Asia Regulatory Roundup: Industry backs TGA plan to publish applications accepted for evaluation

Regulatory NewsRegulatory News | 14 April 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australia’s Therapeutic Goods Administration (TGA) is set to start sharing details of major innovative medicines that are accepted for evaluation. The switch to a more transparent system, which is set to take place in June, follows a consultation that drew industry support for publication.
Today, TGA does not disclose when it accepts an application for approval of a prescription medicine, nor does it provide information about the ongoing evaluation of filings unless the details are already available publicly. TGA took a step toward a new, more transparent way of working early last year when it held a consultation on whether to publish that a prescription medicine is being evaluated. The consultation presented four options.
Branded drugmakers overwhelmingly voiced support for the second option, which proposed that TGA list all applications accepted for evaluation. In explaining its decision, AbbVie said the proposal is the only one that “fully supports transparency” and “can withstand public scrutiny.” AbbVie and its peers voiced strong opposition to the other options.
Notably, branded drugmakers were critical of a proposal to treat innovator and generic medicines differently. As AbbVie sees it, applying different rules to innovator and generic medicines “will delay access to medicines for Australian patients.”
Generic drugmakers took a different view. Aspen Pharmacare, for example, argued that the timing of its filings is “commercially sensitive information,” adding that sharing details of submissions ahead of approval “is likely to lead to confusion and require additional resources.” As such, Aspen wants TGA to retain the current opaque system.
TGA is plotting a course between the positions of the branded and generic drugmakers. The agency is set to start posting details of filings for approval of “major innovator prescription” medicines in June. At that stage, TGA will not publish details of generic drug submissions, but the agency wants to make the off-patent sector more transparent, too.
To do so, TGA has begun another consultation. The new consultation proposes either making generic drugmakers notify innovators of a filing if patent protection remains or providing such a notification regardless of the patent situation.
TGA is accepting feedback on the new consultation until 9 June. 
TGA Summary
China’s CDE Shares Draft Advice on Avastin, Herceptin and Xgeva Biosimilars
China’s Center for Drug Evaluation (CDE) has published draft guidance on the clinical development of biosimilar copies of Avastin (bevacizumab), Herceptin (trastuzumab) and Xgeva (denosumab). The flurry of biosimilar documents comes shortly after CDE shared draft guidance for developers of off-patent versions of AbbVie’s Humira (adalimumab).
The newly released documents apply the format of the Humira guidance to Roche’s Avastin and Herceptin and Amgen’s Xgeva. All of the drugs are blockbusters, although the arrival of biosimilar competitors has started to affect sales of some of the products in some markets.
To support companies that want to challenge Amgen and Roche in China, CDE has created guides to how to generate data to show off-patent copies are similar, safe, efficacious and compliant with drug quality standards. The guidelines feature details about the trial designs, study populations and doses companies should use to gather the evidence needed to support approval in China.
CDE is accepting feedback on the drafts for the next month.
Avastin, Herceptin, Xgeva
TGA Deploys Regulatory Toolkit to Meet Rising Demand for Ventilators
The Australian government and TGA have taken further actions to increase the supply of ventilators. Through the changes, the government has exempted ventilators from essential principles, conformity assessment procedures and inclusion in the Australian Register of Therapeutic Goods.
With forecasts suggesting Australia will need 8,000 ventilators to cope with the COVID-19 pandemic, the government has granted emergency exemptions to domestic manufacturers of the devices. The exemptions permit manufacturers to supply Australian healthcare facilities with locally made ventilators that meet certain specifications and testing requirements.
TGA shared the specifications in a separate document that details minimal acceptable performance requirements for ventilators designed for use in managing the COVID-19 outbreak. The document covers similar ground to a text published by the United Kingdom’s medical device regulator last month.
Australian officials shared the specifications the day before publishing guidance on the use of 3D printing to make medical devices for use in the treatment of COVID-19. The guidance explains the steps manufacturers of 3D-printed medical devices need to take to figure out what regulations apply to their products.   
TGA Notice, Ventilator Specification, More
India Opens Fast Track to Industrial Oxygen Suppliers in Response to COVID-19
India’s Central Drugs Standard Control Organization (CDSCO) is trying to make it easier for producers of industrial oxygen to gain clearance to manufacture the gas for medical use. CDSCO enacted the change in light of the effect of the COVID-19 pandemic on demand for supplemental oxygen therapy.
With the number of COVID-19 cases in India nearing 10,000 and currently doubling every six days, there is scope for the outbreak to overwhelm healthcare capacity. Recognizing that, CDSCO is seeking to use its powers to boost the supply of materials that are essential to the care of people with severe symptoms. Medical oxygen is such a material.
To increase supply, CDSCO is offering to grant industrial oxygen manufacturers licenses to produce the gas for medical use within 24 hours of receiving an application and the associated fees.
CDSCO Letter
After Lowering Market Access Barriers, TGA Fast Tracks Recalls of COVID-19 Devices
TGA has created an expedited recall pathway to cut the time it takes to pull COVID-19 devices from the market. The pathway applies to faulty devices and products found to not meet the requirements for receiving exemptions from certain regulations.
To scale up the availability of medical devices needed to counter COVID-19, TGA has loosened the rules covering diagnostics, masks and ventilators. In doing so, TGA has potentially raised the risk that devices that fall short of regulatory requirements will come to market.
TGA responded to that risk by creating the expedited recall pathway. If TGA finds a COVID-19 device should not be on the market, the pathway empowers it to initiate a recall within 24 hours.
TGA Notice
Other News:
TGA has clarified that companies do not need to use GS1 Australia’s Recall Health platform to recall products from the Australian market. The agency first issued a statement to that effect late in 2013. However, according to TGA, there is “continuing confusion in some industry stakeholder groups” about the use of the platform. TGA plans to hold a workshop on the topic when possible. TGA Notice
Malaysia’s Medical Device Authority (MDA) has created a form companies can use to seek permission to deliver, install, test, commission and maintain medical devices at healthcare facilities. The form is needed as, in the absence of exemptions, restrictions on movement imposed in Malaysia in relation to the COVID-19 pandemic prevent those activities from taking place. MDA Notice
China’s National Medical Products Administration (NMPA) has issued guidance on monitoring adverse events related to medical devices. In the guidance, NMPA explains the general requirements for medical device adverse event monitoring systems and the procedures companies should follow. The guidance replaces advices that dates back to 2011. NMPA Statement (Chinese)
TGA has published an overview of COVID-19 antibody tests and their use in Australia. TGA Statement


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