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    Asia-Pacific Roundup: Singapore seeks feedback on planned unique device identification system

    Singapore’s Health Sciences Authority (HSA) is seeking feedback on the regulatory requirements for the planned implementation of a unique device identification (UDI) system. HSA wants to establish a harmonized identification system to enable the traceability of medical devices.   Today, HSA lacks the means to track the distribution and use of medical devices across the supply chain and healthcare system. HSA wants to gain that power to support the timely identification...
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    Asia-Pacific Roundup: Vietnam seeks mRNA tech transfer for local COVID vaccine production

    The Vietnamese health ministry has met with the World Health Organization (WHO) to discuss the transfer of the technology needed to manufacture mRNA vaccines in the country.   Vietnam received a shipment of 811,200 doses of the COVID-19 vaccine developed by AstraZeneca and the University of Oxford via the COVAX Facility at the start of last month. Around 900,000 people have now received a vaccine, but the supply of doses remains a constraint on the pace of the rollou...
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    Asia-Pacific Roundup: TGA consults on advertising code revamp

    The Therapeutic Goods Administration (TGA) is seeking feedback on ways to improve the Australian Therapeutic Goods Advertising Code and has proposed options for addressing provisions that it has identified as unclear or inconsistent since the current version of the code came into effect two years ago.   In the consultation document, TGA lists multiple issues with the current code that stakeholders have identified, plus options for how to remedy them. For example, some ...
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    Asia-Pacific Roundup: TGA new drug approval times hold steady despite pandemic pressures

    Australian approval times for new drugs and other filings held steady in the second half of 2020 despite the pressures COVID-19 put on regulatory officials, according to a TGA report.   The median approval time for new chemical entities, new biological entities and biosimilars over the back half of last year was 196 days, compared to 198 days in 2019 and a legislated timeframe of 255 days. TGA median approval times for major variations and new generic medicines fell 4%...
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    Asia-Pacific Roundup: Japan’s PMDA shares principles for evaluation of COVID-19 vaccines

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published principles for evaluating COVID-19 vaccines. The principles echo guidelines published in other parts of the world, for example by recommending that studies are designed to show vaccines prevent COVID-19.   PMDA, like its peers, is against the use of surrogate measures given the lack of evidence linking them to the key endpoint of COVID-19 prevention. Clinical trials to assess the preventive effect ...
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    Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivir

    Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Gilead Sciences’ remdesivir for use in adults and adolescents hospitalized with severe COVID-19 symptoms.   Like its international peers, TGA sought to fast track its review of remdesivir to get the antiviral to patients as quickly as possible. TGA said it made a decision within two weeks of receiving a filing for approval of the drug, which is sold under the brand name Veklury, by h...
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    Asia Regulatory Roundup: TGA orders re-evaluation of COVID-19 antibody studies amid false negative concerns

    Australia’s Therapeutic Goods Administration (TGA) has asked the sponsors of point-of-care tests for antibodies against the SARS-CoV-2 coronavirus to re-evaluate their clinical performance studies. TGA made the request after reviewing the findings of a postmarket evaluation carried out by a third party.   The Onsite and VivaDiag tests, which are made by CTK Biotech and VivaChek Biotech, respectively, came to market with instructions for use that quoted sensitivity figu...
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    Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live (16 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Provides Guidance as Black Triangle Adverse Event Scheme Goes Live Australia’s Therapeutic Goods Administration (TGA) has posted guidance on its black triangle adverse event reporting scheme. The scheme came into force at the start of the year, leading TGA to share a guide that addresses some of the uncertainties expressed by industry in advance of the go-live day...
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    Asia Regulatory Roundup: China Posts Guiding Principles on Device Trials (9 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Seeks Feedback on Drug Data Management Practices China is seeking feedback on its draft drug data management practices. The China Food and Drug Administration (CFDA) text details how individuals and organizations involved in the development, production, distribution and monitoring of drugs should ensure the accuracy and traceability of the data they generate. C...
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    Asia Regulatory Roundup: TGA Adopts Guidance on Device Priority Review Pathway (2 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Adopts Guidance on Medical Device Priority Review Pathway Australia’s Therapeutic Goods Administration (TGA) has adopted guidance on its priority review pathway for medical devices. The adoption of the guidance allows developers of highly promising devices aimed at serious unmet needs to jump to the front of the queue when they file for approval. Devices must mee...
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    Asia Regulatory Roundup: TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines (19 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines Australia’s Therapeutic Goods Administration (TGA) has finalized its timelines for reporting adverse events involving biologicals. The timelines are unchanged from draft guidance published last year that was criticized by companies including Pfizer for giving sponsors too little time to act. Un...
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    Asia Regulatory Roundup: Australia, Singapore Expand Generic Drug Work-Sharing Trial (12 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia, Singapore Expand Generic Drug Work-Sharing Trial A regulatory consortium featuring Australia and Singapore has expanded its generic medicine work-sharing program. The initiative allows companies to file for approval with multiple agencies, which then perform a coordinated assessment of the application before reaching individual decisions. Agencies in Aust...