All regulatory affairs professionals are aware that keeping up to date with the global regulatory environment is an essential part of the day to day job description. There will be someone on your team, no matter how large or small, responsible for monitoring the thing that is the world wide web in order to extract data pertinent to your product portfolio. The information extracted from various external repositories is reviewed, assessed, collated, analysed, processed, interpreted, communicated and archived as regulatory intelligence.

Internal regulatory data and intelligence is an often forgotten, yet critical source of information. Every organisation’s electronic files provide a rich source of data for strategic registration planning and policy creation. Those regulatory team members searching for “intelligence” must be able to access and review historical interactions coupled with product and registration data such as:

  • Average time from submission of new application/registration or change request until health authority approvals
  • Previously received queries from health authorities and acceptance of company responses
  • Quality and quantity of interactions with specific health authority personnel as relationships are developed
  • Which products with the same or similar modification were managed successfully in order to support change impact assessments
  • Which implemented regulatory strategies in the targeted regions were not successful and required re-submission or withdrawal
  • Colleague experiences during execution of previous roles
  • Lessons learned following major regulatory project activities
  • All registration history for all products across all marketed regions

Without a centralised repository for product and registration data, regulatory affairs teams will struggle to quickly and efficiently obtain the strategically valuable key information unique to their organisations that is essential to provide thorough and complete regulatory guidance to business executives. Do not allow a flawed regulatory strategy, due to lack of accurate internal data, be accountable for missing key regulatory targets which impact your revenue stream and deprive patients of life enhancing products.

KimYoung@instem.com

K Young