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- Presented by: Petra Bismire, Therapeutic Goods Administration
- Presented at: Online webinar
- Presentation date: Monday 22 November 2021
- Presentation summary: Guiding you through your requirements as a sponsor of an unapproved medicinal cannabis product.
- Presentation: Medicinal cannabis - Changes to sponsor requirements for supplying unapproved medicinal cannabis products in Australia (pdf,1.38Mb)
Recording of online webinar presentation
I'd like to start by acknowledging the traditional owners of the lands on which we're meeting today here in Canberra, that's the Ngunnawal people. But I'd like to acknowledge that we're meeting across a large number of lands today and I'd like to pay my respects to elders past, present and emerging across all of those lands. And I'd like to extend that acknowledgement and respect to any Aboriginal or Torres Strait Islander peoples that we have here today.
I'll start by introducing myself. My name's Petra Bismire. I'm the director of the experimental products section here at the TGA. We look after access to unapproved therapeutic goods, that includes medicines, biologicals and medical devices. And that's namely via the Special Access Scheme and the Authorised Prescriber Scheme.
In today's session, I'll be talking through your obligations as a sponsor to help you understand the changes in sponsor requirements when supplying an unapproved medicinal cannabis product under the unapproved patient access schemes in Australia. We'll be covering the removal of the TGO 93 declaration form, the introduction of a new sponsor six-monthly reporting form, which streamlines the existing reporting obligations and how the move to SAS and AP applications by active ingredient will affect you as a sponsor.
I'll move through the presentation and then I'll allow some time at the end of today's presentation for questions. There's some pre-submitted questions that we'll address and then we'll move on to the live questions. I'll start with the removal of the TGO 93 declaration form. As of today, we've removed the requirement for sponsors to submit a declaration of conformity with the TGO 93 for every product. It's important to note that you're still required by law to ensure that your products comply with the TGO 93. However, the declaration form is no longer required. As you're aware, unapproved medicinal cannabis products imported into or supplied or manufactured in Australia must conform with therapeutic goods standard for medicinal cannabis, order number 93, which we refer to as the TGO 93. This order specifies the minimum quality requirements for medicinal cannabis products.
And we've removed the requirement for the declaration form, following an internal review designed to reduce regulatory burden for industry and administrative burden for prescribers. And to allow TGA approvals by active ingredient. It's important to note that your responsibilities to comply with the TGO 93 haven't changed.
Sorry, I'll move the slides along. Might help you. It's important to note that your responsibilities haven't changed. And you remain legally responsible for your products conforming with the TGO number 93, as well as other applicable orders, including the TGO 100, which is the microbiological standard for medicines. And as you're aware, it's an offence under the act to import, export or supply therapeutic goods that do not conform with an applicable standard.
And breaches are subject to a range of compliance actions, including civil and criminal penalties under the act, under the Therapeutic Goods Act. Up here, I've got some guidance documents that are included on the TGA website. They'll provide you with additional guidance for complying with therapeutic goods orders, such as TGO 93 and TGO 100. I've had notification that I can't be heard. Is it that I can't be heard clearly or can't be heard at all?
Thanks for the feedback. Sounds like most people are able to hear clearly. That's good to know. I'll move on to ongoing targeted testing. As you're aware, rather than collecting TGO 93 forms, we'll instead be diverting resources to expand our TGO 93 compliance programmes. We'll be continuing our audits, which include laboratory testing. And this includes, but isn't limited to, consistency with claims of the stated content of active ingredients, as well as analysis of toxins and impurities in these medicines.
And we'll be doing this testing on a random basis, as well as targeted testing. You're also reminded that your goods must comply with the Therapeutic Goods Advertising Code so that all material with information about the goods, that includes the label, must be truthful, balanced and not misleading. And otherwise, promote safe and proper use. I'll move on now to sponsor-reporting obligations under regulation 47B of the therapeutic goods regulations.
We've developed a new six-monthly reporting form to streamline this requirement, but it's important to note that this is an existing requirement. We've introduced a new form that will help make this reporting easier for you. Under this form, sponsors must detail the product supplied, including the trade name and the quantity supplied in Australia by the sponsor under each access pathway during the period to which the report relates. I've included the form itself. And you can see here that you must record the active ingredients, the trade name of the product. In the case of medicinal cannabis products, unapproved sponsors of medicinal cannabis products must record the category of cannabinoid content. And we'll cover that next. But there is a footnote here, a key with details of those categories. The quantity that you supplied in the six-month period and under which pathway you supplied that good.
