Today the TGA just released a new medicinal cannabis GMP compliance guide titled “Guidance on GMP compliance for the manufacture of medicinal cannabis for supply under ‘approved access’ provisions“.
Not sure there would be any experienced GMP consultant surprised by any of the updates, as expected the TGA continues to follow convention wisdom, a medicine is a medicine irrespective of the origin, emotion, radical internet cancer curing claims. The TGA has a primary role to protect Australians and make sure we have effective and safe medicines.
The new medicinal cannabis GMP compliance guide covers the multiple laws that medicinal cannabis is subject to, including the regulation by the Department of Health via the Office of Drug Control (ODC) as well as the TGA who regulate controlled substances. The medicinal cannabis GMP compliance guide describes the pathways for approved access to medicinal cannabis as the only medicinal cannabis product currently registered on the ARTG is not marketed in Australia. The pathways are via a Special Access Scheme (SAS), Authorised prescribers or clinical trials (CTN or CTX).
The medicinal cannabis GMP compliance guide also describes the requirements for pharmacists and for clinical trials manufacture, as well as the manufacturing principles and standards for both the active pharmaceutical ingredient and the finished medicinal cannabis product. GMP does not apply to the cultivation and harvesting of cannabis plants for medicinal use. The Introduction Chapter of Part II of the Code of GMP (in particular in its page 6 Table 1) provides guidance on the process steps from where GMP is expected to be increasingly applied, depending on the API manufacturing process.
The Guidance also describes the relevant Annexes to the Code of GMP that will apply.
The document also states that From 1 November 2016, the Poisons Standard (SUSMP) schedules medicinal cannabis products (under specified conditions) as Schedule 8: controlled substance. Where these conditions are not met, cannabis products are Schedule 9: prohibited substance. There are also sections on administration and verification requirements, as well as further information on technical GMP guidance, stability and product quality reviews.
With the scheduling changes effective 1st November, the two main cannabinoids of therapeutic interest Tetrahydrocannabinol (THC, dronabinol or Δ9-tetrahydrocannabinol) and Cannabidiol (CBD) may be imported directly from TGA certified international GMP manufacturers for use in medicines (with ODC permission). Anyone making a (sunk) investment in this area should carefully consider the long term local and international competition.
The Australian Government has sole responsibility for regulating the cultivation and production aspects of cannabis for medicinal and related scientific purposes. Manufacture of, and patient access to, medicinal cannabis products is however a joint responsibility of the Australian Government and the states and territories.
Today, the ODC released an online smart form to apply for a cultivation, production or research licence relating to cannabis for medicinal purposes. This form can also be used if you are seeking a manufacture licence but ONLY if you are also applying for a cultivation and/or production licence or a research licence. If you are applying solely for a manufacturing licence, visit the manufacturers section of the website.
The TGA also released two webpages; one detailing an overview of the regulation of medicinal cannabis products (with a nice table on how the legislative requirement work together) and the other providing information on access to medicinal cannabis in Australia.
Medicinal Cannabis and Innovation Dinner
If you would like to hear more, please come along to our Medicinal Cannabis and Innovation Dinner at Melbourne Zoo on the 15th of November where Waters will give a technical talk by Waters on Supercritical Fluid Extraction (SFE) which is a technique used in the manufacture of medicinal cannabis.
We will also hear from Teresa Nicoletti, who is a lawyer from Piper Alderman. Teresa is an expert on the legalisation of medicinal cannabis. She will take us on the fascinating journey having the political will, describing the legislation on medicinal cannabis that has been passed by state and federal government and what the future holds.
You may also be interested in the following blogs:
Seed to Sale Software – the caveats and CRF Part 11 clashes
TGA GMP Manufacturing licence for medicinal cannabis
Access to medicinal cannabis clinical trails under the CTN scheme