Navigating regulations to launch OTC consumer health products
It is a major operation to launch a new product into the consumer healthcare market and there are many components that need to work cohesively to achieve success. From a planning perspective, mapping the roll-out of an innovation based on consumer needs and ability to execute in market are key, but an often underestimated part of the process is navigating the regulatory environment.
It is important to look carefully into regulatory affairs that affect your product in your local market, and in wider markets when you’re looking to expand. As a central Innovation function, my team works closely with Global Regulatory colleagues to ensure we understand the many compliance intricacies that need to be considered at both local and global levels.
Here are some considerations on how to navigate regulations:
Understand what the end goal is for the product
Mapping the product roadmap and working towards clearly defined milestones not only lays out ambition but provides tangible goals for you and your team. This process should be used for a brand-new product, and when considering alternative, credible applications for existing ones too. Research from Enterprise Nation, commissioned by RB, found that 77% of British small businesses want to drive growth by repurposing their existing products. For example, this could be taking a medical device, such as a thermometer, and re-engineering it to compliment a pain-based medicinal brand.
Weigh-up pros and cons for different classifications
One of the biggest challenges with any global launch is navigating product classifications, as they vary from region to region. Taking a sore throat product as an example, when developed for the UK market, it could be classified as a medical device or a drug. However, as my global regulatory colleagues advise, when rolling out into different markets such as the US or China, it could be considered a monographed medicine or health food, respectively.
The product’s change in classification would impact its formulation, the supporting test data needed and registration requirements. This could set a smaller producer back by five to seven years when trying to enter a new market.
Outline the regulatory framework strategy
Anyone can undertake desk-based research to find out regulatory details, but this isn’t the hard part. It’s important that regulations are interpreted and actioned in the right way – that’s the real skill that takes mastering. You could potentially waste years of effort pursuing a development programme, only to realise you’ve gone in the wrong direction.
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The speed of launch into a new market accelerates dramatically where a company seeks help from experts with dedicated regulatory teams. They will understand different markets and can help make ‘conscious decisions’ about what is the right regulatory strategy. For example, is it worth creating the information now to register in Brazil, when you may not be looking to do this for another three or more years.
Get close to the authorities in proposed market(s)
Regulators are approachable and will engage in conversation. However, the trick is knowing the right questions to ask to get the information needed to support a launch. This really does matter. Questions can’t be sweeping, they must be specific, tailored to your product and prospective classification and market. It can take years to build up close relationships with regulators and understand how they work. So, if you’re not in this position, the registration process will likely be a slow one.
Ensure continued compliance after launch
With any product launched into market, a company is legally and ethically responsible for compliance. That’s why regulatory considerations don’t just stop once a product is launched – there are challenges to navigate throughout the entire shelf-life.
For example, a change in legislation can require additional supporting documentation or an update to the product itself. Where issues arise with consumers, the governing body, such as the Medicines and Healthcare Products Regulatory Agency, will need to be updated and products will need to be checked to ensure they’re safe for public use. For medicines, registrations also need to be renewed annually. It is therefore essential to stay at the forefront of legislation, know how the product is performing in the market, and keep close to regulators.
Consider seeking out expert advice to help navigate regulations
While you may have the most innovative idea for a new product or breakthrough ideas on pivoting the use of an existing one, navigating the regulations to bring a compliant product to market can be a minefield.
We’ve seen first-hand how companies’ progress can be hampered by the regulatory environment. That’s where finding a partner to help you in this process helps. In as little as 12 months, an agile partnership can deliver a new product to market.
While it may be a daunting prospect to pitch to a corporate, there’s a lot to gain in terms of navigating regulations, market expertise, product development and more. Equally, finding a partner who is on the lookout for fresh ideas to grow into innovative consumer health products, creates a win-win situation.
NHS trials test that predicts sepsis 3 days in advance
A new test that can predict sepsis before the patient develops symptoms is being trialled at a National Health Service (NHS) hospital in the south of England.
Clinicians at Portsmouth’s Queen Alexandra Hospital are leading medical trials of the blood test, which they hope will help them save thousands of lives a year.
The test is being developed by government spin-out company Presymptom Health, but the research began over 10 years ago at the Defence Science and Technology Laboratory (Dstl). This included a study of 4,385 patients and more than 70,000 samples, the largest study of its kind at the time.
From the samples taken, a clinical biobank and database were generated and then mined using machine learning to identify biomarker signatures that could predict the onset of sepsis. The researchers found they were able to provide an early warning of sepsis up to three days ahead of illness with an accuracy of up to 90%.
Unlike most other tests, Presymptom Health identifies the patient’s response to the disease as opposed to detecting the pathogen. This is an important differentiator, as sepsis occurs as a result of the patient's immune system’s overreaction to an infection or injury, which can then cause life-threatening organ dysfunction.
Worldwide, an estimated 49 million people a year contract sepsis, while in the UK almost two million patients admitted to hospital each year are thought to be at risk of developing the condition. If Presymptom's test is effective, it could save billions of pounds globally and improve clinical outcomes for millions of sepsis patients.
The initial trials at Queen Alexandra Hospital will last 12 months, with two other sites planned to go live this summer. Up to 600 patients admitted to hospital with respiratory tract infections will be given the option to participate in the trial. The data collected will be independently assessed and used to refine and validate the test, which could be available for broader NHS use within two years.
If successful, this test could also identify sepsis arising from other infections before symptoms appear, which could potentially include future waves of COVID-19 and other pandemics.
Dr Roman Lukaszewski, the lead Dstl scientist behind the innovation, said: “It is incredible to see this test, which we had originally begun to develop to help service personnel survive injury and infection on the front line, is now being used for the wider UK population, including those fighting COVID-19.”