The reporting periods are from January to June and from July to December, inclusive. And reports must be submitted within one month of the end of the reporting period. And it's important to note that this isn't a new requirement. This is an existing requirement. The current six-month period that we're in will end in December and you'll be required to submit reports of your usage by the end of January.
The six-monthly reporting forms will be used to inform the names of products on the TGA website that I'll be taking you through later. It's important that these reports are submitted in a timely fashion in order that product names can be included on the TGA website. As I mentioned, we'll be publishing on the TGA website medicinal cannabis product details by active ingredient categories. And the idea of the publishing of this information is to support healthcare professionals in prescribing and supplying medicinal cannabis products.
I'll go through that in a moment. But firstly, I just wanted to touch on the reporting of side effects. The TGA has an important role in monitoring the safety of unapproved medicines. We investigate significant safety concerns as a part of ensuring product safety in the Australian community. And there's multiple ways in which you can report adverse events and defects. And further information is available on the TGA website.
But our preferred reporting route is via the online portal and the link is included here. Adverse events or defects associated with the use of a medicine must be reported to the TGA within 15 calendar days. I'll move on to decision to move SAS and Authorised Prescriber applications away from trade name and to applications by active ingredient. These changes have been made to reduce the administrative burden for prescribers.
As we're finding prescribers had to reapply for new product-specific TGA approvals very frequently due to stock shortages and discontinuations, as well as name changes. As you're aware, a change to the name of a product renders that product separate and distinct under the act and a new approval would be needed. The move to prescribing by active ingredient provides prescribers with greater flexibility in what they choose to write on their prescriptions.
This will reduce administrative burden for prescribers as they'll no longer require a separate approval for their patient for a specific branded product if that's suddenly discontinued or is in shortage. Approvals will no longer be granted for a specific product or brand. However, we recognise the complexity of the cannabinoid content of medicinal cannabis products and we've decided to allow submissions on the basis of broad category of cannabinoid content.
And we've developed five broad categories that I'll be going through. This change essentially means that prescribers would obtain approval for a category and then issue prescriptions for any products that they like that falls within that category. And that just means that they don't need to reapply to the TGA for approval every time. Importantly, the approvals will remain specific to dosage form and indication. And ultimately, these changes are expected to improve patient access for appropriate patients.
Next, I'll take you through the five active ingredient categories that have been developed. And hopefully, you can see that clearly on your screen here. But we have five medicinal cannabis categories. Sorry. And we've framed these categories around the content of cannabidiol in the product and you can see that in the column there on your right. Category 1 products, these products meet the Schedule 4 prescription only definition as laid out in the Poisons Standard or the SUSMP.
And for these products, cannabidiol comprises 98% or more of the total cannabinoid content of the medicine. And the remaining 2% can be made up of other cannabinoids and that may include THC. And importantly, the medicine must contain no other active ingredients. For Category 2 medicinal cannabis products, we're calling CBD-dominant medicinal cannabis products. And you can see here that Category 2 products are made up of between 60% and 98% cannabidiol, with the remainder being made up of other cannabinoids.
It's important to note that we have framed the categories around the content of cannabidiol because that's the lower risk cannabinoid. This means that there's flexibility for products which are dominant in a cannabinoid other than THC or CBD. With these next products, although we've named them according to THC content, because we acknowledge that THC is likely to be the most dominant cannabinoid other than cannabidiol.
That does allow flexibility for products which are dominant in other cannabinoids to be captured under these categories. Category 3 is what we're calling balanced medicinal cannabis products. And essentially, they contain around 50/50 CBD and THC in general, but it could be other cannabinoids as well. As you can see from the definition here, these products are comprised of between 40 and 60% cannabidiol, with the remaining cannabinoid content being made up of other products, which may include THC.
Category 4 products, we're calling it THC-dominant medicinal cannabis products. But again, they could be dominant in other cannabinoids. The key thing here is that cannabidiol makes up between 2 and 40% of the cannabinoid content. And the remainder can be made up of other cannabinoids. And Category 5 products, which we're naming THC medicinal cannabis products, are made up of between 2% and 0% CBD.
And we acknowledge that some of those may be pure THC. I hope that that clarifies the categories. I thought I'd provide an example of what a TGA approval letter will look like under these changes that are effective from today. An Authorised Prescriber letter, for example, will just have the Category 1 CBD medicinal cannabis products and for the indication refractory anxiety in adult patients.
