How do you get innovative products to market faster when regulations may be a hurdle and moving down the product development pipeline can take significant time?
This is becoming the key question across industries as the regulatory landscape changes faster than ever before to catch up with recent new trends and scientific and technological advancements. These advancements, many of which we couldn’t even imagine five years ago, are enabling more (and faster) product innovation, which in turn, leads to new categories and more products on the shelf.
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Accompanying these market changes, regulations are modernizing across agencies, industries, and sectors, including chemicals, ingredients, formulas, and finished products.
In some categories, regulations have been stagnant for years, even decades, and their modernization has the potential to be very disruptive to regulatory departments. Especially considering regulatory teams are rarely granted new resources or tools to handle the increased workload.
In this post, we take a closer look at what regulations catching up to industry advancements means for regulatory professionals like us.
Chain Reaction Leading to Regulatory’s Modernization
All around us - from pesticides to skincare to detergent - advances in science and technology are driving the creation of new products faster than ever before. Competitors keep raising the bar to meet increasing consumer demands and differentiate themselves, while also remaining compliant with regulations. All while keeping speed to market a priority.
This now frequently repeated cycle creates a chain reaction where companies are left scrambling to keep launching innovative products while complying with new and/or more complex regulations and regulatory submissions.
How efficiently we regulatory professionals work directly impacts our companies’ ability to get the most innovative products to market first.
New Product Categories Driving Regulatory Modernization, Creating Additional Work for Regulatory Affairs
When new regulations are imposed, we regulatory professionals first must evaluate how it will impact our products and upcoming launches, and identify new ways we must work moving forward to remain compliant. Typically, new regulations require additional effort to be compliant, which demands increased efficiency to ensure we can still meet our launch dates.
For example, your company may be one of the many with CBD products in their development pipeline to jump on this hot consumer trend. CBD is creating entirely new product categories across multiple industries, with regulations across agencies fast following. Or relatedly, your company may have products that fit within the new “Self Care industry” and must consider the new regulatory framework and requirements that are emerging in response, such as the Self Care Regulatory Framework in Canada or the FDA Food Modernization Act.
Regulatory modernization is requiring more sophisticated strategies to ensure compliance across testing, safety, and claims, including but not limited to:
- an increased number of submissions with added complexity
- additional data to be collected and submitted
- more restrictions and scrutiny on claims and substantiation
All of these will take from the already limited time and resources of companies’ regulatory teams. However well organized, your tracking spreadsheet is unlikely to be able to keep up and you’ll need to explore new business solutions.
Scientific Findings and Advancements Drive Regulatory Updates
Not all regulatory modernization is driven by net-new innovations. In some cases - like with animal testing - new norms and regulations are coming about because of scientific advancements.
Animal testing that once substantiated product safety is now heavily restricted by regulation at the state or country level. This shift was enabled by science; new test methods that did not rely on animals were accepted and then became required in subsequent regulatory updates, such as the EPA's Acute Toxicology Six Pack.
Regulatory modernization may also mean new restrictions on existing ingredients and claims. Ingredients once commonly used may now or soon be restricted, or even put your product in a whole different regulated category, with different requirements for compliance.
For example, terms like “natural” “local” and “organic” all have different definitions and levels of regulations in the US, but distinct rules in other major markets like Canada or the EU. Increased interest from consumers in what qualifies food, beauty, and other products for these labels is putting pressure on regulatory agencies to refine their definitions.
Increasingly common scenarios like these mean companies must continuously evolve with the changing regulatory landscape, and faster than ever before.
Does your team have the capacity and the systems in place to quickly understand and comply with what will be multiple levels of new regulations? Talk to one of our regulatory modernization specialists to learn what market leaders are doing in this area.
Regulatory Affairs Must Modernize Along with Agencies
In sum, science, technology, and new regulations work in tandem. Sometimes, science and technology lead to product innovation followed by regulatory modernization. Other times, new regulations demand advances in science and technology to support them.
For us regulatory professionals to keep up, we must be willing to modernize how we work - from our processes and workflows to how we prepare our submissions and dossiers - in order to efficiently meet new and changing regulatory requirements.
Updated on January 1, 2022