Asia-Pacific Roundup: TGA seeks feedback on priority pathway for cell therapies

RoundupsRoundups | 01 March 2022 |  By 

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into the feasibility, potential eligibility criteria and determination process for a proposed priority review pathway for biologicals such as cell therapies.
Trade group Medicines Australia used a recent parliamentary inquiry to push for biologicals – goods that contain or are derived from human cells or tissues – to become eligible for priority review and provisional registration. AusBiotech and other commenters also called for changes to TGA’s approach, leading the parliamentarians to summarize that current pathways may be inadequate.
TGA has responded by proposing the creation of a pathway to accelerate the assessment of treatments for life-threatening diseases or seriously debilitating conditions. The agency has worked in the past to facilitate early access to some products but lacks a dedicated pathway.
TGA plans to establish a legislated timeframe of 150 working days for priority review, consistent with benchmarks set in the US and EU and Australia’s existing pathway for prescription medicines. When deciding if a treatment is eligible for priority review, TGA plans to assess the seriousness of the disease, its impact on patients, the availability of effective interventions and whether the biological will improve outcomes. TGA expects applicants to submit “robust evidence from summaries of full study reports” to show there is a high probability a biological will provide patients with a clinically relevant benefit.
TGA wants to know whether people and organizations affected by the proposal support the creation of a priority review pathway for biologicals and what impacts they foresee the change having. The agency is also seeking feedback on whether it should change the eligibility criteria.
If a priority review pathway is implemented, TGA also will establish a determination pathway for deciding if a biological is eligible. TGA plans to hold optional pre-submission meetings three to six months before the applicant files for registration. Applicants that skip the meeting step can notify TGA of their intent to lodge a determination application. TGA recommends companies file the determination application itself three months before submitting for registration. The agency aims to decide on determination applications within 20 working days.
If priority review status is granted, the agency is proposing that an applicant be given six months to provide the full submission. The agency plans to publish the outcomes of approved applications for priority review determination of biologicals but wants to gather feedback on the plan first.
TGA is accepting feedback on the proposal until 28 March.
TGA Consultation, More
Industry resistance drives TGA to assess next steps for adverse event plan
TGA’s plan to require healthcare facilities (HCFs) to report adverse events (AEs) linked to medical devices has run into opposition from organizations including the Medical Technology Association of Australia (MTAA).
While almost three quarters of respondents to a recent consultation about the proposal were in favor of mandatory reporting, TGA is taking another look, based on “valid concerns and issues” raised during the consultation.
“It is evident that if mandatory reporting were to be introduced, work would need to be undertaken within healthcare facilities, their existing systems, and information collection points to facilitate accurate and timely reporting. Additional work would also be needed to increase awareness of the scope of benefits of mandatory reporting, including through education and communication materials,” TGA said.
TGA will work with the Australian Commission on Safety and Quality in Health Care (ACSQHC), state and territory health departments, and private and day hospitals going forward. ACSQHC is willing to take the lead on establishing “mandatory reporting within the existing frameworks for hospital quality assurance and accreditation processes” to minimize additional regulatory burdens, TGA said.
The rethink follows feedback from organizations including MTAA, which said it was “generally supportive of any initiative that increases awareness and reporting of AEs,” but did not support mandatory reporting by healthcare facilities (HCF).
“We do not support mandatory reporting by HCFs to TGA. Mandatory reporting by HCFs will lead to unintended impacts and consequences. Multiple sources of AE reporting will pose a challenge to match cases with those already reported directly to sponsors. This is especially difficult when there is insufficient information provided in the report and/or when reporter details are marked as confidential,” according to MTAA.
The best way to ensure the accuracy of the data is to have HCFs report directly to the sponsor, according to MTAA. That approach will ensure all pertinent information is submitted to TGA, reducing the need for the agency to send questionnaire letters or requests for information. MTAA wants TGA to consider ways to strengthen this system, such as a sponsor inspection program and investment in the education of HCFs about reporting directly to sponsors.
TGA Summary, MTAA Response, More
Philippine FDA starts consultation about regulation of online medicine sales
The Philippine Food and Drug Administration (FDA) is seeking feedback on guidelines on licensing the online sale of medicines.
FDA already allows licensed sites with a physical presence to offer online ordering services, provided they apply for approval. The pandemic has increased interest in platforms that enable consumers to buy medicines without visiting a pharmacy, leading FDA to propose guidelines intended to ensure the safety, quality, efficacy and purity of health products sold online.
The guidelines limit orders using online platforms to non-prescription, FDA-registered products. All sites that process online orders will need to comply with good distribution and storage practices to ensure the integrity and stability of the products they sell and obtain a license to operate for e-pharmacy activities. Sites that directly sell to non-retail establishments such as manufacturers will not need the licenses. 
FDA is accepting feedback until 28 March.
FDA Consultation
TGA provisionally approves Evusheld for COVID pre-exposure prophylaxis  
TGA has granted provisional approval to AstraZeneca’s long-acting antibody combination Evusheld for pre-exposure prevention of COVID-19.
While vaccines offer the best protection against COVID-19 to most people, there is an unmet need in the immunocompromised and individuals with a history of severe adverse reactions to components used in vaccines. Evusheld is designed to address that unmet need by giving people antibodies against the virus to provide protection from symptomatic COVID-19 for at least six months.
TGA’s provisional approval covers the use of Evusheld in people aged 12 years and older weighing at least 40 kg. The Australian government has secured 36,000 courses of the treatment from AstraZeneca.
TGA Notice


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