Even before COVID-19 changed the way medicines and medical products are developed around the world, regulators were facing a growing number of challenges. Shifting market dynamics and the entry of non-traditional players are just two of the emerging trends that require more time, staff and funding to ensure oversight of compliance and safety. Combined with the ongoing emphasis on making regulatory processes and approvals more efficient, the need for investing in technology to support regulatory activities has never been greater.
Like many other functions looking to technology across the Life Sciences industry, regulatory authorities are searching for opportunities to increase efficiency with automation, platforms that rapidly turn big data into useful information, and intelligent solutions such as machine learning and natural language processing. But implementing technology in the regulatory landscape can be difficult because of limited funding for innovation and a lack of risk tolerance. Regulatory requirements often put safety and efficacy as top priorities, keeping regulatory authorities far from the leading edge. But the dynamics of the current environment are changing all that.
Sharing Data Securely Across Agencies
Many regulatory agencies around the world have already implemented robotic process automation (RPA) and data analytics to help manage some of the fundamental activities involved in overseeing safety and filings. For example, in the U.S., the Federal Drug Administration (FDA) has developed the Technology Modernization Action Plan (TMAP). One of the key components of the TMAP is to help the FDA manage and use data with a focus on collaboration with external stakeholders and interoperability. The TMAP also gives the FDA an approach for using infrastructure, cloud, data interfaces and cybersecurity much like drug developers and pharmaceutical companies in the industry.
Perhaps most importantly, the FDA’s strategy incorporates organizational transformation as well, with a deep understanding that workforce changes are integral to the success of new technology. While the FDA’s fundamental goal remains to ensure the safety and efficacy of products used by the public, the emphasis on technology to drive innovation and efficiency reflects new ways of thinking about how it can deliver value.
Modernizing the Drug Application Process
COVID-19 has also raised the level of collaboration among regulatory authorities around the world. While this is not the primary driver for technology innovation, it is reflected in the overall commitment to modernization. The European Medicines Agency (EMA), for example, is relying more on technology to help advance its PRIME scheme, which was put in place to accelerate the assessment of applications for medicines to meet unmet medical needs. EMA is leveraging technology to:
- Develop expertise in and facilitate the implementation of novel manufacturing technologies
- Enhance transparency and communication with stakeholders
- Address modernization of regulations and guidelines, including through international harmonization activities
- Encourage the use of risk-based approaches to process and control strategies
Shifting from Regulation to Innovation in Medical Devices and Data
In Japan, one area of focus for the Pharmaceuticals and Medical Devices Agency (PMDA) is the use of artificial intelligence (AI) and the internet of things (IoT) to make use of big data, such as health records and clinical data to enhance diagnosis and therapy. A regulatory initiative is also underway to develop a novel framework focused on medical devices. This initiative seeks to implement a paradigm shift from regulation to innovation for the PMDA, facilitating the review and approval of devices that use AI and IoT.
The fact that regulatory authorities around the world are beginning to view technology as a mechanism to modernize the drug and device development process is perhaps the biggest leap forward in modernization in many years. While some of this progress can be tied back to the COVID-19 pandemic, most of these initiatives and the emphasis on global collaboration predate the current health crisis. The benefits available from automation AI and data analytics can empower regulators to achieve their primary objectives of ensuring patient health and safety and manufacturer compliance in increasingly powerful ways in the years to come.
ISG helps Life Sciences companies and regulatory authorities understand the emerging technologies available and the potential impact on their work. Contact us to discuss how we can help your organization.