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Regulatory Focus™ > News Articles > 2020 > 6 > Asia Regulatory Roundup: Medtech firms push back against TGA essential principles reform

Asia Regulatory Roundup: Medtech firms push back against TGA essential principles reform

Posted 09 June 2020 | By Nick Paul Taylor 

Asia Regulatory Roundup: Medtech firms push back against TGA essential principles reform

Australia’s Therapeutic Goods Administration (TGA) is reconsidering some aspects of proposed reforms to its essential principles for medical device safety and performance due to opposition from medtech organizations including Johnson & Johnson.
 
In September, TGA outlined plans to incorporate International Medical Device Regulators Forum (IMDRF) essential principles and European Union General Safety and Performance Requirements (GSPRs) into its own regulatory framework. A public consultation revealed widespread opposition to aspects of the proposal, notably the plan to use IMDRF materials as the basis for the essential principles put in place by TGA.
 
“We do not support alignment with the IMDRF Essential Principles,” J&J officials wrote in their response. “The majority of medical devices supplied in Australia leverage CE approval, so we believe alignment with the IMDRF principles will likely lead to regulatory divergence and increased regulatory burden for manufacturers and sponsors. Although the IMDRF [essential principles] appear to capture all the requirements from the EU GSPRs, the difference in wording will likely lead to differences in interpretation.”
 
Other respondents voiced opposition to the alignment with IMDRF. Trade group the Medical Technology Association of Australia, for example, said Australia should be guided by the EU and make compliance with IMDRF requirements optional.
 
In summarizing the responses, TGA said there was “limited support for alignment with the IMDRF Essential Principles and Principles of Labelling.” TGA is now changing its proposals based on the feedback.
 
The scope of the changes may extend beyond the role of IMDRF requirements. As TGA noted in its summary of responses, the consultation identified broad disagreement with its plan to make sponsors of software as a medical device (SaMD) products include the Australian Register of Therapeutic Goods (ARTG) number on electronic labels. GE Healthcare, in its only public comment on the TGA proposals, articulated the opposition.
 
“Adding the ARTG number to the dedicated version number screen of the software will require significant technical implementation,” GE Healthcare officials wrote in their response. “In addition, depending on customer preferences, an SaMD may be supplied with different selection of software options. This will mean the list of ARTG numbers displayed on screen will need to vary dynamically. Building this dynamic into the software would be complex.”
 
TGA Notice
 
India establishes guidelines for validating and batch testing COVID-19 kits
 
Manufacturers of COVID-19 diagnostic kits that have been authorized by the US Food and Drug Administration (FDA) need not perform further validation work under validation and batch testing guidelines from the Indian Council of Medical Research (ICMR). The policy applies to tests for
active infection with SARS-CoV-2, antibodies against the virus and RNA extraction kits.
 
Manufacturers without FDA authorization will need to validate their products, even if they have a CE mark. Depending on the type of test, manufacturers of products without FDA authorization will need to get one to three batches validated at one of 24 sites run by ICMR and other organizations in India.
 
To get a test validated, manufacturers will need to send a kit to a validation center with an “adequate number” of reagents, the methodology and other materials needed to assess performance. The site will send a validation report to the manufacturer within 15 days.
 
The same 24 sites will handle batch testing. Companies selling COVID-19 tests in India need to share a batch testing certificate when delivering a consignment. One of the validation centers will test random samples of the kits to assure their quality. 
 
COVID-19 Guidelines
 
Philippines creates process for registering foreign manufacturers during pandemic
 
The Philippine Food and Drug Administration (PFDA) has released draft guidelines to help overseas manufacturers import products during the pandemic. As it is currently impossible to inspect foreign plants, the agency wants to create interim measures that rely on remote assessments.
 
PFDA uses in-person assessments to confirm companies comply with good manufacturing practices (GMPs) and are therefore eligible to import medical products into the Philippines. In the absence of that oversight mechanism, PFDA plans to perform desktop reviews of manufacturers that currently have a notification for inspection.
 
Manufacturers in that situation will need to pay half of the typical inspection fee. If the PFDA’s GMP Inspectorate Team is satisfied a manufacturer is compliant with GMPs after performing a desktop review, it will clear the organization to proceed with drug product registration. Manufacturers that fail the desktop review will be unable to register products until in-person assessments resume.
 
When overseas inspections resume, the agency will prioritize the assessment of manufacturers that underwent desktop reviews. Companies will need to pay the remaining 50% of their inspection fee once in-person visits of overseas facilities resume.
 
If a company would rather withdraw their application for cGMP clearance, PFDA wants them to submit written notification.
 
PFDA is holding a short consultation on the proposals that ends on 10 June.
 
PFDA Notice, Draft Guidelines
 
India proposes permitting importation of unapproved drugs for compassionate use
 
The Indian government has proposed allowing healthcare professionals to import some unapproved drugs on a compassionate use basis.
 
Through planned amendments to the New Drugs and Clinical Trials Rules, 2019, the government is proposing to allow imports of drugs that are in Phase 3 testing for compassionate use in the care of patients with “life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need.”
 
To gain clearance to import a product, the medical officer of a healthcare institution will need to file an application. The submission will cover the rationale for using a drug on a compassionate use basis, a description of the manufacturing facility, data to assess the quality of the medicine and other evidence to inform the review of the merits of the request.
 
The Central Licencing Authority will decide within 30 days of receiving the application. If the authority rejects the request, the applicant can start an appeal process that involves the Indian government.
 
Successful applicants will receive a license that permits them to import the medicine for one year. Indian authorities can revoke licenses early if the importer violates the rules covering the clearance, such as the restriction on the number of doses that can be sourced and the requirements on the conditions in which they must be kept.
 
Draft Legislation
 
Other News:
 
Members of the Association of Southeast Asian Nations (ASEAN) have agreed to “refrain from taking unnecessary measures that may affect the smooth flow of essential goods” such as medical supplies. Countries in the region may still restrict the cross-border movement of goods to counter COVID-19, but will limit themselves to actions that are “targeted, proportionate, transparent, temporary, and consistent with the WTO rules.” ASEAN Notice
 
Australia’s Medicines Shortages Working Party has said the country has enough critical medicines for ventilated patients to resume elective surgery and cope with a rise in COVID-19 cases. To date, 50 COVID-19 patients in Australia have required ventilation. Modelling suggests Australia could cope with 200 ventilated patients a month from June to October and carry out usual surgical activity without exhausting supplies of drugs such as sedatives. TGA Notice

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