In the complex and highly regulated field of pharmaceuticals and biotechnology, Regulatory Affairs play a pivotal role in ensuring the appropriate submission of regulatory documents to health authorities. However, the emergence of artificial intelligence (AI) has presented an opportunity to streamline various tasks within regulatory affairs, offering potentially enhanced efficiency and speed. In this story, we take a close and informed look at how artificial intelligence may be reshaping the medicine industry.
Manan Shah, a consultant, is considered one of the most efficient and innovative executives in the domain of Regulatory Affairs in the US and is deemed as the go-to professional by some of the greatest pharmaceutical and biotech organizations.
We talked to Shah and in his experience, AI has the potential to be incorporated in different workflows and processes. He explained that while AI holds promise in expediting operational tasks, careful planning and consideration are essential due to the potential impact on patient care. Regulatory Affairs, in this regard, encompasses strategy and operations in a wide range of areas including submissions, publishing, CMC (Chemistry, Manufacturing, and Controls), clinical and preclinical, advertising, promotions, labelling, and more. When documents are submitted as part of a product dossier, for instance, these regulatory submission documents undergo manual processes such as hyperlinking and formatting to meet the requirements of relevant health authorities but with the integration of AI technologies, Shah said, “the potential to revolutionize this process has been unlocked.” With AI, these tasks could be accomplished in a matter of minutes, delivering the desired output for health authorities, having the potential to significantly speed up the preparation, submission, and review of regulatory dossiers, ultimately expediting the approval of medicines and benefiting patients.
To establish a fair understanding of what Manan Shah’s workflow and responsibility look like — he sees to it that the products (drugs, biologics, vaccines) being introduced in distribution for consumers are in compliance with applicable laws. He was one of the consultants who supported emergency use authorization in response to the Pandemic, which makes him an indispensable resource for any situation that needs a quick turnaround of the data needed for securing approvals from global regulatory authorities. In essence, he contributes by extending the boundaries of the international pharmaceutical and biotechnology sectors, while ensuring compliance with regulations.
Shah further emphasized the importance of exercising caution during the implementation of AI in regulatory affairs. “While AI can offer tremendous efficiency, it is still prone to errors. Quality control (QC) remains an industry-wide practice and a crucial step before submissions are made to health authorities and even with the adoption of AI, QC is essential to ensure the accuracy and reliability of the regulatory documents” — Shah shared. “Although AI systems are capable of self-learning, human oversight is necessary to prevent potential errors that could have an adverse impact on patient care,” he crucially added.
The healthcare industry, both internally and in its interactions with health regulators, has tremendous potential for progress with the implementation of AI while it is crucial to strike a balance between the benefits of AI and the need for human expertise and judgment. While AI can expedite operational tasks, the likelihood of completely replacing the expertise and decision-making capabilities of regulatory professionals stands far-fetched. Instead, AI should be seen as a supportive tool that can supplement and enhance existing processes, Manan explained.
In all reality, the integration of artificial intelligence (AI) has the potential to streamline various tasks within regulatory affairs in the pharmaceutical industry and the ability to automate processes. AI can expedite the preparation, submission, and review of regulatory dossiers, ultimately benefiting patients by accelerating the approval of medicines. However, the constant bottom line remains that careful planning, quality control, and human oversight are crucial in biotech and pharmaceutical regulatory affairs to ensure the accuracy, reliability, and safety of AI-supported regulatory processes.