The TGA recently held webinars about reforms that impact the medicinal cannabis industry, including:
- Changes to prescribing medicinal cannabis through the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways
- The removal of TGO 93 Standard for Medicinal Cannabis declaration requirements
- Their intent to increase random and targeted quality testing of medicinal cannabis products in Australian supply.
Summary of Changes to SAS and AP applications
Volatility in the cannabis industry has led to stock shortages, product name changes, and discontinuations. To make life easier, the TGA has determined that SAS and AP applications for unapproved medicinal cannabis products will no longer be tied to trade/brand names. Instead, applications are now allowed for different categories of active ingredient.
This new categorisation is framed around CBD and THC percentages, with the intention of allowing flexibility for products that may contain other cannabinoids in the future.
The categories are as follows
- Category 1 – CBD ≥98%
- Category 2 – CBD ≥60% and <98%
- Category 3 – CBD <60% and ≥40%
- Category 4 – THC 60-98%
- Category 5 – THC >98%
Products in categories 1, 2 and 3 have also been included in the Authorised Prescriber ‘Established history of use’ listing (specifically for refractory chronic pain and refractory anxiety), meaning a Human Research Ethics Committee (HREC) or medical specialist college endorsement will no longer be required prior to approval of an AP request. According to the TGA, this ‘established use’ category will cover a large portion of the SAS Category B application pathway submissions received thus far and streamline applications through the AP system.
This approach allows:
- a reduction in the administrative burden for prescribers who determine that an unapproved medicinal cannabis product is clinically suitable for their patient.
- prescribers to obtain approval for a product category without having to apply to the TGA every time for a new product.
- flexibility in brand substitution when needed, i.e. in the event of product shortage or discontinuation.
- improved patient access by enabling continuation of therapy.
- Prescriptions must still be specific regarding the dosage form and indication (an AP may still specify brand in a prescription if they deem it appropriate).
- Medicinal cannabis obtained through SAS or AP remains an unapproved medicine (i.e. that have not been evaluated by the TGA for safety and efficacy) and any liability still lies with the prescriber.
- Current SAS/AP permissions still apply until their expiry but will be restricted to the initial brands. Medical practitioners will need to reapply for permission to prescribe the generic categories.
- For compounding, SAS approval from a medical practitioner must be received before compounding can take place, however both domestic and imported medicinal cannabis may be used.
Changes for sponsors
Changes for sponsors are more straight forward.
Sponsors of unapproved medicinal cannabis products are no longer required to submit a declaration of conformity with the TGO 93 testing standard. However, sponsors must ensure that products continue to meet TGO 93, as well as all other relevant legislative requirements (e.g. TGO 100 for microbiological testing).
NOTE: This also applies to investigational medicinal products that are being used under a clinical trial scheme.
Alongside this, the TGA also intends to increase the number of random and targeted audits, as well as increase testing of medicinal cannabis products imported or supplied in Australia. Testing will focus on consistency of claims of cannabinoids (which the industry has been in trouble for before) plus toxins and contaminants.
Non-compliance will mean sponsors will be subject to regulatory actions under section 14 and 14A of the Therapeutic Goods Act, 1989.
The TGA also confirmed during the webinar that sponsors must receive AP/SAS letter before releasing goods for supply, i.e. they cannot provide products to pharmacies unless there is evidence that supply is proceeding under one of the approved schemes. I have discussed wholesale restrictions and direct control requirements in a previous blog.
Updated reporting requirements
While HREC involvement is not required prior to prescription, APs must report numbers of patients treated every 6 months.
Sponsors must also make a similar report every 6 months (of patients supplied under different access schemes) using the following proforma:
In March, 2022, the TGA intends to introduce Good Manufacturing Practice (GMP) requirements for imported medicinal cannabis products, equivalent to those that already apply to goods manufactured domestically. This has been a contentious point for a while between the local industry and regulators, and is sure to level the playing field for domestic manufacturers vs importers.
There will also be new labelling and packaging requirements introduced for manufacturers (including child-resistant closures and clearer label statements to identify the active ingredients). (Unapproved medicines are generally exempt from the normal labelling requirements under section 5 (b) of TGO 91/section 12A of the Therapeutic Goods Regulations 1990.)
If you found this content useful, and would like develop your systems further, PharmOut sells a Pharmacovigilance template pack to help you get started on your monitoring journey. You can also get in contact to schedule a chat with one of our experienced consultants.
If you found this blog useful, you may also be interested in the ones below: