Asia-Pacific Roundup: TGA changes medicinal cannabis approval process, plans further reforms

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| 23 November 2021 | By Nick Paul Taylor 

The Therapeutic Goods Administration (TGA) has revised the process for applying to supply medicinal cannabis products under Australia’s Special Access Scheme (SAS) and Authorised Prescriber scheme. TGA made the changes after holding a consultation that also convinced it of the need for other, more substantive reforms of the approval process.
 
In the first set of changes, which took effect on Monday, TGA dropped the need to file Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 declaration forms to seek approval to supply the products. While TGA has ended the requirement to submit a declaration of conformity, it still expects medicinal cannabis products to meet the requirements set out in TGO 93 and all other relevant legislative requirements.
 
Sponsors remain legally responsible for compliance with TGO 93 and may face compliance actions, including civil or criminal penalties, if they break the rules. TGA is also still requiring sponsors to file a report every six months, although it has sought to “simplify this requirement” by providing a form for them to complete.
 
The form is part of a broader effort to “reduce administrative burden for prescribers and industry and further improve patient access to medicinal cannabis.” TGA is now accepting SAS and Authorised Prescriber submissions for medicinal cannabis products by active ingredient, such as “CBD medicinal cannabis product,” rather than by trade name.
 
Officials implemented the changes after reviewing 48 responses to a consultation on topics such as good manufacturing practices (GMPs) for medicinal cannabis that began late last year. The consultation revealed “broad support for measures designed to ensure uniformity of GMP requirements regardless of the place of manufacture,” TGA said, as well as “general support for measures to reform labeling and packaging requirements for medicinal cannabis products, including mandatory child-resistant closures.”
 
In the consultation, TGA proposed requiring equivalent GMP for domestic and imported medicinal cannabis, thereby ending the current situation that allows importers to obtain permits without showing compliance with the manufacturing principles or equivalent GMP. The agency also put forward multiple options for how to mandate the use of child-resistant closures.  
 
TGA is now working to act on the feedback. The agency described the multiple steps it needs to work through to make significant reforms, from identifying the “most appropriate mechanism to implement agreed changes” to approving regulatory amendments and registering new legislative instruments. The agency aims to put the reforms, including GMP requirements for imported products, in place by March 2022.
 
Work is also underway to address concerns about extemporaneous compounding of medicinal cannabis. TGA discussed compounding in its consultation document, leading to feedback that has persuaded it to develop a mechanism to require an SAS approval from a medical practitioner before compounding can take place.
 
TGA Notice, Consultation Feedback, Guidance
 
Pakistan adopts rules on ethical marketing to healthcare professionals
 
Pakistan has enacted legislation on ethical marketing to healthcare professionals. The act is designed to encourage transparent interactions between marketeers and healthcare professionals to ensure that all medical decisions are in the best interests of patients.
 
Officials published a Code for Ethical Marketing in 2017, but there is evidence it had little immediate impact on the situation on the ground in Pakistan. A survey of industry and healthcare professionals run in 2018 found “no real time implementation is perceptible at public or private health care facilities,” adding that the researchers saw “aggressive promotion” that “can jeopardize professional ethics and may influence or impel the prescriber to prescribe irrational medication.”
 
In theory, people who broke the rules in place in 2018 could face fines and prison sentences of up to five years. However, the authors of the 2021 paper on the survey results found no evidence of the law being enforced, potentially because senior executives, not government officials, are in charge of ensuring compliance with the code of ethics.
 
The new legislation retains the structure and most of the content of the code published in 2017, but Pakistani officials have strengthened the wording in some key areas. Notably, the new legislation has a clearer position on the provision of gifts and entertainment and puts more restrictions on what can be discussed at business meetings.
 
Under the new legislation, “Companies shall not provide gifts to individual beneficiary healthcare professionals in any shape whatsoever.” The section on business meetings now states the discussion at such events must be limited to “therapeutic risk and benefit, pharmaco-kinetic or pharmaco-dynamic features and other related information supported with valid scientific data or evidence.”
 
Final Legislation
 
TGA answers questions on consent for noncompliant medical devices
 
TGA has answered frequently asked questions on applying for consent for noncompliant medical devices. The agency published the guide ahead of regulatory changes that are set to take effect on 1 December.
 
As of the start of next month, sponsors will need TGA-approved consent applications to supply noncompliant medical devices. It could already be too late for some companies to meet the timeline. TGA, in a document dated 22 November, recommended that sponsors file applications by 20 November to “allow for the standard finance processing timelines and to accommodate for the large number of anticipated invoices being requested.”
 
The rest of the document addresses details of the process, explaining that authorities will typically give consent for up to two years and that TGA will use a risk-based approach “to audit a selection of implementation plans during the consent period to verify that they meet requirements and are being appropriately applied.”
 
TGA FAQ
 
Australian device reforms spur flurry of updates on TGA reclassification
 
TGA has updated four guidance documents on the reclassification of different types of medical devices ahead of the 25 November switch to the new regulatory requirements.
 
The agency published the first versions of the guidance documents earlier this year to help sponsors and manufacturers transition to the new classification system and comply with the revised regulatory requirements.
 
TGA has left most of the text unchanged from the earlier guidance documents while making small but notable revisions such as the removal of mandatory audit assessments as a requirement for the reclassification of medical devices that are substances introduced via a body orifice. The requirement for mandatory audit assessments still applies to spinal implants and devices that come into direct contact with tissues including the heart.
 
Spinal Implants, Body Orifice, Inhaled Biologicals, Direct Contact
 
TGA grants provisional determination to Medigen’s COVID-19 vaccine
 
TGA has granted provisional determination to Grand Pacific CRO in relation to a COVID-19 protein-based subunit vaccine. Grand Pacific is acting on behalf of Medigen Vaccine Biologics.
 
Medigen is a Taiwan-based company that has received emergency use authorization for a COVID-19 vaccine in its home market. The vaccine, MVC COVID-19, was cleared for use in Taiwan despite the company lacking Phase 3 efficacy data. Medigen received clearance to run a Phase 3 study around the same time as the vaccine was authorized for emergency use in Taiwan.
 
The provisional determination from TGA positions Grand Pacific to apply for provisional registration of the vaccine in Australia. The process will provide a test of Medigen’s R&D strategy, which features a 1,000-subject Phase 3 immune-bridging study designed to compare the effects of MVC COVID-19 and AstraZeneca’s COVID-19 vaccine.
 
In a statement, Medigen CEO Charles Chen said he is “encouraged by receiving a positive provisional determination by the TGA and to be considered eligible for the provisional pathway.”
 
TGA Notice, Press Release

 

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