You’re developing an FDA- and/or EMA-regulated drug, biologic, or medical device. Throughout the drug development process, your goal is to get to the next regulatory milestone in the most expeditious way possible. What’s the best way to do this? Using your data to tell a compelling story.
The process of developing a drug, medical device, or biological product is driven by science. In the past, Regulatory Affairs professionals have been seen as “paper pushers,” dealing with the administrative aspects of implementing and enforcing the laws. However, over the past 15 years or so, Regulatory Sciences has evolved and is now one of the lead functions driving drug development and decision making. Today, when it comes to the Food and Drug Administration (FDA) and European Medicines Agency (EMA)/local national agencies, the regulations are written with data in mind, and assume full and accurate data will be submitted.
Across the globe, regulatory-related science has codified what data is needed and how it should be presented. Although the specific processes and procedures for obtaining approval differ from agency to agency, regardless of where you’re seeking to obtain approval, the regulators all seek the answers to the same questions: is it safe and will it work? The goal is to make it easy for the regulators to understand the answers to these questions.
Regulators draw square boxes and expect your data and your product to fit neatly in those boxes, but that is rarely ever possible. However, it is the job of your regulatory consultant to help transform that neat, square box into the right shape for your product using your scientific data to ensure you can still satisfy the regulatory requirements.
With that being said, doesn’t it make sense to aim to generate and submit the most accurate and credible data possible and to use that data to tell a compelling story?
But the importance of science does not stop with regulatory submissions, but rather, it goes a lot deeper than just these applications. Scientific data should be the driving force behind everything you do from a regulatory perspective. For example, it is strongly recommended that Sponsors seek every opportunity to meet and speak with the regulators. During these meetings, doesn’t it make the most sense to speak in a common language to both sides? Yes, the conversation will be rooted in science.
Today's world is full of scientific innovation, with new information and technology being uncovered on a daily basis. However, the regulatory framework that the FDA and EMA follow is fixed, and changing the rules and requirements takes time. Oftentimes, the regulatory framework is not able to keep up with the rate at which novel scientific advances are made in the world of drug development. As you can imagine, this creates issues with regard to the review and approval of new medicines.
While the goal is to evolve the regulatory framework in parallel with these scientific advances to meet the needs of Sponsors everywhere, that is not a quick or easy fix. As such, overcoming these obstacles requires creativity in how the data is presented and submitted. Although the regulations are not identical from one agency to the other, this is an issue faced by regulatory agencies across the globe.
Officials within the FDA and EMA recognize that this time lag exists and are aware of the challenges and issues that are presented due to this issue, but it is not something that can be solved overnight. So, while we continue working to evolve the regulatory framework, the best path forward for Sponsors to set their products up for success is to work with an experienced and science-first regulatory consultant. ProPharma has those experts and is uniquely positioned to help with your regulatory-related needs, at any stage in the product lifecycle, across the globe.
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