The Therapeutic Goods Administration (TGA) is reviewing the Special Access Scheme timeframes around the approval of medicinal cannabis for under 18s.
Currently, SAS-B applications for category 2, 3, 4 and 5 products for paediatric patients are approved for a maximum period of 24 months.
In an update to its website, the TGA said that timeframe is under review “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 doctors that all applications to prescribe medicinal cannabis to children, with the exception of category 1 medicine, must be supported by a letter from a specialist dated within 12 months of the SAS-B submission.
Doctors specialising in paediatric care have long argued that requiring specialist approval delays care for children for whom conventional drugs have failed to work.
German adult-use market
Germany’s coalition government has confirmed it has no immediate plans to roll back the laws which legalised cannabis in 2024.
However, it is understood a further assessment will be made at the back end of the year once the new framework has been reviewed.
News that the coalition will make no change to cannabis legalisation followed a poll which found a majority of Germans did not want the law to be repealed.
Argent Biopharma
A company specialising in the development and manufacture of medicinal cannabis, David Trading Ltd, has signed a binding term sheet to run the Malta-based facility of ASX-listed Argent Biopharma.
The company, of which little is known, will assume full responsibility and financial liability for operating the facility for the next 49 years. It also has an option to acquire the facility.
David Trading will introduce new product lines from its own portfolio, in addition to continuing to manufacture Argent’s CimetrA medicine, an announcement to the ASX said.
Argent described David Trading Ltd as a “vertically integrated cannabis research and development company specialising in pharmaceutical-grade cannabis products and drug-delivery technologies”.
It was not immediately clear where the firm is based or what cannabis products it manufactures.
Cann Compounding
Former Releaf Group and Cannim executive Dr Kylie O’Brien has been named chief scientific officer for Cann Compounding and Infinity Wellness Group.
She joins the Crisci Group-owned businesses following a brief spell at integrative medicine firm, 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”.