Industry bodies have welcomed suggestions from the Department of Health that it may put imported medicinal cannabis products on the same quality footing as locally-made medicine.
Cannabiz revealed last week that plans are being considered to force all overseas products destined for Australia to be manufactured to Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice standards, as local products are required to do.
The issue has long been a source of tension with the local industry which has grown increasingly frustrated at what it regards as an uneven playing field.
The Department of Health is set to propose amendments to the TGO 93 regulations ahead of a consultation period with the industry. A decision could be made in the first half of 2021.
The Australian Medicinal Cannabis Association (AMCA) said it was “cautiously optimistic” that change was coming.
“This could be the first significant step towards finally seeing fair treatment for Australian products verses imported products which currently only have to meet quality standard TGO 93, not production in a GMP-licensed facility,” an AMCA spokesperson said. “We see this as one of its priorities and look forward to participating in consultations with the Department on behalf of our members. We hope that the expected timeline of end-20 for such consultations is met.”
Medicinal Cannabis Industry Australia (MCIA) chairman Peter Crock described the move as a “good step forward”.
“Our objective at the end of the day is to support Australian companies, some of which are local producers and some of which are importing product,” he said. “The important thing is medicinal cannabis is seen as a valuable and suitable medicine. We want to work with the TGA to make sure the industry develops, through imported products as well as local products.”
The move to hold imported product to the same quality standards as locally manufactured medicinal cannabis was unexpected as it was welcome.
It came just a week after the TGA contentiously revealed that a test of 22 products found a number of imported products failed to meet required TGO 93 potency levels.
The public naming of the suppliers by the TGA riled the companies involved, and the wider industry, with claims the regulator was too hasty in publishing the data and did not follow the same processes it adopts for registered product.
It is understood the MCIA will make its dissatisfaction known to the TGA.
Bringing imported product in line with standards required for local producers is likely to help shore up quality – and confidence – in the sector, with more robust compliance monitoring by the TGA.