The Therapeutic Goods Administration (TGA) has dismissed fears that recent changes to import quality standards for medicinal cannabis will lead to a shortage of medicine in Australia.
Last week, the regulator released details of reforms to TGO93, the rules governing quality, packaging and labelling requirements which go into effect on July 1, 2023.
However, fears have been raised that the changes could lead to a shortage once suppliers are forced to withdraw products which do not comply with Good Manufacturing Practice (GMP) standards.
In New Zealand, some patients were unable to source the product of their choice when the country’s new medicinal cannabis scheme came into force last year and products failed to get approved in time.
However, speaking during a webinar to explain the TGO93 reforms this week, TGA manufacturing quality branch head Jennifer Burnett insisted the regulator’s data gave it confidence there will be sufficient substitutes available for non-compliant product.
She said: “We came up with a list of equivalent GMP based on data we hold on the place of manufacture or the source of imported goods.
“We were looking to see whether there would be sufficient availability of GMP-compliant goods. ‘Are there similar regulatory approaches in other jurisdictions such that it wouldn’t be a significant impost and nor would it negatively affect supply?’
“There’s a lot of GMP product in Australia and internationally and we are confident that there are a lot of substitutes for that non-compliant product.”
However, Burnett acknowledged the new rules will have an impact.
“Inevitably we’ve got product coming in from sites that don’t have GMP. Do they want to achieve compliance? If they do, fantastic. If they don’t, then they’re choosing not to supply to Australia.
“We absolutely recognise that we will have goods that will no longer be imported into Australia. But we have been very careful to ensure that patients are not severely disadvantaged by a sudden lack of supply of their medicine.”
TGA assistant director, manufacturer assessment support section, Paul Crossley stressed that the market opportunity and rules in Europe meant many producers are already GMP compliant.
He added: “If you want to supply to the European Union you need to have GMP. That’s a lot of producers around the world.”
Meanwhile, Crossley said the TGA would “consider” what needs to be done about pharmacies inadvertently holding delta-8 THC products which breach TGO93. Last week, the regulator clarified that cannabinoids which have been chemically altered are non-compliant goods.
He said: “We have heard about the issue of delta-8 and the need to address some inadvertent [non-]compliance in the past. We’ve definitely taken that on board and will consider what needs to be done there.”
When asked by a webinar attendee why there had been no stakeholder consultation or transition period for delta-8, Crossley said nothing had changed.
“If there’s delta-8 created from hemp using a chemical process, that has not been allowed under the previous version of TGO93. We just wanted to make sure everyone understood that.
“We can’t transition from something that wasn’t allowed in the first place,” he added.