Example – Bringing a new medicine to market:
Based on our insights and history of precedents, we advise using the following steps to help verify the viability of the regulatory strategy.
1: Evaluate Product Attributes and Potential Regulatory Liabilities
We would look to quantify the attributes of a potential medicine to evaluate the regulatory implications of its use, design, and performance.
The attributes we will typically consider are relating to the following:
- Intended use (users, pathology or pathologies addressed, environment, patient populations)
- Design (functionality and mechanism of action)
- Claims on label/Target Product Profile
- Competitive set – benchmarking other products
- Target markets
- Data to support claims and meet regulatory objectives (arising from existing or ongoing development studies)
- Previous regulatory history, client product or class effect
- Post-market issues (e.g., legal liability)
- Post-approval commitments
2: Highlight Possible Strategies
In this phase, we will analyse the potential medicine in light of the aspects previously researched. The goal is to determine if any issues are likely to come up from a regulatory standpoint, and how to best address them.
Analysing past submissions will provide insight into past strategies that have either succeeded or failed.
Risks, critical assumptions, and any barriers to approval should be documented. This documentation will provide insight into how previous or current requirements may impact the product development timeline.
3: Strategy Review
With the strategy in draft form, we will evaluate the strategy to ensure that it reflects the Target Product Profile and any desired claims and goals you identified at the beginning of the process. We will outline the hurdles involved with the proposed strategy and understand your company’s tolerance for risk.
At this stage, it may be appropriate to consult with regulatory authorities to gain clarity regarding the chief key components of the regulatory strategy. This is often done in the form of formal scientific advice, through briefing books and regulatory authority meetings, which JensonR+ Limited can support you with.
Once a strategy has been agreed, it needs to be widely communicated and implemented. The regulatory environment is dynamic, so any regulatory strategy needs to remain fit for purpose and therefore be regularly reviewed, changes agreed and cascaded to all departments.