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.
Bachem turns 50 - a timeline
Bachem, a supplier to pharmaceutical and biotechnology companies worldwide, is celebrating its 50th anniversary this month. We take a look at the Swiss company's history.
1971 - beginnings
Bachem is founded by entrepreneur Peter Grogg in Liestal, a small town near Basel in Switzerland. Grogg started the firm with just two employees, and with a focus on peptide synthesis - peptides are composed of amino acids that have a variety of functions treating health conditions such as cancer and diabetes.
1977 - 1981 - early growth
Bachem moves its headquarters to the Swiss town of Bubendorf, with eight employees. In 1978 the company produces peptides for use in medicines for the first time. In 1981 production capacity triples and the workforce grows to 150.
1987 - 1996 - worldwide expansion
The company expands into the US with Bachem Bioscience, Inc. in Philadelphia. To strengthen its presence in Europe, Bachem opens sales and marketing centres in Germany in 1988.
Further sales centres open in France in 1993. By 1995 the company employs 190 people. In 1996 it acquires the second largest manufacturer of peptides in the world and forms Bachem California with a site in Torrance.
1998 - 2003 - Bachem goes public
Bachem company goes public and lists shares on the Swiss Stock Exchange. Further acquisitions include Peninsula Laboratories, Inc, based in California, and Sochinaz SA, a Swiss-based manufacturer of active pharmaceutical ingredients. By 2001, the company has 500 employees and sales reach 141 million CHF.
In 2003 the organisation is given a new legal holding structure to support its continued growth, which remains in place to this day.
2007 - 2013 - acquisitions
Bachem acquires a brand by Merck Biosciences for ready-to-use clinical trial materials and related services.
In 2013, together with GlyTech, Inc. Bachem announces the development of a new amino acid that can help to treat multiple sclerosis, with a world market of more than $4 billion.
In 2015 it acquires the American Peptide Company (APC), which becomes integrated into Bachem Americas.
2016 - 2019 - a global leader
In 2016 the group opens a new building dedicated to R&D projects and small series production in Bubendorf. With a total of 1,022 employees, the workforce exceeds the 1,000 mark for the first time in the company’s history. Sales are over the 200 million mark for the first time at 236.5 million CHF.
Bachem expands into Asia with the establishment of a new company in Tokyo called Bachem Japan K.K.
By 2019 Bachem has a growing oligonucleotide portfolio - these are DNA molecules used in genetic testing, research, and forensics. It is hoped this will become a significant product range in the future.
2020 - COVID-19
Despite the COVID-19 pandemic, Bachem secures its supply of active ingredients, and even increases it in critical areas. Sales exceed the 400 million Swiss franc mark for the first time, and 272 new employees are hired.
2021 - a milestone anniversary
Bachem celebrates its 50th anniversary and position as a global leader in the manufacture of peptides. While it remains headquartered in Bubendorf, the company employs 1,500 people at six locations worldwide. In the next five years there are plans to continue expanding.
Commemorating the company's anniversary, Kuno Sommer, Chairman of the Board of Directors, said: "Bachem's exceptional success story from a small laboratory to a global market leader is closely linked to Peter Grogg's values, and has been shaped by innovation, consistent quality and cost awareness, as well as by entrepreneurial vision."