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    TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

    New draft guidance from Australia’s Therapeutic Goods Administration (TGA) encouraged use of regulatory policies that span total product lifecycles (TPLC) to ensure medical device cybersecurity. A “growing area of interest” for TGA relates to “a large number” of class II, class III and active implantable devices registered in Australia that contain “electronic components with embedded software, have a software accessory or are a software device,” the regulator noted in ...
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    TGA Proposes Regulation on IVD Companion Diagnostics

    Australia’s Therapeutic Goods Administration (TGA) issued a consultation paper on Tuesday to propose a new framework for the regulation of companion in vitro diagnostic (IVD) devices. The framework proposes 10 different modifications, subject to ministerial approval, to the current regulation on the assays, otherwise known as IVD companion diagnostics (CDx). TGA argues the modifications are needed to address existing “concerns with the current regulatory model, part...
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    Australia’s TGA to Take Over Regulation of Therapeutic Goods Advertising

    Beginning 1 July 2018, Australia’s Therapeutic Goods Administration (TGA) will be responsible for receiving and considering all complaints about drug and medical device advertisements directed at the public under what it calls "a simplified complaints system." With the intention of addressing the criticisms of the current system from a public consultation on  the regulatory framework for advertising therapeutics  in November 2016, the decision means all complaints...
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    Australia Considers Allowing the Marketing of Devices Approved Overseas

    Australia’s Therapeutic Goods Administration (TGA) on Monday released a proposal to allow for the use of devices that have received marketing approvals from select foreign authorities. TGA says its primary objective in releasing the proposal is to either: Use approvals from comparable overseas regulators as the evidence of regulatory compliance for including devices in the Australian Register of Therapeutic Goods (ARTG) (and to avoid the need for duplicate assessments...
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    Asia Regulatory Roundup: CFDA Offers New Drug, Device Draft Guidance (16 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Shares Flurry of Proposals to Encourage Drug, Medical Device Innovation The China Food and Drug Administration (CFDA) has released four draft documents intended to encourage innovation in the drug and medical device industries. CFDA’s proposals aim to cut the time it takes to set up a clinical study, accelerate the approval process, overhaul the patent system and...
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    TGA to Move Forward With Orphan Drug Revamp

    Australia's pharmaceutical industry is "broadly supportive" of proposed changes to the country's orphan drug program, the Therapeutic Goods Administration (TGA) says. On Tuesday, TGA released feedback it received in response to a 2016 consultation on the proposed changes, which include raising the population threshold for rare diseases, taking the seriousness of the condition into account when making designations and requiring sponsors to demonstrate significant benefit ...
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    Asia Regulatory Roundup: Australia to Adopt 10 EMA Guidelines (4 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia Starts Consultation on Planned Adoption of 10 EMA Guidelines The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on its plan to adopt 10 European Medicines Agency (EMA) guidelines. Most of the documents are replacements for existing EMA texts previously adopted by TGA, but some, such as guidelines on clinical development of drugs agai...
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    Asia Regulatory Roundup: Australia Looks to Establish Expedited Approval Pathway (20 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia Moves Closer to Establishing Expedited Reviews Australia has pushed its expedited review program closer to fruition by accepting the recommendations of an expert panel, which called for the creation of an expedited review pathway and an option to leverage overseas approvals when trying to bring a drug to market in Australia. Lloyd Sansom, Will Delaat and John H...
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    Australia Outlines Major Drug Label Changes

    Australia’s Therapeutic Goods Administration (TGA) on Tuesday announced upcoming changes to the way medicine labels on the island will look and be laid out in order to make more pertinent information about medicines easier to find. The changes, which will be implemented over four years beginning 31 August 2016, will be made available in Australia’s Federal Register of Legislation from 17 August 2016, along with guidance on how to apply the new labeling orders. T...
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    Asia Regulatory Roundup: Serious Injuries Linked to Devices in China Almost Double (31 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Reports Drop in Manufacturers Achieving Satisfactory Compliance Australia’s Therapeutic Goods Administration (TGA) has reported a sharp drop in the proportion of domestic manufacturers achieving satisfactory levels of compliance during inspections. In the second half of 2015, no more than 81% of inspections identified satisfactory levels of compliance, compared to...
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    Asia Regulatory Roundup: India Considers Phasing Out Gelatin-Based Capsules (12 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Seeks Feedback on Proposal to Phase Out Gelatin-Based Capsules The Drug Controller General of India (DCGI) is seeking feedback on a proposal to replace gelatin with cellulose in drug capsules. If enforced, the transition would represent a major change for the capsule manufacturing industry, the output of which is currently dominated by gelatin-based products. DCGI i...
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    Asia Regulatory Roundup: India Looks to Raise Drug Inspection Standards (20 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CDSCO Creates Induction Program to Raise Standards at Inspectorate The Central Drugs Standard Control Organization (CDSCO) has set up an induction program to train assistant drug inspectors. A three-month training program, in which CDSCO will cover the regulatory framework in India and other topics, is the centerpiece of the induction strategy. CDSCO has introduced ...