Asia-Pacific Roundup: TGA cancels three breast implants

RoundupsRoundups | 03 November 2020 |  By 

Australia’s Therapeutic Goods Administration (TGA) has cancelled three breast implants after their sponsors failed to demonstrate the safety and performance of the devices.
TGA suspended the devices from JT Medical and Euro Implants a year ago in response to evidence of a link between certain implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). At that time, TGA gave JT Medical and Euro Implants and two other sponsors six months to share information on the safety and performance of their devices.
JT Medical and Euro Implants had “provided evidence that they were working towards compliance with the requirements” for three devices by the time the original deadline was up, leading TGA to give them another six months to share information. Another five breast implants, including one sold by Euro Implants, were cancelled from the Australian Register of Therapeutic Goods (ARTG) at that time, in most cases by the sponsor.
TGA now has cancelled the three implants based on information provided by JT Medical and Euro Implants. The ARTG cancellation affects JT Medical’s Sublime Line and 4Two Line implants and Euro Implants’ cristaline paragel cohesive gel implant.
None of the eight devices covered by TGA’s original action now may be sold in Australia. Women who have  the implants need not to have them removed unless they have BIA-ALCL symptoms as the risk of surgery may be greater than that of the very rare cancer, according to TGA.  
TGA Notice
Philippines warns of ‘rampant’ use of US FDA logo to promote medical devices
Officials have warned of the “rampant” use of the US Food and Drug Administration (FDA) logo on the promotional materials and labels of medical devices sold in the Philippines.
The Philippine FDA said companies are using the logos of regulators of other countries, notably that of its US counterpart, on advertisements and labels of face masks and other medical devices. Adding the logo of foreign regulatory agencies to materials linked to medical devices sold in the Philippines contravenes rules prohibiting the use of the initials FDA without written permission.
The agency has advised people to check to see if a product is approved before purchasing and has provided information on locating and identifying the correct registration number format. The agency also has asked people to report unauthorized usage of regulatory logos.
The Philippine FDA issued the notice shortly before sharing warnings about several medical devices, including a face mask that is being sold despite not going through the regulatory evaluation process.
FDA Notice
India proposes imposing stronger rules on sale of tapentadol
The Indian government has proposed reclassifying tapentadol as a Schedule H1 product, limiting sales to people with valid prescriptions.
Johnson & Johnson brought tapentadol to market as Nucynta in the US in 2009 before selling the asset to Depomed six years later. In the US, Nucynta is a prescription-only product that is subject to a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of opioid addiction, abuse and misuse. Yet, in India tapentadol is “available more or less over the counter,” according to a recent paper by researchers at India’s National Institute of Mental Health and Neurosciences.
India established Schedule H1 in 2014, primarily to stop OTC sales of antibiotics. Schedule H1 products must carry the Rx symbol and a warning and should only be dispensed to people with valid prescriptions.
India proposed rescheduling tapentadol after researchers published data on its use in the country. The aforementioned paper found the number of people seeking treatment for tapentadol abuse more than doubled in 2019, contributing to the researchers concluding the drug “is being widely abused, and urgent regulatory measures are required.”
Gazette Notification
Philippine FDA updates approach to facility licensing
The Philippine FDA has shared details of changes to its approach to License to Operate (LTO) filings for drug non-manufacturing establishments and radiation facilities. FDA is making the changes as part of an effort to improve and streamline government services.
As of 3 November, FDA will accept LTO applications from drug distributors, sponsors, clinical research organizations and other drug non-manufacturing organizations via its eServices portal. FDA shared guidance on the new LTO application process last month without providing details of when it would fully implement the system.
FDA disclosed 3 November as the start date of the change to the process for drug non-manufacturing establishments around the same time as it issued a separate notice aimed at radiation facilities. The second notice invited radiation facilities to participate in the pilot implementation of FDA’s Radiation Regulation Division portal.
Starting next week, radiation facilities in the capital region can help pilot the use of the portal to seek and renew LTO and Certificate of Facility Registrations. FDA will expand the pilot project to cover all of the Philippines next month. Organizations that want to use the portal first need to register. FDA shared details of the process in an annex to its notice about the start of the pilot project.
Non-manufacturer LTO, Radiation Pilot
TGA issues AU$190,000 in fines in continuation of COVID-19 crackdown
TGA has disclosed almost AU$190,000 ($134,000) of fines in a single day. The flurry of fines continues the agency’s clampdown on people and organizations alleged to have unlawfully imported or promoted products related to COVID-19.
JCIN received the largest of the latest batch of fines, AU$79,920, over its alleged promotion of pulse oximeters, KN95 respirator masks and non-contact infrared thermometers. The company allegedly promoted the devices as approved by TGA. The agency also accused JCIN of advertising KN95 masks with an ARTG that does not exist.
TGA said the promotions ran on The CPAP Clinic’s website. JCIN and The CPAP Clinic share a director. TGA fined The CPAP Clinic $AU13,320 over its role in the alleged breaches of the advertising rules.
Australian officials disclosed the fines on the same day as sharing news of the punishment of four other organizations. TGA fined Cleanstar AU$53,280, the second largest amount in the crop of fines, for allegedly unlawfully importing infrared thermometers and breaching the rules on the promotion of face shields and surgical face masks, again by listing them as TGA approved.
TGA Notice, More
Other News:
The Philippine FDA has investigated influenza vaccines used in the country in response to the deaths that occured in South Korea. None of the products used in Korea have been imported into the Philippines. A search of the national database of adverse events found no reports of life-threatening reactions. The analysis led FDA to strongly recommend immunization against influenza. FDA Notice
The Philippine FDA has shared details of the progress of applications to study COVID-19 vaccines in the country. IP Biotech, a Philippine vaccine importer, is the sponsor of the most advanced study, which has completed evaluation by a vaccine expert panel and is now undergoing ethics review and FDA evaluation. FDA Notice


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