Medicinal cannabis – How to begin your Regulatory Strategy

Medicinal cannabis refers to a number of different forms of cannabis used for therapeutic purposes.

Medicinal cannabis as a traditional therapeutic – i.e. backed by the typical platform of quality, safety and efficacy data and accompanied by prescribing information – is still relatively new.  So if you enjoy Regulatory puzzles, you are in the right space.

Let’s look at four regulators… At the time of writing…

  • In Australia, the Therapeutic Goods Administration has approved one registered medicinal cannabis product, though has approved over 7,700 applications to access ‘unapproved’ medicinal cannabis under the Special Access Scheme (Category B). Five clinical guidance documents are available (co-ordinated by the Department of Health), and specific regulatory requirements include Therapeutic Goods Order 93 which outlines minimum quality standards. In addition to the federal oversight by the TGA, state and territory-level regulation is also in place.
  • In New Zealand, Medsafe has provided consent to one medicinal cannabis product. Ministerial approval, delegated to Medsafe, is required for cannabis products not approved via the new medicine consent process. The New Zealand Ministry of Health shares clinical guidance for use of cannabis-based products, guidance which was developed with external consultation.
  • Health Canada regulates prescription products and medical devices containing cannabis or cannabis-derived products under the existing drug review process.  One prescription medicine has been authorised. Additionally, individuals are able to access medicinal cannabis via other means (directly from a federally licensed seller, producing a limited amount of cannabis for their own medicinal purpose, designating someone to produce it for them).
  • To date, the US FDA approved one prescription medicinal cannabis product. The Expanded Access pathway and Right to Try avenue may provide an option for seriously-ill patients seeking to access unapproved medicinal cannabis products. Additionally, medicinal and/or recreational use of cannabis is now allowed in some states.  A public hearing was recently held by the US FDA in relation to medicinal cannabis, with a variety of stakeholders represented, including acadaemia, health care professionals, patients, government, and other stakeholders with an interest in this area. A docket for public comment remains open until 02 July, 2019.

So, how do you begin your Regulatory Strategy for Medicinal Cannabis?  Try answering the following five questions…

… and remember to fall back on some basic Regulatory Strategy principles (links to my Regulatory Strategy articles are provided below).


Five questions to help you begin your Medicinal Cannabis Regulatory Strategy…

  • What is the political state of play with regards of legalisation of cannabis use in your region(s) of interest? Though they evolve, regulations can be a point-in-time reflection of the broader landscape.
  • What is the compositional profile of the medicinal cannabis product – what proportion comprises psychoactive components (such as tetrahydrocannabinol, or THC) versus non-psychoactive components (such as cannabidiol, also known as CBD)?
  • What is the intended indication(s) and what is the current therapeutic regime in that space?
  • What are the expectations of your target federal and state (if applicable) regulators? Don’t forget to undertake a targeted on-line search for guidance documents and must-have compliance requirements.
  • What regulatory pathways might your target Regulator(s) offer, and how closely do they follow the processes and requirements for non-medicinal cannabis therapeutics?

Contact Mary for a complimentary Regulatory Strategy starter tip discussion or Regulatory Strategy assessment.

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