Asia-Pacific Roundup: Industry backs TGA software carve-out plan

Australia’s Therapeutic Goods Administration (TGA) has received broad support for its proposal to exempt or exclude some software-based medical devices from regulations.
 
In a consultation, TGA asked which types of software-based products might be exempted from inclusion in the Australian Register of Therapeutic Goods or excluded from regulation by TGA on the grounds that they are regulated sufficiently by another body. Disease-management software, for example, might be exempted, TGA noted.
 
AbbVie and Boehringer Ingelheim both voiced support for TGA’s plan to carve out some products from regulations, leading the agency to conclude most respondents were supportive of the idea. Many respondents called for TGA to continue to play a role in the monitoring or “stewardship” of devices that are exempted or excluded from its regulations. TGA also noted broad support for a carve out for clinical decision support tools.
 
Many of the details remain undecided, though. Respondents pushed TGA for clearer “definitions and a shared understanding of risk and how it may inform a carve out.” TGA also received differing views on whether clinical decision support systems should only be carved-out under certain conditions.
 
Other concerns included the potential for clinical decision support systems featuring artificial intelligence or machine learning to become de facto decision makers, necessitating ongoing regulatory oversight, and privacy issues linked to mobile apps and other direct-to-consumer software-based medical devices.
 
TGA now is going over the feedback with a view to holding further discussions to inform the development of a proposal to the Australian government. TGA wants its proposal to “broadly align” with practices in other countries.
 
Consultation Responses
 
Australia establishes new approach to fecal transplant regulation
 
The Australian government has published a therapeutic goods order detailing a new approach to the regulation of fecal microbiota transplants (FMT). Officials finalized the text after a TGA consultation that identified concerns with the proposals and led to multiple changes.
 
In the final order, the government sets out requirements related to the screening of potential stool donors, both through assessments of their medical and social histories and testing of their samples. The order states samples must be tested “as soon as practicable after collection ... and within the claimed sample stability timeframe specified” for the in-vitro diagnostic (IVD). 
 
The approach to the use of IVDs was one point of contention during the consultation. The Australian Consensus Working Group told TGA “imposing a regulatory requirement to use tests that currently do not exist is problematic” after reviewing the agency’s draft standards and an early version of the order.
 
Australia’s FMT industry will have longer than originally anticipated to adapt to the changes. Last month, the government passed an amendment that delayed the imposition of the FMT regulatory requirements by six months due to COVID-19. The rules are now set to come into force at the start of July 2021.
 
Therapeutic Goods Order, TGA Notice, Consultation Responses
 
China’s CDE creates COVID-19 vaccine development guidelines
 
China’s Center for Drug Evaluation (CDE) has published a slate of guidance documents covering different aspects of the research and development of vaccines against the SARS-CoV-2 coronavirus.
 
The first document presents technical guidelines for the development of COVID-19 vaccines. CDE has also shared four other documents that cover topics such as the guiding principles of mRNA vaccine research and the nonclinical evaluation of COVID-19 prophylactics. The publication of the texts follows the initiation of Phase 3 COVID-19 trials by Chinese companies including Sinopharm.
 
In the guideline on clinical development, CDE sets 50% protection as the efficacy bar that coronavirus vaccines need to clear to come to market, in line with the bar set by the US Food and Drug Administration. The CDE guideline also discusses early and late-phase trial design, subject selection and ways to quickly advance vaccines while minimizing patient safety risks.
 
Some of the guidelines discuss the different types of vaccine in development and details specific to them but mRNA is the only approach with a dedicated document. The technology underpins vaccines in development at BioNTech, CureVac and Moderna Therapeutics.
 
CDE Notice (Chinese)
 
Philippine FDA shares guidance on third-party manufacturing
 
The Philippine Food and Drug Administration (FDA) has created draft guidance to help companies that work with third parties to manufacture drugs to be imported into the country.
 
FDA identified the need for additional guidance when implementing an administrative order on good manufacturing practices (GMPs) for overseas companies. The issue related to licenses “issued to a marketing company that avails the manufacturing facilities owned by a drug manufacturer.” FDA linked such “loan licenses” to delays to the processing of applications.
 
The draft guidance released last week is intended to eliminate those problems. FDA has clarified the process for applicants that were unable to provide a GMP clearance certificate due to their use of a loan license. The guideline also covers the process for pending and incoming applications.
 
FDA is accepting feedback on the draft until 21 August.
 
FDA Guidance
 
New Zealand’s Medsafe updates pharmacovigilance guideline
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has updated a guideline on pharmacovigilance. Medsafe made tens of small changes in revising the document.
 
Changes to version 2.2 of the text include the replacement of the term “efficacy” with “therapeutic effect” at multiple points in the document. Medsafe made the switch as “efficacy is something that would be determined from a clinical trial, whereas a lack of therapeutic effect is something that may be observed in an individual patient and therefore reported as an adverse event.”
 
The change in terminology is one of several revisions to the section on therapeutic effect. Medsafe also clarified that companies only need to report a lack of therapeutic efficacy if it is considered to be serious, for example when a vaccine fails to protect against a disease, and removed a requirement to report when drugs fail to work as hoped when used off-label.
 
Other changes include the clarification that companies do not need to file reports of cases occurring outside New Zealand unless they know the product was dispensed or purchased in the country.
 
Medsafe Guideline, More
 
Other News:
 
TGA has updated its user guide to the evaluation of substances for use in listed medicines and assessed listed medicines. The new version of the document, which TGA originally published in 2019, features changes to include assessed listed medicines and revisions to sections on applications to vary a determination. User Guide
 
India has extended the application of the current ceiling price on knee implants by one month. The current ceiling was due to be revised last week. However, the government has extended the use of the existing ceiling price until the middle of next month. India’s National Pharmaceutical Pricing Authority shared details of the change. Government Order
 
TGA has created a fact sheet to explain the pathways for exporting ventilators from Australia. The notice comes months after TGA exempted ventilator suppliers from some rules in light of the threat posed by COVID-19. TGA Notice