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Regulatory Focus™ > News Articles > 2020 > 7 > Asia-Pacific Regulatory Roundup: TGA seeks data matrix code feedback

Asia-Pacific Regulatory Roundup: TGA seeks data matrix code feedback

Posted 07 July 2020 | By Nick Paul Taylor 

Asia-Pacific Regulatory Roundup: TGA seeks data matrix code feedback

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on whether its proposed  standard for serialization and data matrix codes is clear and applies to the right medicines.
 
As it stands, Australia is yet to mandate serialization or the use of data matrix codes. However, with the European Union adopting data matrix codes and United States track-and-trace law specifying the use of similar two-dimensional codes, TGA has put forward a standard to ensure it is aligned with the policies of its international peers and to support early adopters of the technology.
 
The standard dictates the information that must and can be encoded, plus how it must be formatted. TGA plans to require data matrix codes to carry the Global Trade Item Number (GTIN), batch or lot number, expiry date and serial number. The list is based on international requirements and policies that apply to blood and blood products distributed in Australia.
 
TGA expects manufacturers to format their data matrix codes in accordance with requirements set out in the GS1 General Specifications. The agency also wants manufacturers to position the code in a way that minimizes inadvertent reading of other codes and ensure it remains machine readable for the shelf life of the product. Ideally, TGA wants companies to locate a mandatory text version of the encoded information next to the code.
 
Only a subset of medicines will need to comply with those requirements. TGA plans to apply the standard to medicines that are serialized, either at the primary pack or unit dose level, or feature a data matrix code that contains a GTIN on the primary pack.
 
TGA is seeking feedback on the draft standard until 13 August. The agency put nine questions to the industry about the clarity and comprehensiveness of the draft standard and the effects it will have on businesses. If TGA enacts the standard, it plans to give the industry 12 months to make any required changes.
 
Consultation Paper
 
TGA starts remote GMP inspections of some overseas manufacturers
 
TGA has begun performing remote good manufacturing practice (GMP) inspections of some foreign companies, targeting sponsors that have filed certification applications or been identified as working with a manufacturer that requires a remote GMP assessment.
 
Like its international peers, TGA shut down its foreign GMP inspection program as COVID-19 put a stop to overseas travel. Four months later, TGA wants companies targeted for remote inspections to nominate an authorized responsible person to host the visit. The company must give the host the required authority and IT support “to ensure a smooth remote inspection process can take place.”
 
The host will serve as TGA’s point of contact at the site and complete a pre-inspection checklist sent by the agency. The checklist will help TGA determine if a site is equipped to host a remote inspection.
 
TGA is yet to share the checklist publicly but its description of the remote inspection process points to some of the capabilities that manufacturers will need to host the agency. Manufacturers are expected to record videos of the site so TGA inspectors can have a virtual tour. TGA also wants manufacturers to provide it with guest read-only logins for their quality management systems.
 
Other requirements include the ability to livestream video and provide English-language interpreters with excellent technical knowledge. TGA expects manufacturers to make staff available at pre-agreed times when “time zone differences need to be taken into consideration.”
 
TGA Notice, More
 
Philippine FDA drafts plan for preventing viral spread at its offices
 
The Philippine Food and Drug Administration (FDA) has set out how it plans to limit foot traffic and face-to-face interactions at its offices to reduce the spread of the SARS-CoV-2 coronavirus.
 
FDA drew on the US Centers for Disease Control and Prevention’s hierarchy of controls when writing the plan. The result is a strategy focused on stopping the virus from entering the agency’s offices and cutting the risk that it will be transmitted.
 
Under the plan, FDA will ask visitors to complete a health declaration form and undergo temperature checks; visitors who have a temperature exceeding 37.5℃ in two tests performed five minutes apart will not be admitted. All visitors must wear masks and comply with a one-way traffic system that sees people enter and exit the building through different doors.
 
FDA would rather people avoid visiting altogether by performing transactions online. The agency is encouraging people that do visit its offices to use contactless forms of payment.
 
Draft Plan
 
TGA reduces annual charges for some devices after industry pushback
 
TGA has halved the annual charges for medical devices on the prostheses list. The agency framed the action as a response to the suspension of elective procedures, although it also forms part of a wider dispute over the government’s handling of surgically implanted prostheses.
 
In feedback on TGA’s fee proposal for 2020 to 2021, the Medical Technology Association of Australia said companies were being asked to pay higher regulatory charges at a time when the industry is “being punished under fairly dramatic price cuts by the same Government through the cuts in the Prostheses List.”
 
Around one week after publishing that feedback TGA revealed a 50% reduction in the annual charges of medical devices on the prostheses list. Companies will now pay annual charges of AU$470 ($325) to AU$600, depending on the class of device. All Class II, III and active implantable medical devices on the list will automatically benefit for the reduced charge.
 
TGA Notice
 
India permits off-label use of convalescent plasma in COVID-19 patients
 
The Indian government has updated its COVID-19 clinical management protocol to permit off-label use of convalescent plasma.
 
In highlighting the change in policy, the Central Drugs Standard Control Organization (CDSCO) noted the prerequisites for using convalescent plasma in the treatment of COVID-19. Patients with moderate disease whose oxygen requirement is progressively increasing despite steroid use are eligible for plasma.
 
Eligible patients will receive doses ranging from 4 to 13 ml/kg and be closely monitored for several hours in case they suffer transfusion-related adverse events. Physicians should not give plasma to patients with IgA deficiency or immunoglobulin allergy.
 
The policy change comes amid a growing COVID-19 outbreak in India. Having recorded 25,000 new infections in a day, India recently became the country with the third most cases after Brazil and the US.
 
CDSCO Notice, More
 
Other News:
 
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a warning about fake versions of its website designed to steal information or money from visitors. PMDA is advising people to make sure they accurately enter its web address, https://www.pmda.go.jp, to avoid inadvertently accessing a scam website. PMDA Notice
 
TGA has published guidance to help sponsors use code tables for GMP Clearance applications. In the past, problems with the quality of GMP Clearance applications have contributed to long processing times and a backlog of filings. TGA Notice

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