A SAS product, again, we'll just include the category. And doctors will gain TGA approval for this category, but doctors can include more detail on their prescription. For example, they will need to include details of the active ingredient, dosage form. Where clinically appropriate, they may wish to include the brand name. But these changes simply mean that a new TGA approval letter is not needed every time. And this is in line with all other unapproved medicines for which we don't have a brand name.
As I mentioned, we'll also be publishing a list of medicinal cannabis products by category on the TGA website. And that's in recognition of the complexity of the cannabinoid content and the difficulty that prescribers and pharmacists may run into. We'll be publishing a list of medicinal cannabis products by trade name according to the active ingredient categories on the TGA website. The list is likely to go up this afternoon or tomorrow.
But it's currently under review to ensure the product names are compliant with legislation. There's been a delay on the uploading of those particular product names. And we'll also be making sponsor details available to facilitate patient access. In terms of further support, we've updated all of our webpages on the medicinal cannabis hub. If you're familiar with the TGA webpage, you'll be able to go to the medicinal cannabis hub.
Or otherwise, you can just search medicinal cannabis in the TGA webpage, find the medicinal cannabis hub. And there's a special page for sponsors and manufacturers. We've also created a number of support tools. That's the description of the active ingredients. The links are included here, a list of medicinal cannabis products by category of active ingredient and also the Authorised Prescriber Scheme list of medicines with an established history of use.
It may not be particularly relevant to sponsors. But in the healthcare professional webinars that I've been delivering, I've been explaining the addition of Category 1, 2 and 3 medicinal cannabis products for specific indications in the Authorised Prescriber list of medicines with an established history of use. And these particular products, prescribed as medical practitioners only, can apply to become authorised prescribers of these particular products by category, dosage form and by indication, where it's included on that list.
Without the need to obtain ethics committee approval prior to applying to the TGA. We've also updated our guidance documents. That's the Authorised Prescriber guidance document, the SAS online system guidance document and the Authorised Prescriber online system document. And we'll be making the slides from this webinar available after the presentation finishes. I'll move on now. There's been some questions pre-submitted prior to the webinar that we can answer.
And then once we're finished with those, we'll be moving into the live questions. As I mentioned, there was an opportunity to submit questions prior to the webinar. We'll start with answering a few of those and then we'll move into the live questions.
We've got a question here about wholesaling. Has there been any changes to wholesaling of medicinal cannabis products?
No. Wholesaling of unapproved finished medicinal cannabis products remains prohibited. However, there is scope within the regulatory framework for sponsors to enter into distribution arrangements with third parties to assist them with supplying finished medicinal cannabis products. This means that if you're a sponsor and you import or manufacture finished products that are not entered in ARTG, you can only supply those products if they are held under your direct control.
Until they're supplied under an approved pathway to an authorised prescriber or under the Special Access Scheme to the approval holder. You also have to comply with certain conditions that are specified in the regulations. It's important to note that we've published updated guidance about what the direct control requirement means in practice. And the reason that requirement is imposed under our legislation is to make sure that the sponsor remains responsible for product control and supply decisions throughout the supply chain.
And this is necessary because we're dealing with unapproved therapeutic goods. And the role of the TGA is to manage the risks of unlawful supply to ensure necessary public health alerts and recalls are managed appropriately.
We've got a question about clinical trials. As a clinical trial sponsor using TGO 93-compliant products in our CTN, what are the changes going forward when an IMP, that's investigational medicinal product, is declared as TGO 93-compliant? And how do we know this?
Thanks, Sukainah [?]. We're amending the CTN portal so that it no longer requests clinical trial sponsors to submit a TGO 93 declaration form. And instead, an alert will be shown requesting acknowledgement of a sponsor's legal responsibilities in ensuring that the product complies with the TGO 93 and all other relevant orders. When an IMP or an investigational medicinal product changes, update in submission of the TGO 93 declaration associated with the CTN won't be required.
However, sponsors are required to update the online CTN form with the new IMP and to ensure that the new IMP complies with TGO 93, as well as all other relevant orders.
I've got a question about testing. Will the TGA look towards testing all Australian cannabis products?
A large number of medicinal cannabis products will be selected for targeted laboratory testing, as well as random testing. And other compliance assessment activities will be undertaken as part of our TGO 93 audits. As I mentioned in the presentation, this includes testing for consistency with claims of the stated content of active cannabinoid content, as well as for the presence of toxins and impurities.
