Regulatory change strategy may be defined as “the comprehensive elucidation of a project designed to achieve a specific regulatory goal, such as to obtain a new approval or clearance of an amendment.”

As global regulatory requirements evolve and become increasingly more complex, a solid regulatory strategy for changes, followed by a determined execution, can maximise the opportunity to achieve the identified regulatory goals and provide the ever-elusive competitive advantage for revenue generation.

A suitable approach to regulatory strategy for product changes begins by engaging with internal cross-functional stakeholders to identify those product attributes that may have regulatory impact such as revised intended use, new target market, additional clinical study requirements, etc. Regulatory teams will then conduct a regulatory intelligence analysis on possible precedents, document the proposed strategy, verify the strategy’s viability and finally by reassessing (and when necessary, updating) the strategy as and when circumstances change.

Consideration must be made on what was been done before, what worked for other organisations and, just as importantly, which prior executed strategies were not successful. Key risks, barriers, critical assumptions, issues or questions must be confirmed or resolved. The strategic process must proactively recognise any challenges that may be responsible for delays for the proposed change implementation. Opportunities for positive engagement with the impacted global regulatory authorities should also be encouraged.

Internal regulatory intelligence is a key source of data for strategic planning. Regulatory teams are required to access and review historical product and registration data such as:

  • All registration history for the impacted products and regions
  • Average time from submission of change request to health authority approvals
  • Previously received queries from HA concerning changes and acceptance of company responses
  • Quality and quantity of interactions with specific HA personnel
  • Which products in a different product family with the same or similar change were managed successfully
  • Which implemented regulatory change strategies in the targeted regions were not successful and required re-submission or withdrawal
  • Lessons learned

Without a centralised repository for product and registration data, regulatory teams will struggle to obtain the strategically valuable key information unique to their organisations that is essential to provide regulatory guidance to business executives. Do not allow a flawed regulatory strategy, due to lack of accurate internal data, be accountable for your change not to happen.

KimYoung@instem.com

K Young