Objective: Highlight benefits and challenges of establishing the regulatory intelligence function within a matrix organisation.
Method: Analysis of different tasks performed by the regulatory intelligence function under the remit of its operational activities.
Results: The regulatory intelligence function continuously monitors regulatory information from local, regional and global authorities and organisations in all domain, such as clinical, pharmacovigilance, quality etc. to support other functions within a pharmaceutical company being up to speed and thereby align strategies and/or maintain compliance with the latest regulatory requirements and guidelines for both investigational and authorised products. Regulatory intelligence is an essential part of the regulatory strategy not only at the start of the drug development but throughout the entire life cycle of the product including the pre-submission as well as post-submission phases. In that regard, it is very important for the regulatory intelligence professionals to liaise with the subject matter experts within the company at an appropriate time to align the expectations. In the absence of a regulatory intelligence function, different stakeholder functions would most likely perform their independent intelligence activities and would pick up only critical aspects affecting their roles or interest lacking the complete holistic approach to it. On the other side, subject matter experts also presume that with the existence of a regulatory intelligence function within an organisation they would always receive an authoritative and complete interpretation of national and regional regulations. However, the interpretation and impact assessments of any regulations cannot be completed solely by the regulatory intelligence professional as it heavily relies on inputs from subject matter experts among various stakeholder functions.
Conclusion: Regulatory Intelligence allows to determine the requirements for e.g. global clinical trials, manufacturing, and regulatory procedures, answer strategic regulatory questions and develop a global marketing application of a medicinal product. For regulatory intelligence to perform their task effectively and meet the expectations of all relevant stakeholder functions, it is important to understand the company’s therapeutic interest together with its development strategy and pipeline. This enables the regulatory intelligence professional to identify the critical updates in the ever-changing regulatory landscape and liaise with the subject matter experts in the best possible way. As there might be large differences in regulatory requirements across different regions, it is important to identify and maintain a priority topic list following input from various stakeholder functions. This would help in engaging the subject matter experts in a much more efficient manner in the regulatory intelligence activities, such as conducting impact assessment, as well as policy work, such as providing review comments on draft regulations. Benefits of having the right regulatory information at the right time with the help of regulatory intelligence function will ultimately help in drafting and executing a good regulatory strategy with greater chances of success.

Synergies between Regulatory Intelligence and other functions within pharmaceutical industry

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