There's a few questions in regards to approvals prior to the current changes. Will approvals granted under the current scheme prior to November 22nd allow medicine substitution or will a new script or approval be required?
Medicinal cannabis SAS and AP approvals that were granted prior to today will still remain valid for the duration of the approval period that's specified on the approval letter. But they'll be relevant only to that particular brand, as has been the case until today. If a prescriber wants to get an approval letter under the SAS or AP for generic prescribing under the categories, then they'll need to apply to the TGA for that approval.
Next question. How are quality standards going to be enforced under the new requirements?
The sponsors of medicinal cannabis products, as we outlined in the presentation, continue to be legally responsible for ensuring that their products comply with the TGO 93 and other relevant orders. You're just no longer required to submit the declaration of compliance. As I've mentioned many times, we'll be continuing our programme of targeted laboratory testing and other compliance assessment. And we'll be diverting resources from the receipt and entering of the TGO 93 declaration forms to the laboratories to expand our testing programmes.
I can see a few questions coming through about GMP. We've got a question here about, what about ensuring products are manufactured under GMP and that stability studies are done to confirm shelf life?
GMP requirements at present for medicinal cannabis products remain the same. But as you'd be aware, we held a public consultation in January of this year regarding this issue and changes will be brought into place. And they're expected to be effective from approximately March next year. That will level the playing field to require GMP for imported products. There's also going to be another public consultation later this year to outline further detail.
I've just gone to the live chat and got a question here about TGO 93. If TGO 93 isn't required, how do we get new products not on the new cat. system, so doctors can apply for AP or SAS B? I'm guessing this is in regards to the published list.
In regards to the Authorised Prescriber established history of use list, this is a list of particular products that have been deemed to be of established history of use in Australia and haven't had any major safety concerns in the last three years. And this is an internal review and sponsors can't apply to have particular products included on this list. This is purely an internal review. And it's done on the basis, largely of quantity, in order to reduce the burden of SAS B applications.
We do routine reviews every, approximately, 12 months. And we update many products. We include many products on this established history of use list. And in this round of updates, we've included Categories 1 and 2 for oral liquids and capsules for the indications chronic pain and anxiety. And Category 3 products has been included for oral liquids and capsules for the indication of chronic pain. And there's further information on this pathway available for prescribers on our website.
I've got a question here about release of products from the sponsor. How does a sponsor release product to a pharmacy without a product-specific SAS?
Sorry? The question is, how does it…?
Yes. I guess it's in terms of, how does the sponsor verify which product they're releasing? And this depends, I guess, on the prescription [overtalking].
That's right. The doctor will outline further detail about what product they wish to prescribe on a prescription. The changes that we're introducing from today simply cut administrative burden for prescribers. It means that they don't have to come back to the TGA every time and tell us what brand they wish to use. Instead, they can put that information on the prescription, including, for example, they may wish to prescribe cannabidiol ten-milligramme per mil and THC ten-milligramme per mil product.
And that that particular doctor may or may not wish to, if they believe it's clinically suitable, include details such as what particular brand they wish to prescribe. And a pharmacist can choose to substitute different brands, provided that that's done in accordance with normal practice and where necessary, with consultation with the prescriber.
For example, a pharmacist may wish to consult with a prescriber if a prescription is not clear.
And then they may request a new prescription. But the key thing is that they won't then need to go back to the TGA to issue a new approval.
I've got a question here about, if a doctor is an authorised prescriber under TGA, do they need to get New South Wales authority to prescribe for a compounded product?
Medicinal cannabis products may, in some states and territories, require additional authorisation or approval, as you're aware. But we believe it's the requirement to understand the legislation in the state that they're operating in, it's up to that prescriber. And the TGA can't comment on the particular jurisdictional requirements across the different states and territories.
The prescriber is encouraged to, if they have any questions about their legal requirements within their state of territorial practice, to contact their relevant state or territory health department. And we've included contact details for those states and territories on our website. When it comes to extemporaneous compounding, again, there's no changes at this stage. But this was a question that was raised during the public consultation earlier this year.
And we are looking to introduce a requirement for products which are extemporaneously compounded to require approval under SAS or AP. And again, these changes are likely to come in next year.
I've got a question here about the published list on the website of medicinal cannabis products. Is it mandatory to complete the form for publication of product details on the TGA website for unapproved medicinal cannabis products?
The form that was sent around to all sponsors is not mandatory. However, future updates will be done on the basis of sponsors' six-monthly reporting forms. And those are the report forms that are required under regulation 47B of our regulations. And that is a mandatory requirement. Sponsors must submit to us, every six months, the names and quantities of products supplied and under which pathway.
