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  • Regulatory NewsRegulatory News

    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 ...
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    Industry Group Pitches Changes to Australia’s Regulatory System

    Medicines Australia, a trade group representing members of Australia’s pharmaceutical industry, is proposing a series of reforms to Australia’s regulatory system in the hopes of increasing the speed at which the Therapeutic Goods Administration (TGA) approves new medicines. Independent Review On 24 October 2014 the Australian government announced it would conduct an “independent review of the regulation of medicines and medical devices." The goal of the review will be...
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    Oceania Regulator ANZTPA Shut Down by Australia and New Zealand

    Australian and New Zealand officials have confirmed they plan to stop development of the Australia New Zealand Therapeutics Products Agency ( ANZTPA ), a joint regulatory authority meant to more efficiently regulate healthcare products in both countries. Background The ANZTPA has been under development since at least 2011, and had reached several notable milestones since 2012. In September 2012, it put out a call to  harmonize over-the-counter drug regulations , and  co...
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    Australian Government Orders Review of Drug and Device Regulations

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The Australian government has announced that experts will review the Therapeutic Goods Administration’s (TGA) framework for the regulation of medicines and medical devices. According to a 24 October 2014 announcement by Health Minister Peter Dutton and Assistant Minist...
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    Australia’s TGA Issues Amended Nonclinical Studies Guidance

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued  an amended guidance on nonclinical studies for Module 4 of the  Common Technical Document  (CTD), which is an integral part of an application to register a prescription medicine on...
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    Australian Regulator TGA Undergoing Reorganization

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) has announced (11 September) an internal reorganization as part of broader structural changes within the Department of Health following the Finance Ministry’s call for a " smaller and more rational " government. The D...
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    Australian TGA Taking a More Discerning Approach to Notified Bodies

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits  for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used the...
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    Australian Regulators Lift Ban on HIV Self-Test Kits

    Following a public consultation, Australia’s Therapeutic Goods Administration (TGA) has announced that the Secretary of the Department of Health has lifted the ban on the sale of HIV self-tests. The decision is aligned with the Seventh National HIV Strategy (2014-2017) , which aims to increase detection of HIV in the community by enabling greater access to HIV self-test kits that have been assessed for quality, safety and performance by the TGA. As a result of t...