Kindeva Drug Delivery
From Complex to Compliance: 3 Keys for Unlocking the Regulatory Pathway
Nicholas Smalley
The pharmaceutical industry spends billions of dollars on R&D every year, resulting in an interesting and dynamic business where innovative new ideas and concepts to improve human health are created daily. However, one of the biggest challenges of this on-going innovation for the regulatory professional is how to guide organizations to effectively develop their newest complex drug product so it can be approved for use. Across my career, I have found three key things help navigate this process:
1. Do the Right Thing
At the very end of every pharmaceutical development is a patient. It might be you, your parents, or your children, so even where guidance is available, the priority should be to maximise the benefit while minimising the risk. From concept to launch, developing a new drug product is risky, so you must base your programme on doing the right thing.
Most regulatory guidance is grounded in history and what has come before, so it may not apply to your novel technology. In the absence of specific guidance or in the struggle to balance conflicting requirements, I have found the soundest position from which to start is putting the patient first. Always challenge yourself by asking, “Are we doing the right thing?”
Regulatory regimens are only interested in your product's quality, safety, and efficacy. So, if you can justify that your development programme is in the patient's best interests, then you stand a much better chance of getting regulator agreement and approval, irrespective of any prevailing guidance. In this situation, the regulatory professional's skill is putting together patient-centric justification and explaining why what was done was the right choice.
2. Collaborate and Network
Most regulatory authorities are reactive rather than proactive regarding guidance and advice, so regulatory professionals need to empower themselves to guide their companies through the development minefield. One of the best ways to do this is never to miss an opportunity to interact with regulators.
Many regulatory authorities have pre-submission or pre-development meetings, which are excellent opportunities to explain a new product and highlight the potential patient benefit.
On a more general note, regulators often speak at conferences, and many authorities run their seminars on various topics, so build your network whenever you can. Take every opportunity to get to know your regulators and strengthen that critical regulatory partnership. You may not get all the answers you want from these interactions.
Nonetheless, early and regular engagement with regulators gives you a seat at the table, which becomes particularly important when you have something novel to discuss. You will have multiple opportunities to educate regulators throughout the development and licensing process, but it is best to begin your regulatory collaboration early, before data submission or before they are generated.
One of the biggest challenges of this on-going innovation for the regulatory professional is how to guide organizations to effectively develop their newest complex drug product so it can be approved for use.
3. Create Clarity
Always remember that you are the expert on your technology or product, not the regulators. Many regulatory professionals mistakenly believe that questions from authorities come from a position of wisdom and greater knowledge. They incorrectly assume that regulators clearly understand everything they are presented with, so questions from them must be a critique.
It is likely that regulator questions come simply from insufficient understanding and a lack of clarity regarding the information presented. Sometimes, the issue is one of terminology, as an entirely new technology improperly explained offers false or insufficient understanding for regulators. The best regulatory professionals can clearly explain their product and its benefits in language that regulators understand and can point regulators to the data supporting their arguments.
Seeking Success
Regulatory professionals are the essential link connecting product development and compliance, ensuring both are synchronised throughout an often lengthy process. By ensuring solid communication with regulators and remaining committed to patients' best interests, there is an opportunity to smooth the pathway. While the process can be complex, your new product will benefit the world, so every effort you make to approve it is worthwhile.