We'll be receiving those forms and we'll be using data from those forms to keep the list of products up to date. We were hoping to have that list available on the website already, but that's going to be going up later today or tomorrow. We just need to review the product names to ensure that they're compliant with legislation.
We've got a great question here about the changes and how they'll be reflected on the TGA portal. Will the TGA portal be updated to reflect changes in relation to these products?
Yes. We have updated the available options that prescribers can choose from in the SAS and Authorised Prescriber online system. The product-specific or brand-specific trade names have been removed. And instead, approvals will be granted by category. And some prescribers will choose from one of the five categories of medicinal cannabis when they're processing their applications.
I've got a question regarding documentation. Does a sponsor have to have a copy of the SAS B or AP approval prior to supply?
Yes. Under Schedule 5 of our regulations, sponsors must not release unapproved goods from their direct control until those goods are subject to a SAS or AP approval or authorisation. There's no changes to these arrangements. Sponsors must hold unapproved goods under their direct control until you're satisfied that you've seen evidence of approval on the SAS or Authorised Prescriber to release those goods.
We've got a question here about SAS B and AP approval durations. How long does a TGA SAS B approval last for for a patient under the new changes?
There's no changes to the approval duration for SAS B applications. And those are typically approved for 24 months. However, as always, the delegate has discretion to amend that. But typically, 24 months approval. For Authorised Prescriber applications under the streamlined pathway, that's Categories 1, 2 and 3 for chronic pain and for anxiety for Categories 1 and 2, no ethics committee approval is required.
And typically, approvals will be granted for five years. Again, that's open to delegate discretion. But typically, every five years. However, authorised prescribers are instead required to submit to us the patient usage every six months. And the reporting periods are the same as for the regulation 47B sponsor reporting. Those periods are January to June and July to December. And forms must be submitted within one month of the reporting period finishing.
We've got a question here about codes. Do the categories have specific codes? And if so, what are these?
Yes, they do. The categories and codes are included, both on the Authorised Prescriber application form and on the Authorised Prescriber established history of use list. And this information has been made available on the TGA website in all our guidance documents. And I've been outlining it for prescribers in our webinars.
But as a sponsor, when it comes to recording which pathway you've supplied your goods under for your six-monthly reporting forms, it doesn't matter whether the product is coming under standard AP pathway, Authorised Prescriber pathway, which requires ethics committee approval. Or whether that prescription has come in under the streamlined pathway. But you will be required to differentiate whether you've supplied products under the Authorised Prescriber pathway or the SAS pathway.
And sponsors can know which pathway those came under, obviously, on the basis of the approval letters. Also, still getting quite a few questions coming through regarding pharmacists' substitution generic prescribing. Essentially, a pharmacist would be empowered to do generic substitution as per normal dispensing practice. And prescribing or prescriptions come under the remit of states and territories. The TGA will provide approval under category, under a category of cannabinoid content.
And then the doctor is required to provide as much detail as they think the pharmacist needs in order to issue a prescription. For example, they may prescribe a product which is ten milligrammes per mil of THC and 12 milligrammes per mil of CBD. As long as that prescriber also holds an approval for a Category 3-balanced product, the TGA doesn't get involved then in what particular product would be dispensed.
That's a matter for the pharmacist and the doctor to describe. And that's no different from normal practice. If the pharmacist felt that there wasn't enough information on the script, then they would contact the doctor to ask for further information. If a particular brand was out of stock, they may call the prescriber and they may wish to ask for a new prescription if that was necessary. Or they may interchange that product if it's appropriate.
When it comes to prescribing and prescriptions, these fall into the remit of state and territory legislation and pharmacists and medical practitioners requirements under the relevant boards of practice. These are simply prescription medicines and they should be treated no differently to other prescription medicines, with the exception of the requirement for unapproved medicines to have a SAS or AP approval in place.
The question here, another question's come through, how does the sponsor know if the pharmacist switches brand? You'll know if your product has left your warehouse and you should know under which scheme that has left the warehouse. Then you'll be able to provide that information on your sponsor report. On this question here on side effects reporting, both sponsors and prescribers have responsibilities to report side effects.
And our preferred reporting route for that is via the online portal. And thanks everyone for attending this afternoon. If you do have any further questions, if we haven't answered any questions that you had today, please do email us on firstname.lastname@example.org and we'll address those questions as best we can. Thanks again for joining us this afternoon.