Regulatory Focus™ > News Articles > 2021 > 4 > Asia-Pacific Roundup: TGA revises guidance on clinical evidence for comparable devices

Asia-Pacific Roundup: TGA revises guidance on clinical evidence for comparable devices

Posted 06 April 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA revises guidance on clinical evidence for comparable devices

Australia’s Therapeutic Goods Administration (TGA) has updated its clinical evidence guidelines for medical devices, almost totally rewriting the section on comparable devices including substantially equivalent products.
 
A comparable device is a product “with related function chosen by the manufacturer to inform the clinical evaluation of the device in question,” according to the new section. The first step in the process is to choose a suitable comparable device. Some comparable devices are treated as substantially equivalent as there are no clinically significant safety or performance differences.
 
The extent to which clinical evidence for a comparable device can be used to inform safety and performance evaluations depends on how similar the products are, according to TGA. The agency expects device developers to select products with characteristics that are “broadly similar” and take into account “how differences may affect the clinical safety and performance of the device.”
 
Clinical evidence for comparable devices can form part of regulatory submissions but in most cases a company will need direct clinical data on its own product. While all comparable devices can provide some evidence, data on substantially equivalent devices is the most useful. TGA will accept evidence from substantially equivalent devices as the sole source of clinical data for showing compliance with the Essential Principles.
 
Other regulators approach substantial equivalence slightly differently from TGA, in part because of legislative differences. TGA’s view is that “all relevant clinical, technical and biological characteristics of the devices should be compared (preferably with the aid of tables) and discussed.” The agency also expects applicants to undertake a “sufficiently detailed critical analysis” to demonstrate the similarity of the devices and have a “suitable clinical expert” endorse the assessments. 
 
If technical data on a comparable device are unavailable, TGA said “a robust method of analysis that quantifies this may be provided as an alternative.” TGA said reference to a relevant ISO standard may be helpful. The agency will factor in substantially equivalent determinations by its regulatory peers into assessments.
 
Other subsections of the rewritten text address predicates, defined by TGA as “comparable devices that represent a logical starting point for gathering clinical evidence,” and the comparison of the characteristics of products. TGA considers clinical, technical and biological characteristics when considering the comparability of products and subjects high-risk devices to particularly thorough evaluations.
 
TGA Guidance
 

Philippine FDA seeks feedback on guidance for medical device traders

The Philippine Food and Drug Administration (FDA) has issued draft guidelines on its new eServices Portal System for medical device traders and distributors. FDA issued the guidance to support the transition of license to operate (LTO) applications via the system.
 
The guidance includes the information applicants need to share in their submissions, such as the GPS coordinates of their facility and proof of business name registration. Other requirements are tied to the type of variation. For example, filings for a change in distributor activity require a contract that shows the new activity.
 
Whatever the specific requirements, FDA expects applicants to file information through the eServices portal. Users can now obtain access without creating an account and password. FDA will check the submission meets its requirements and, if so, send the LTO to the registered email address of the applicant.  
 
FDA may reject submissions for multiple reasons, such as the failure of the applicant to meet the technical requirements. The guidance states rejection “is without prejudice to re-application” but will result in “outright forfeiture of payment.”
 
FDA Guidance
 

TGA probes thrombosis case in recipient of AstraZeneca vaccine

TGA is carrying out an “active investigation” of a case of thrombosis in a recipient of AstraZeneca’s COVID-19 vaccine. The individual is the first person in Australia to present with thrombosis involving abdominal blood vessels and low platelets after receiving the vaccine.
 
The agency is working with its Vaccine Safety Investigation Group to evaluate the case and its potential link to the vaccine as well as meeting with peers at the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Authority to discuss the case and other similar events seen in Europe.
 
Like other regulators, TGA’s position is that the benefits of vaccination continue to outweigh the risks. None of the regulatory agencies have identified a causal relationship between the AstraZeneca vaccine and the cases of thrombosis.
 
TGA has provided guidance to healthcare professionals about symptoms that may indicate a patient is suffering from thrombosis and advice on how to diagnose and treat the condition. The advice notes the similarity of the cases to heparin-induced thrombocytopenia.
 
TGA Notice, More
 

Philippine FDA warns public about counterfeit COVID vaccines

“Criminal groups and unscrupulous enterprising people” are counterfeiting COVID-19 vaccines in the Philipines, according to a warning from the country’s FDA.  
 
None of the specific examples of counterfeit COVID-19 vaccines cited by FDA involve products found in the Philippines. However, FDA sees the discovery of counterfeit vaccines in Mexico and South Africa as a cause for concern in the Philippines.
 
FDA said no approved COVID-19 vaccines are available for sale in pharmacies, other drug outlets or online in the Philippines. The government is the only procurer of COVID-19 vaccines and administers them at vaccination sites authorized by the Department of Health. FDA is asking people to inform it of potentially fake and falsified vaccines.
 
FDA Notice
 

China tracks jump in medical device adverse event reports in 2020

China’s National Medical Products Administration (NMPA) has reported a 35% increase in medical device adverse event reports in 2020. The jump follows a four-year period in which the number of reports rose 12%.
 
Serious adverse events were noted in 6% of reports and deaths occurred in 0.04% of the reports. The significant acceleration of the rate of adverse event reporting follows efforts to improve the system.
 
NMPA highlighted the increase in registered users and improved coverage across China’s provinces as changes in 2020. The number of registered operating companies, which are the biggest group in the system, increased by 12% last year.  
 
NMPA Report (Chinese)
 

Other news:

The Indian government has published its National Policy for Rare Diseases, 2021. The document is intended to spur local rare disease research, development and manufacturing to bring down the cost of treating orphan indications. A national hospital-based rare disease registry is also envisaged to provide data to support R&D in India. Government Notice, Final Report
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has shared adverse event data from the 2020 seasonal influenza vaccination campaign. New Zealand distributed a record 1.7 million flu vaccine doses in 2020. Medsafe received 275 reports of suspected adverse reactions. Medsafe Notice

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe