Asia-Pacific Roundup: TGA proposal warns of continuing cost pressures

Australia’s Therapeutic Goods Administration (TGA) proposes to increase industry fees for 2022-2023 by 2.6%, based on it’s long-established index factor, despite continuing cost pressures caused by limited revenue growth and increases in costs not recovered by those fees.
 
The increase is forecast to generate an additional AU$ 4.6 million ($3.3 million) for TGA – but falls short of the 3.3% rise TGA calculates would be needed to cover its costs. TGA almost always uses the indexation factor to determine its fee increases, with 2012-2013 a rare example of a year when it imposed a higher rise.
 
TGA detailed a mix of rising costs and flatlining revenues in a description of its financial situation. Spending on mandated and non-cost recovered activities has risen in recent years, with TGA predicting the outlay in 2022-23, AU$ 28 million, will be almost double that of 2018-2019. TGA is spending more on medicine shortages and compliance, enforcement and litigation than in the recent past. COVID-19 also is a factor.
 
“There has been a significant increase in consumer education and communications, sponsor support, and compliance and enforcement activities. While fees and charges partially cover the costs of approving and regulating COVID-19 treatments and vaccines, a rolling review of data is very expensive and there has been a remarkable increase in postmarket efforts in respect of these products,” TGA wrote.
 
The cost increases are occurring at a time when the number of products in the Australian Register of Therapeutic Goods (ARTG) is flat. TGA saw a 4% increase in ARTG entries in 2019-2020, with devices related to COVID-19 accounted for 90% of the rise. In 2020-2021, ARTG entries rose 1%, mainly due to new Class IIa medical devices. TGA noted that the agency “does not anticipate a significant increase in ARTG entries in 2022-2023.”
 
The agency intends to create a new payment for clinical trial variation applications. In the past, Australia lacked legislation allowing variations to Clinical Trial Approvals (CTAs), leading TGA to treat requests for changes as entirely new applications. A change in the legislation means TGA now has a variation process, leading it to propose fees ranging from AU$ 510 to AU$ 7,670 to change CTAs. The proposed fees are equal to 28% of a new CTA application fee.
 
TGA has already discussed the proposals with 13 trade groups including Medicines Australia. The trade groups were largely supportive, although medical device bodies raised “concerns about the impact of the COVID-19 pandemic on supply chain and general consumer demand, increasing pressure on business margins and at times even forcing businesses to shut down.” TGA is now seeking feedback from the wider industry. The consultation closes on 7 March.
 
TGA Notice, Consultation Document
 
Australian medicinal cannabis reforms on track as TGA makes progress
 
Australia is on track to commence its reforms of the requirements for medicinal cannabis manufacturing, labeling and packaging in March, according to an update from  TGA.
 
The planned reforms, which follow a consultation that closed one year ago, are intended to enhance the quality and safety of medicinal cannabis by applying equivalent good manufacturing practice (GMP) requirements to imported and domestically produced products. TGA has now begun preparations for the reforms.
 
So far, TGA has liaisoned with the Office of Best Practice Regulation, which determined a Regulatory Impact Statement is not required, and notified the World Trade Organization (WTO) about its plans. The WTO notification is open for comment until 20 February.
 
TGA now is drafting an updated TGO 93 and associated guidance documents and preparing amendments to the Therapeutic Goods Regulation 1990 and the Narcotic Drugs Regulation 2016. The agency is also finalizing the length of the transition periods to the new rules, which will require imported medicinal cannabis products to be made in accordance with GMPs.
 
TGA Notice
 
Malaysia’s MDA rolls out updated medical device online application system
 
Malaysia's Medical Device Authority (MDA) has introduced an updated version of its centralized online application system. The updated system, MeDC@St2.0+, went live on 1 February with new features for change notification and other processes.
 
MDA’s revisions to the change notification module include the combination of Category 2 and Category 3 changes in an application using a single submission ID number and the addition of the ability to download and print change notification letters directly from MeDC@St2.0+. Those features were absent from the earlier version of the system, which launched in July 2013.
 
Elsewhere, MDA made changes to two clinical research sub-modules. The device study sub-module now allows users to make notifications such as adverse event reporting and scheduled progress reports online until the completion of the trial. The clinical research use sub-module features a new online form and a structured subsequent notification process to facilitate repeat notifications.
 
MDA Notice
 
TGA probes use of false documentation to illegally import COVID tests
 
TGA is working with the Australian Federal Police to investigate the alleged use of false documentation to support the illegal importation and supply of unapproved rapid antigen tests for COVID-19.
 
The false documentation is a letter purportedly issued by Australia’s Minister for Health that appears to exempt a company based in the state of New South Wales from the need to include its product in the Australian Register of Therapeutic Goods prior to importation and supply. TGA has never granted such a special exemption.
 
TGA disclosed details of the investigation the day after updating its instructions for sponsors who are interested in supplying COVID-19 self-tests. The update provides additional information on importing COVID-19 test kits, explaining that sponsors need to meet the Australian Biosecurity Import Conditions.
 
The revised webpage also points readers toward information from the Department of Agriculture, Water and the Environment about the importation of rapid antigen tests and to rules to minimize price gouging.
 
TGA Notice, More
 
The Philippines acts to strengthen national reference laboratories during pandemics
 
The Philippines has updated its policy and mandate for national reference laboratories to enable them to better respond to the needs of the health sector, particularly during outbreaks and pandemics.
 
Officials previously established six sites to create a public health laboratory network. In the current crisis, the laboratories have offered PCR testing and worked with the Philippine Food and Drug Administration to ensure the quality and performance of COVID-19 antigen, antibody and molecular tests.
 
The new government policy is intended to give national reference laboratories “the budget, manpower complement, and mechanisms for sustainability.” Officials also aim to “institutionalize and harmonize enabling mechanisms” and strengthen the sites “through networking, partnership and collaboration with other international reference laboratories.”
 
Specific objectives include the addition of “state-of-the-art equipment, infrastructure and application software” and the provision of the supplies, reagents, quality control materials and other resources the laboratories need to execute their responsibilities.
 
Government Notice