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Asia-Pacific Roundup: TGA seeks feedback on medicinal cannabis reforms

Posted 22 December 2020 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA seeks feedback on medicinal cannabis reforms

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on planned changes to the regulation of the manufacturing, labelling and packing of medicinal cannabis that will more closely align the requirements on imported and domestically produced medicinal cannabis.
 
Domestic producers of therapeutic goods, including medicinal cannabis, must get a good manufacturing practice (GMP) license and undergo TGA inspection. Overseas producers of most therapeutic goods typically obtain GMP clearance through desktop assessments supported by mutual recognition agreements or compliance verification processes. Overseas producers of medicinal cannabis can bypass the GMP clearance step.
 
The situation has arisen because medicinal cannabis is supplied via TGA pathways for unapproved products. A declaration that the product conforms to TGO 93, a standard for medicinal cannabis, is needed to supply unapproved products via the SAS B pathway but there is no equivalent GMP rule. 
 
TGA proposed three options to improve the quality and safety of medicinal cannabis by applying equivalent GMP rules to domestic and overseas products. One proposal would change the regulations to require imported medicinal cannabis to be manufactured with equivalent GMP. Another would build GMP requirements into the TGO 93 standard for medicinal cannabis. The third would maintain the status quo.
 
There are pros and cons to the reforms, according to the TGA consultation. Requiring equivalent GMP would align the rules on domestic and overseas products. However, that change would still permit the importation of starting material into Australia for use in the extemporaneous compounding of medicinal cannabis products. Amending TGO 93 would capture all medicinal cannabis but “practical difficulties would remain for verifying that extemporaneously compounded medicinal cannabis products complies with TGO 93.”
 
To address the situation, TGA proposes to either ban the compounding of medicinal cannabis or require pharmacists and healthcare professionals to have a GMP license to compound medicinal cannabis.
 
The consultation also addresses potential labelling changes and the reporting of heavy metal results — reflecting TGA’s concerns about the lack of consistent rules — and the need for child-resistant closures on medicinal cannabis products. Most medicinal cannabis products checked by TGA already have child-resistant closures, but the agency is considering enforcing the requirement through changes including TGO 93 edits and the extension of TGO 95.
 
TGA is accepting feedback via its Consultation Hub until 29 January.
 
TGA Notice
 
TGA details progress in improving post-market medical device oversight
 
TGA has shared details of the postmarket medical device monitoring changes it has made to address public concerns about how it identifies and assesses potential safety problems.
 
While TGA is working on six key outcomes, the update focuses on effort to improve consumer- and patient-facing information. The update details the creation of sections of TGA’s website that collate information about devices of concern, such as surgical mesh, and the establishment of patient implant cards for higher-risk products.
 
The reforms were made in parallel with a push for more consumer consultation. The agency now has consumer working groups for specific medical device issues that work alongside its existing partnerships with state and territory health departments and the Australian Commission on Safety and Quality in Health Care.
 
Reforms are ongoing. TGA highlighted improvements to the searching, sorting and downloading functions in the Database of Adverse Event Notifications as in progress. The changes are intended to allow stakeholders to assess the data and generate summary reports covering devices of concern.
 
TGA Notice
 
Pakistan posts draft guidelines on human stem cell R&D
 
The Drug Regulatory Authority of Pakistan has released draft guidelines identifying the “urgent need” for stem cell regulations that ensure the use of human cells and tissues upholds human dignity and complies with social and Islamic values. The guidelines, which were published on December 14, are open for comment for 15 days.
 
The guidelines address a mix of scientific, ethical and legal considerations. They cite the impact of the source material, culturing procedures, surface markers and other parameters on the properties of stem cells to make the scientific case for regulating the field. Authorities in Pakistan want to regulate those details and other aspects of R&D and production to mitigate risks associated with the use of stem cells.
 
Other aspects of the guidelines address the ethical and legal implications of working with human stem cells. The guidelines state researchers must inform donors of all details related to the use of their stem cells, including the potential for their materials to be used in cell lines that are shared with teams in Pakistan and overseas. Donors have no intellectual property rights if their donated materials are genetically manipulated to create products with commercial value.
 
 
Draft Guidelines
 
Japan asks ventilator manufacturers to self-inspect devices after safety incident
 
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has asked ventilator manufacturers to self-inspect their products following a safety incident related to the failure of a device to trigger a required alarm.
 
The incident occurred when a third-party component was used with a ventilator. A leak occurred due to a disconnection involving the component. However, the ventilator failed to trigger an alarm to alert the users of the leak. While the incident involved a component not designated for use with the ventilator, PMDA thinks such use of third-party products could happen again in clinical practice.
 
Considering that prospect, PMDA has asked marketing authorization holders to assess if their products may fail to trigger an alarm when used in combination with “products that are highly likely to be connected with them.” Companies that discover such shortcomings should promptly inform users.
 
PMDA also asked companies to assess their package insert statements about audio alarms by the end of January.
 
PMDA Notice
 
TGA makes e-cigarettes prescription only, permits OTC cannabidiol sales
 
TGA is set to make nicotine e-cigarettes prescription-only products in October 2021. The Australian agency disclosed the change days after revealing low-dose cannabidiol is being down-scheduled to enable over the counter (OTC) sales.
 
The change in the regulation of e-cigarettes will align national and local rules. Australian states and territories already prohibit the supply of e-cigarettes that contain nicotine without a prescription.  Yet, the lack of a comparable national ruling has allowed people to import nicotine e-cigarettes without a prescription.
 
TGA plans to hold a public consultation on the safety and quality of e-cigarettes in February. Planned changes include the mandating of child-resistant closures for liquid nicotine to reduce the risk of ingestion.
 
Separately, TGA has decided to down-schedule low-dose cannabidiol. The change will end the need for patients to have a prescription to access the product. Instead, the product will be available OTC at pharmacies.
 
TGA Notice, More

 

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