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Regulatory Focus™ > News Articles > 2021 > 10 > Asia-Pacific Roundup: TGA moves to make patient information rules more flexible after consultation

Asia-Pacific Roundup: TGA moves to make patient information rules more flexible after consultation

Posted 19 October 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA moves to make patient information rules more flexible after consultation

Australia’s Therapeutic Goods Administration (TGA) is set to allow more flexibility in how medical device patient information materials are provided after holding a consultation into possible reforms.
 
TGA has been phasing in requirements for sponsors of implantable medical devices to provide patient information leaflets (PIL) and patient implant cards (PIC) since late 2018. The experience has triggered feedback from consumers, healthcare professionals, surgeons, hospitals and medical device companies about impracticalities and challenges associated with implementation. In response, TGA held a consultation into plans to offer more flexibility and exempt devices from the requirements.
 
Having reviewed 34 responses to the consultation, TGA plans to make four changes to the rules. TGA will allow more flexibility by allowing a range of formats, such as electronic materials, that are given to the patient pre- or post-surgery. The flexibility will mean materials do not necessarily need to be supplied with the device in the packaging.
 
Other changes include the exemption of pedicle screws and devices that are “absorbed by the body within a defined time period” from the requirement to supply a PIC. Both sets of devices will still need a PIL, although in the case of pedicle screws it “could be incorporated into a system patient information leaflet where appropriate.” The final change is to empower a TGA delegate to consider “exempting other devices where clinically appropriate to ensure alignment with Europe.”
 
TGA, which will now seek agreement with the Australian government on the changes, settled on the revisions in light of the feedback it received. In its summary of the responses, TGA said almost all the respondents agreed with plans to offer information in a range of formats. Medical device industry respondents said offering electronic materials would lower costs. TGA also found most respondents agreed it is unnecessary to provide PICs for pedicle screws and absorbed medical devices.
 
The request for the power to exempt other devices positions TGA to further tweak the rules. TGA said there was “strong representation” for exempting reloads with staple line reinforcement, sutures with pledgets and pledgets alone from PICs. Another respondent recommended exempting devices such as spinal rods, suture anchors and bone screws to align with European requirements.
 
TGA plans to update its guidance documents to address concerns raised in the consultation, as well as to provide continued education “including clear messages to relevant groups such as hospitals, surgeons, clinicians and procurement officers in relation to the implementation of patient information materials.”
 
TGA Notice
 
Chinese plans for medical device standardization gather pace with political support
 
China’s National Medical Products Administration (NMPA) has discussed efforts to increase medical device standardization, including the designation of 10 model enterprises for the implementation of medical device standards.
 
The Chinese government set out plans to increase standardization across all industries earlier this month. The plan is to enact a “market-driven, government-guided and enterprise-oriented standardized development pattern featuring mass participation and opening-up and integration” to help China meet its long-term development goals. While the long-term goal covers up to 2035, there are nearer-term plans to make reforms by 2025.
 
Details of how the medical device industry will support the initiative emerged at the China Medical Device Standards Forum, an event sponsored by NMPA. At the event, the China Association for Medical Devices Industry announced, “the first group of 10 model enterprises for the implementation of medical device standards.” The enterprises will serve as a benchmark for device standardization.
 
China currently has 1,835 medical device standards. NMPA outlined how it has worked in recent years to “deepen the reform and innovation of medical device standardization, improve the legal system for medical device standards and advance plans to upgrade standards for medical devices.”
 
NMPA Notice, ChinaDaily, More (Chinese)
 
Pakistan finalizes overhaul of regulation of contract manufacturing organizations
 
The Drug Regulatory Authority of Pakistan (DRAP) has finalized changes to the regulation of contract manufacturing. DRAP released draft changes for consultation in June and has made some changes in response to the resulting feedback.
 
Most of the proposal is unchanged from the draft version. DRAP is still introducing a new definition of “contract manufacture” and changing the rules on contracts between third-party manufacturers and their customers. The rule changes put more emphasis on quality, mandating written quality agreements and the establishment of a quality management system.
 
Changes to the draft include tweaks to the definition of contract manufacture. DRAP’s final changes expand on the foreign pharmaceutical companies that can outsource manufacturing, adding that the rule applies to businesses that have “drug sale licence in Pakistan for their research, innovator, originator drug products or drug products already registered for sale by any reference regulatory authorities adopted by the Registration Board.”
 
DRAP has also completely changed the text about one situation in which outsourcing is allowed. In the draft, DRAP said manufacturing can be outsourced for a “special case and for genuine reasons,” such as “break down, renovation, up-gradation.” The final text keeps the intent but features new wording, explaining that licenced pharmaceutical manufacturing units can outsource when the Registration Board certifies that they cannot maintain output for reasons beyond their control.
 
DRAP Notice
 
Roche gets TGA approval for COVID-19 rapid antigen self-test as Australia lifts ban
 
Roche has received TGA approval for a COVID-19 rapid antigen self-test, putting it in line to be one of the first companies to start selling the diagnostics when Australia lifts its ban on 1 November.
 
TGA set the stage for the speedy approval of COVID-19 rapid antigen self-tests in the run up to the official date for the lifting of the ban by seeking expressions of interest from diagnostic suppliers and sharing guidance on the requirements for approval. The groundwork enabled TGA to approve five tests in a few days last week.
 
Roche, which plans to supply a test made by SD Biosensor, is one of three sponsors to get approval. AM Diagnostics has received approval for three tests. Medsupply Australia has received approval for one test.
 
The materials prepared to accompany each test feature instructions for use and overviews of the data generated to support use of the diagnostics. Roche received TGA approval on the strength of a study that found the test correctly identified 82.5% of the 40 infected self-testing subjects. The rate of detection rose to 91.2% among people with relatively high viral loads.
 
TGA Notice
 
TGA shares guidance on gaining consent for essential principle noncompliance
 
TGA has released guidance on when and how sponsors can seek consent to import, supply or export medical devices that do not meet an essential principle. The guidance explains that the application process is moving from a paper-based form to an online system.
 
So far, TGA has completed the first phase of the transition by releasing an online application form to replace the old paper-based process. The online form and associated guidance are currently available in the TGA consultation hub. In the next phase of the transition, TGA will move the online form to the TGA Electronic Business Services (tBS).
 
As part of the move to tBS, TGA will add new functionality. The proposed changes include the addition of the ability of sponsors to view current and previous applications. 
 
TGA Notice

 

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