Executive at GSK (in an interview with InfoDesk)
So, how did the regulatory landscape become what it is today, and how can RI professionals prepare for the landscape of the future?
The history of the global regulatory landscape
The regulation of modern medicines can be traced back as early as 1848, when the pharmaceutical breakthroughs of the 1800s saw drug import regulations first written into US law. But it wasn’t until almost a hundred years later that drug development picked up pace, catalyzed by the widespread infection and disease of World War II. This unprecedented surge in the need for medicine outpaced the growth of scientists’ pharmaceutical knowledge base, and a number of disasters ensued. With each new disaster, reactive regulations were hurriedly drawn up; landmark regulations include stricter product labeling requirements and anti-tampering regulations to ensure the protection of public health.
As a result, the life sciences industry was the first to be significantly regulated, led by the US due to its size and scientific advancement in the medicinal market. Nowadays, the US Food & Drug Administration (FDA) comprises over 18,000 employees, having doubled in size in the last decade. So, what does this tell us about the state of the global regulatory landscape today?
Click here to download our latest infographic, which takes a deep dive into the origins and milestones of pharmaceutical regulation to uncover how this rich global history is shaping the landscape of tomorrow.
The current challenges of the global regulatory landscape
In recent years, the global datasphere has been expanding at an exponential rate. The regulatory landscape is no exception, with a 150% increase in the number of regulatory mandates issued annually over the past 5 years. To put that into perspective, that’s over 23,000 new guidelines each year, which translates to 442 each week, or one every 22 minutes.
The regulatory landscape is also growing increasingly complex. Recent changes such as Brexit and Swiss-exit are widening the gap between various global authorities, as former blanket policies develop regional discrepancies.
“Today’s regulatory professionals must understand not only the regulatory guidances for each geographical market in the world, but also the hot button issues that affect the review of new drug applications in these regions.”Gary Buehler, VP of Global Regulatory Intelligence and Policy at Teva Pharmaceuticals (in an interview with Life Science Leader)
Today, international regulatory sources are not only increasingly saturated with data, but are growing in quantity and disparity. Faced with an onslaught of information from an innumerate number of databases, social media sources, and health authorities and bodies, teams often lack the time and technological resources to cope. For RI professionals, this poses a critical challenge: how can they monitor, analyze and communicate relevant insights to mitigate the risk of non-compliance?
“Instead of 80% search and 20% analysis, I’d rather do 20% search and 80% analysis.”Immo Zadezensky, Head of Global Regulatory Policy & Intelligence at Moderna (in an interview with InfoDesk)
Despite this, the expectations and pressure placed upon regulatory professionals is increasing. New responsibilities include:
- Devising and deploying a global regulatory strategy to drive forward business goals
- Performing due diligence on both existing and emerging drugs to identify profitable partnership or acquisition opportunities
- Collaborating with Competitive Intelligence (CI) teams to provide a 360-degree view of the market landscape to empower data-driven strategic decisions.
Shaping the future of the regulatory landscape
Following the onset of COVID-19, the saturation and complexity of the regulatory landscape only worsened, and RI teams across the world were forced to adapt to this new normal. Information overload, however, is not the only challenge teams face. The pandemic – once considered a temporary obstacle – has permanently altered the trajectory of the regulatory landscape. As a result, teams must take action to ensure continuity in their drive for compliance, despite huge and lasting disruptions to the drug development process.
The key areas affected by COVID-19 include:
- Clinical trial risk assessments: The urgent need for a Coronavirus vaccine significantly cut the typical Time to Market (TTM) to a fraction of what it had previously been. As a result, clinical trials now take place sooner in the drug development process than they would have historically. This drives an increased need for continuous, real-time risk assessments for these innovative trials, to guarantee patient safety.
- Pharmaceutical labeling: The aforementioned acceleration of TTM triggered increased calls for transparency amongst the general public. As remote work proliferates, this emphasizes the need for open interdepartmental communication and seamless proofing and versioning processes, in order to ensure accurate, consistent and up-to-date drug labels.
- Virtual regulatory meetings: Despite the many benefits of hybrid working, virtual meeting environments may be less effective than traditional face-to-face meetings. To empower effective virtual communication, leaders should plan and rehearse meetings in advance, and ensure their employees attend meetings via software that is unified, optimal, and accessible.
- Remote internal quality audits: In preparation for the disruption of future crises, organizations should implement effective remote internal auditing processes to support uninterrupted business operations.
- Online marketing and crowdfunding: As the world grows increasingly digitalized, promotional and fundraising activities are moving online. The FDA already regulates activities on companies’ websites and social channels, as with physical promotional material – but teams should be aware that online communications regarding pre-approved drugs may face federal regulation next.
Future-proofing your global regulatory strategy
Whilst the complexity and demands of the landscape increase, typically small regulatory teams are becoming strained, increasing the risk of non-compliance. This introduces a critical need for digital transformation. By embedding systematic intelligence procedures, strategies and technologies into the development and commercialization of all drugs, teams will be able to facilitate their growing workload and optimize their workflow.
“You’ve got to understand what you really need to drive your organization forward, and then you have to do the hard work of investigating whether the technology that’s out there really matches up with what you want to do. There’s no substitute for doing that hard investigative work, and that’s the challenge – we’re going to be overloaded with so much new technology that we’re going to have to do some old-fashioned legwork.”Carol Stinson Becker, Senior Global Director of Regulatory Intelligence at AstraZeneca (in an interview with InfoDesk)
3 steps to digitally transform your regulatory strategy
Step 1: Centralize your regulatory data
Invest into a platform that can centralize your internal and external regulatory data into a single, globally accessible source of truth, and categorize this information into topics most relevant to your team’s workflow – be they global regions, therapeutic areas, regulatory bodies or trade associations. Housing your information in this way enables key stakeholders to search for the insights they need, when they need them, empowering data-driven decision-making.
Step 2: Leverage artificial intelligence (AI) and machine learning (ML)
Implementing purpose-built AI and ML into the monitoring, gathering and consolidation of data, can significantly optimize teams’ surveillance of the regulatory landscape. Companies who invest in these advanced technologies stand to gain a huge competitive advantage, as RI professionals benefit from the freedom to perform tasks better aligned with wider business objectives.
Step 3: Analyze, analyze, analyze
Specifically, more time may be dedicated to interpreting insights, maximizing the value of the company’s regulatory data. This empowers teams to devise, deploy and deliver on a proactive global regulatory strategy, driving business success. As such, those working in the field need not fear AI’s takeover – least of all because guidelines are often unclear, and require the nuance of human analysis to “read between the lines”.
“Connected regulatory intelligence can inform regulatory strategies and plans through easily accessible up-to-date market-specific requirements combined with historical data around what regulatory authorities approved or rejected, enabling better more robust planning leading, shortening the critical path to approval across markets and reducing the risk of rework and delays with their negative impact on both cost and growth.”Jens-Olaf Vanggaard, Senior Director of Global Safety, Regulatory and Quality Solutions at IQVIA (in an interview with Pharma Commerce)
The future of the global regulatory landscape is all about data – its saturation, its complexity, and the role of digital transformation in truly maximizing its value. While assimilating new technologies into existing workflows isn’t without its challenges, it is simultaneously impossible to deny the benefits of augmented regulatory intelligence.
So, what are you waiting for? To find out more about how InfoDesk can digitally transform your regulatory workflow, click here.