Asia Regulatory Roundup: TGA permits limited unlicensed radiopharmaceutical production

RoundupsRoundups | 12 May 2020 |  By 

Australia’s Therapeutic Goods Administration (TGA) has relaxed the rules on the production of radiopharmaceuticals in response to the breakdown in interstate commerce during the pandemic.
Under normal circumstances, hospitals can readily source radiopharmaceuticals from manufacturers in other Australian states. However, the COVID-19 pandemic has caused a significant reduction in direct flights between state capitals, making it hard for some hospitals to access short-shelf-life radiopharmaceuticals.
TGA responded to the supply constraints by adding radiopharmaceuticals to the list of products that are exempt from some manufacturing requirements. The exemption applies to radiopharmaceuticals made by certain medical practitioners, radiochemists and pharmacists for use within Australia.
Through the change, TGA aims to empower institutions that lack radiopharmaceutical manufacturing licenses to make products for use in other Australian states or territories. Hospitals that can source radiopharmaceuticals from licensed manufacturers should do so.
TGA is advising hospitals not to become reliant on unlicensed manufacturers as a long-term source of radiopharmaceuticals. The TGA advice reflects the belief that the exemption will be reviewed, and potentially withdrawn once travel disruptions abate.  
TGA Notice
Japan grants exceptional approval to Gilead’s remdesivir
The Japanese Ministry of Health, Labour and Welfare (MHLW) has cleared Gilead Sciences’ antiviral remdesivir for use in patients with severe COVID-19. Remdesivir was authorized under an exceptional approval pathway on the strength of Phase 3 data and experience gained from using the drug on a compassionate-use basis.
Researchers presented Phase 3 data on remdesivir on 29 April, providing evidence that the drug is better than placebo and has an acceptable safety profile for the target population. Over the following days, MHLW and the Pharmaceuticals and Medical Devices Agency discussed the evidence, leading to the approval of the drug for use in Japan on 7 May.
The short lag between the presentation of Phase 3 data and approval reflects MHLW’s decision to use an emergency pathway. Under national law, MHLW can approve a drug that is legally available in a country with an equivalent regulatory system to Japan if it could prevent damage from a public health emergency that cannot be managed using existing products. Remdesivir satisfied the conditions once the US Food and Drug Administration granted it emergency use authorization.
To compensate for the relative lack of premarket review, MHLW requires that Gilead implement a risk management plan, including written informed consent and monitoring for all patients.
MHLW wants Gilead to submit the results of additional clinical trials at the “earliest convenience.” The Japanese ministry expects to receive the results within nine months. If remdesivir is seen to be doing more harm than good, or the conditions that enabled its approval by the exceptional pathway change, MHLW can withdraw the authorization.
Gilead is selling remdesivir in Japan under the brand name Veklury.
Press Release, PMDA Statement
China’s CDE seeks feedback on content, format of clinical data submissions
China’s Center for Drug Evaluation (CDE) has released draft guidance on the submission of clinical trial data. The guidance discusses specific content and format requirements intended to standardize how clinical trial data is shared with authorities in China.
Nonstandardized submissions of clinical trial data are harder to review, leading CDE to take steps to help companies make consistent filings. Having engaged with academia and industry last year, CDE has now set out its thinking on the topic in draft guidance. The draft was informed by the approaches of regulators in countries such as Japan and the US.
The CDE document describes a guiding principles framework that can be broken up into five parts. The individual sections address subjects including requirements relating to the format of filings and the traceability of test data.
CDE is accepting feedback on the guidance for one month.
CDE Notice (Chinese)
TGA gives 2 manufacturers more time to comply with breast implant rules
TGA has granted JT Medical and Euro Implants another six months to gain compliance with rules on the safety and quality of breast implants sold in Australia. The extension reflects progress the companies have made since TGA suspended their products late last year.
Responding to concerns about the safety of breast implants, TGA suspended eight products sold by four sponsors in October. In an update last week, TGA said the sponsors of four of the products have chosen to pull their devices from the Australian Register of Therapeutic Goods (ARTG) rather than try to gain compliance. TGA removed a fifth product from the ARTG after the sponsor failed to respond to its request for evidence to support the extension or revocation of the suspension.
Euro Implants and JT Medical did provide evidence “that they are working towards compliance with the requirements,” leading TGA to give them until October to bring their practices in line with its standards. The extension applies to JT Medical’s Sublime Line and 4Two Line, as well as Euro Implants’ Cristaline Paragel Cohesive Gel Implant.
TGA Notice
Malaysia’s MDA resumes some in-person interactions as government eases restrictions
Limited counter service has resumed at the Malaysian Medical Device Authority (MDA) as the national government begun to reopen after a period of lockdown.
Malaysia implemented a movement control order in mid-March, forcing MDA to stop the counter service it uses to support regulatory activities including medical device registration. The order will stay in place until 9 June, but the government wants to start reopening the economy, including the public sector, before then.
People who want to collect medical device registration certificates and other paperwork now can do so. Those using the in-person service to comply with new procedures, including the wearing of face masks.
The counter service will run alongside the remote interactions; companies can continue to access certificates via MeDC@St2.0. MDA is encouraging people to use the online system to make payments but will permit the submission of bank drafts via its counter service.
MDA Notice
Other News:
China’s CDE has published technical guiding principles for controlling nitrosamine impurities in drug products featuring chemically synthesized active pharmaceutical ingredients (APIs). CDE created the text in light of evidence that all chemically synthesized APIs may be susceptible to contamination with carcinogenic nitrosamine impurities. CDE Notice (Chinese)
Australia’s Department of Health has taken steps to ensure enough hydroxychloroquine is available to support approved uses of the drug. Demand for hydroxychloroquine has risen as the drug is investigated as a treatment for COVID-19, raising the prospect of limited access for people who use the drug to manage conditions including lupus. TGA Notice
The Philippine Food and Drug Administration (FDA) has issued a warning to companies that make misleading claims about the ability of their medical devices to cut the risk of coronavirus infection. FDA Advisory


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