March 15, 2023

Drug development is costly. According to a study by the German Cancer Research Center (DKFZ), costs range from $161 million to $4.54 billion. One reason for these high costs relates to the safety requirements for drugs. Every drug must prove its efficacy, safety and pharmaceutical quality in an approval process. This approval must be renewed at regular intervals. This includes checking whether the medical benefits continue to outweigh the possible risks. In addition, the marketing authorization holder is obliged to declare any revisions to the drug, e.g., due to new scientific findings. This is more often the case than one might think. It is therefore not surprising that this aspect of drug development plays a particularly important role. 

The Regulatory Affairs (RA) team is responsible for carrying out the approval process and all related activities for each country in which the drug is to be distributed. As the requirements of the respective country authorities change regularly, monitoring of any changes made to the requirements is essential. Any errors in the regulatory submission process will result in delayed market approval and, consequently, delayed market entry and lost sales. 

Obtaining and evaluating regulatory information is referred to as Regulatory Intelligence. The process includes selecting relevant data sources, obtaining the data, evaluating the data, and finally aligning the regulatory strategy and determining responses to new regulatory requirements. Continuous monitoring of the regulatory environment also enables timely adaptation of the strategy to future regulations and legislation.

Usually, a large part of these tasks is performed by the specialists of the Regulatory Affairs (RA) team. The RA team ensures regulatory compliance and quality control in the face of ever-changing local and global requirements. However, gathering regulatory information and then assessing its relevance, as well as making it available in internal databases, represents a significant amount of work. Time and effort that is needed elsewhere.

The use of advanced AI systems would help save time so that more time can be spent on actual regulatory activities, thereby gaining competitive advantage. In particular, intelligent processing helps companies anticipate global regulatory developments.

A centralized database simplifies access to regulatory information within the company. Smart tools learn to distinguish relevant from non-relevant regulatory information and thus simplify the assessment. Smart processes further simplify all related activities by providing suggestions for contact persons as well as for the further course of action. AI-assisted regulatory intelligence solutions therefore offer the following benefits: 

• Increased efficiency

Automated collection and analysis of regulatory information and automatic generation of intelligent reports and summaries aligned with the product spectrum and the countries concerned increases efficiency in both Regulatory Affairs and R&D and Pharmacovigilance.

• Cost reduction

Reduce operational overhead through increased efficiency in the capture of regulatory information and the execution of related processes.

• Mitigation of regulatory risks

Trend analysis procedures allow the anticipation of future regulatory developments and the proactive preparation and early implementation of responses to changes.

AI-supported Regulatory Intelligence solutions assist pharmaceutical companies in the challenge to keep pace with the increasing amount of regulatory information. Through comprehensive analysis capabilities, they can move away from a reactive to a proactive approach to regulatory information.

Inconsult offers pharmaceutical companies tailor-made solutions in the area of Regulatory Intelligence. Get in touch with us, our experts Dr. Stefan Hock (Head of Regulatory Affairs) and Dr. Matthias Rüdiger (Head of AI) are at your disposal.