Cannabinoids

Ensuring product quality, safety, and efficacy

A greater understanding of the science behind cannabinoids is opening an exciting new opportunity for medical discovery and the healing power of medicinal cannabis and cannabidiol (CBD) to support human health and well-being.

 

Broughton is an independent life sciences contract research organization serving a global roster of clients across a range of active ingredients including cannabis and CBD. With over 15 years of analytical testing experience in UKAS accredited, GMP, and GLP laboratories, we offer a fully integrated service including on-site stability storage facilities and consultancy on formulation, chemistry toxicology, clinical and behavioral studies, as well as regulatory support. Our facilities are inspected annually by UKAS to ISO 17025 to assess our ability to generate precise and accurate test data.

As the holder of a UK Home Office controlled drug license, we offer a wide range of services for both medicinal cannabis and CBD.

  • Regulatory consultancy currently focused on the EU and UK cannabis regulation
  • UK and EU Novel Food Application scientific consultancy and analytical testing support for full applications, filling gaps in an existing application or responding to a deficiency letter from regulatory authorities 
  • Stand-alone toxicology consultancy services
  • Stand-alone stability study services
  • Product realization services such as designing for regulatory approval, gap analysis for chosen regulatory pathways, product optimization, reformulation, etc.
  • Aerosol and vape consultancy and testing
  • Method development, validation, and technology transfer

Download our Medicinal Cannabis and CBD Services Brochure

Cannabis Analytical Testing

  • Cannabinoid Potency Testing for CBD and THC as well as CBN and CBG
  • Terpene Profile Testing related to product taste, aroma, and consistency
  • Pesticide and Mycotoxins Testing
  • Residual Solvents Testing
  • Heavy Metals and Nutrients Testing
  • Microbial Contaminants Testing
  • Vitamin E Acetate Testing

 

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Choosing the right regulatory pathway

The rapid growth of the cannabinoid industry presents a unique opportunity for companies to innovate new products and provide novel solutions for the advancement of human health. The industry's growth has been so rapid that regulation is continuously evolving to keep pace. There are various pathways to market for medicinal cannabis and CBD products and finding the most suitable one can be a complex task for potential manufacturers and suppliers. 

 

The simplest way for manufacturers to understand the route to market may be to determine whether their product falls under the medicinal product pathway and is making a medical claim or should be licensed under a non-medical regulatory pathway.  Medicinal products can make medical claims to treat or prevent disease, including an injury, ailment, or adverse condition. The potential for marketing claims highlights one of the marked differences between a product under the medicinal product pathway and more consumer-orientated non-medical pathways.

Consumer Cannabidiol (CBD) Products


In many markets, cannabidiol (CBD) is no longer classified as a controlled drug, and demand for CBD products is soaring due to an increased awareness of its healing properties and health benefits. It is important to note that there are some markets where CBD is still not legal.
In 2019 the novel food regulation was designated a suitable regulatory pathway for the portion of CBD products defined as food in the UK and European Union (EU). The definition of food is any substance or product, whether processed, partially processed, or unprocessed, intended to be, or reasonably expected to be ingested by humans. More specifically, novel foods are foods that have not been widely consumed by people in the UK or EU before May 1997.
UK and EU Novel Food Application.

There are several CBD product categories that sit outside the Novel Food Regulations.
  • CBD vaping products have no required regulatory compliance. It has been suggested that these products may be assessed as part of the third iteration of the Tobacco Products Directive (TPD); however, this has not been confirmed, and currently, these products are outside the scope of the TPD legislation.
  • CBD patches have no required regulatory compliance
  • Cosmetics such as topical creams are regulated under existing cosmetic regulations (REGULATION (EC) No 1223/2009, 2009).

Read more about the Legal Status and Regulatory pathways to Market for Cannabinoid Products in the UK Market

 

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Medicinal Cannabis


Medicinal cannabis development is still in its infancy but government health bodies, research institutions, and medical practitioners are increasingly interested in the medicinal and healing properties of the Cannabis sativa plant which contains over 400 chemical entities of which more than 60 are cannabinoid compounds, some of with opposing effects.

Regulatory pathways for medicinal cannabis vary considerably between countries. However, in some jurisdictions, there is a growing trend toward increased research and development into new medicinal cannabis drugs and the collection of real-world evidence to support the treatment of conditions such as chronic pain, epilepsy, multiple sclerosis, and anxiety through cannabis-based medicines.


In the UK, the medicinal product regulatory pathway can be split into three categories.

  1. Unlicensed cannabis-based products for medicinal use in humans (CBPMs)
  2. Licensed CBPMs
  3. Licensed cannabis-based medicines


Read more about the Legal Status and Regulatory pathways to Market for Cannabinoid Products in the UK Market here

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