Here we introduce a topic that can be seen as somewhat onerous, however it is vital for the compliance of both products and processes within the pharma industry.
The Drug Information Association (DIA) defines Regulatory Intelligence (‘Reg Intel’) as; the act of gathering and analysing publicly available regulatory information.
Life Science professionals routinely access Regulatory Intelligence resources in order to understand the requirements of complex guidelines and industry standards in areas such as clinical trials, Marketing Authorisation Applications and manufacturing requirements amongst other categories.
Regulatory Intelligence is not limited to the understanding and interpretation of Directives and Regulations, it stretches beyond this to lend itself to effective Regulatory strategy and purposeful monitoring of the Regulatory landscape for any changes and assessment of potential impact.
The various sources of Regulatory Intelligence can range from accessing Agency websites, attending training, reviewing publications and signing up to news feeds from relevant websites. Useful examples of Regulatory Intelligence sources includes, but is not limited to, CMDh, EMA, Agency websites (e.g. MHRA, HPRA, MEB etc.), PharmaTimes and TOPRA.
‘Big Pharma’ often have departments dedicated to this area of compliance, responsible for reviewing the impact of new or changing guidance and work to include this information on internal systems developed for the purpose of tracking worldwide and country-specific intelligence. While smaller companies and start-ups may have individual’s data gathering as a small part of their role in a project or submission. An alternative option would be to outsource this function or subscribe to use specialist Regulatory Intelligence databases in order to monitor specific topics.
Country intelligence is an aspect of Regulatory Intelligence, and it is essential for Regulatory professionals to stay vigilant to local guidance. This can sometimes be more difficult to access since it can be related to local procedures that have limited guidance. It can therefore be extremely beneficial to engage in country-level networking opportunities, take part in Agency Seminars, attend Q&A sessions, and generally keep an ear to the ground during times of change.
Fusion Pharma takes an active interest in keeping abreast of changes in the Regulatory environment and provides expertise in Regulatory Intelligence for Drugs and Biologics.