BREAKING NEWS: The Therapeutic Goods Administration (TGA) will be conducting another public consultation on overhauling the standards required for imported medicinal cannabis before the end of the year, with changes expected in March 2022.
TGA director of experimental products Petra Bismire told attendees at a webinar on changes to sponsor requirements for supplying unapproved medicinal cannabis products in Australia that while GMP requirements remain unchanged at present, a level playing field can be expected next year.
She said: “GMP requirements at present remain the same, but we held a public consultation in January regarding the issue and changes will be brought into place. They are expected to be effective from approximately March next year [and] 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.”
Earlier this month, Cannabiz reported fears the so-called level playing field appeared some way off, with the TGA warning the complex nature of the potential reforms had created the need for more “targeted” discussions.
The protracted nature of the process has frustrated Medicinal Cannabis Industry Australia (MCIA), which revealed it had raised the issue with TGA boss John Skerritt and was seeking talks with federal health minister Greg Hunt.
In an update posted on its website, the TGA confirmed that reforms, including GMP requirements for imported products, are “intended” to be in place next March.
But it gave no guarantee, warning that the timeframe is subject to “consultations across government, on outcomes of the Regulatory Impact Statement (RIA) and on Technical Barriers to Trade”.
The RIA is a mandatory requirement, it said, and enables an independent assessment to be carried out by the Office of Best Practice Regulation (OBBR).
“We anticipate there will be some further targeted consultation with industry participants and interest groups once the RIA process is complete,” the TGA said.
The regulator said 48 submissions had been received to the initial consultation – which kicked off almost a year ago and closed in January – and gave “broad support” to the proposal to bring imported products in line with domestic quality standards.
