The Therapeutic Goods Administration (TGA) is examining whether to change the Special Access Scheme approval timeframes for medicinal cannabis prescribed to patients under 18.
At present, SAS-B applications covering category 2, 3, 4 and 5 products for paediatric patients carry a maximum approval period of 24 months.
In an update published on its website, the TGA said that timeframe is being reviewed "to determine if it is appropriate to ensure regular and continued involvement of a 'specialist' medical practitioner, in addition to a GP".
The regulator also reminded prescribers that all applications to give medicinal cannabis to children — excluding category 1 medicine — must be accompanied by a letter from a specialist issued within 12 months of the SAS-B submission.
Paediatric doctors have consistently argued that the specialist approval requirement creates delays in care for children whose conditions have not responded to conventional treatments.
German adult-use market
Germany's coalition government has confirmed it has no plans in the near term to reverse the legislation that legalised cannabis in 2024.
A further review is expected toward the end of the year, once the new framework has been assessed in practice.
The announcement that the coalition would leave the cannabis laws intact followed survey results showing most Germans opposed repealing the legislation.
Argent Biopharma
A medicinal cannabis development and manufacturing company called David Trading Ltd has entered into a binding term sheet to operate the Malta-based facility of ASX-listed Argent Biopharma.
The company, about which limited details are publicly available, will take on full operational responsibility and financial liability for the facility over a 49-year term, and holds an option to purchase it outright.
According to an ASX announcement, David Trading will bring new product lines from its own portfolio to the facility while continuing to manufacture Argent's CimetrA medicine.
Argent described David Trading Ltd as a "vertically integrated cannabis research and development company specialising in pharmaceutical-grade cannabis products and drug-delivery technologies".
The company's country of incorporation and the specific cannabis products it produces were not immediately disclosed.
Cann Compounding
Dr Kylie O'Brien, previously an executive at both Releaf Group and Cannim, has been appointed chief scientific officer of Cann Compounding and Infinity Wellness Group.
She joins the Crisci Group-owned businesses after a period at integrative medicine company Health104.
Crisci Group said O'Brien will lead R&D initiatives across the operations "focusing on evidence-based innovation in medicinal cannabis, longevity and wellness medicine".
