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  • Regulatory NewsRegulatory News

    TGA gives Pfizer COVID vaccine provisional determination

    Another vaccine against SARS-CoV-2, the virus that causes the novel coronavirus, has received provisional determination from Australia’s Therapeutic Goods Administration (TGA). Pfizer, doing business in Australia as Pfizer Australia Pty Ltd, received the determination on 14 October for its messenger ribonucleic acid (mRNA) COVID-19 vaccine candidate, BNT162b2.   The decision comes after a 9 October decision by TGA to grant provisional determination to AstraZeneca’s rec...
  • RoundupsRoundups

    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 ...
  • Regulatory NewsRegulatory News

    TGA explains how it will handle lapsed conformity assessments due to MDR delays, COVID

    Australia’s Therapeutic Goods Administration (TGA) on Tuesday released guidance explaining its approach to medical device conformity assessment recertification in light of delays in the implementation of the EU Medical Devices Regulation (MDR) and disruptions caused by the COVID-19 pandemic.   “[TGA] is issuing this guidance to inform sponsors … about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits due ...
  • Regulatory NewsRegulatory News

    TGA moves AstraZeneca's vaccine on first step toward approval

    The Australian Therapeutic Good Administration (TGA) has taken the first step toward provisional approval of the vaccine against COVID-19 being developed by AstraZeneca in collaboration with the University of Oxford. The decision was made after reviewing the firm’s clinical trial plan and weighing the threats of the pandemic, said TGA in announcing its decision.   On 9 October, TGA gave AstraZeneca’s recombinant chimpanzee adenovirus vector vaccine, ChAd0x1-S, a prov...
  • Feature ArticlesFeature Articles

    Current Chinese NMPA clinical pathways for medical device registration

    This article presents the key highlights of the current clinical pathways for registering medical devices in China and discusses when the various clinical pathways should be used, based on the country's National Medical Products Administration (NMPA) regulations and guidances. Introduction The NMPA, 1 formerly known as the China Food and Drug Administration, is the Chinese agency responsible for regulating drugs and medical devices. In addition to the national NMPA, ...
  • Regulatory NewsRegulatory News

    Australia and Canada Jointly Approve Breast Cancer Drug

    As part of a push toward regulatory convergence, Health Canada and Australia’s Therapeutic Goods Administration (TGA) last week jointly approved Eli Lilly’s Verzenio (abemaciclib) for the treatment of metastatic breast cancer. Each regulator evaluated different parts of the regulatory submission dossier, although both made independent decisions regarding approval. Health Canada also worked with the Canadian Agency for Drugs and Technologies in Health (CADTH) on the appr...
  • Regulatory NewsRegulatory News

    TGA Proposes 5 Medical Device Classifications in Line With EU MDR

    In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR).  The consultations consider the current classification requirements in Australia for five specific medical device types and either propose new classification rules to be incorporated into the existing Australian medical device regulations or classification changes. Propo...
  • Regulatory NewsRegulatory News

    Transition to ISO 13485:2016 Comes to an End

    The three-year transition period for ISO 13485:2016 officially ended Thursday and as of Friday all ISO 13485:2003 certificates are now null and void, regardless of their original expiration date. The role of the revised standard plays into major regulatory initiatives worldwide aimed at international harmonization. Both the 2003 and the 2016 version of the global consensus standard—developed by the International Organization for Standardization (ISO—co-existed until Thu...
  • Regulatory NewsRegulatory News

    TGA Unveils Guidance on the Regulation of SaMD, Personalized Medical Devices

    Australia’s Therapeutic Good Administration (TGA) released further guidance Wednesday on the regulation of software, including software as a medical device (SaMD), and a separate new guidance to propose a regulatory framework for personalized devices, including 3D-printed devices. The 19-page SaMD document expands on guidance TGA posted last December. The 23-page proposed regulatory scheme for personalized medical devices comes after the agency launched a consultati...
  • Regulatory NewsRegulatory News

    Australia Proposes to Reclassify Spinal Implants in Line With EU MDR

    Australia’s Therapeutic Goods Administration (TGA) opened a consultation on Monday to obtain feedback on its proposal to reclassify all spinal implantable medical devices to a higher risk level. The consultation describes the reasoning behind changing the current Class IIb classification of medium-high risk on spinal implants to Class III under a new classification rule. It comes as part of an effort to align Australia’s regulatory requirements with the new framework of...
  • Regulatory NewsRegulatory News

    Physicians’ Favorable Views of FDA Drug Approval Standards Underscore ‘Disconnect,’ Survey Finds

    A research letter published in JAMA Internal Medicine on Tuesday highlights the “disconnect” between many physicians’ perceptions of the US Food and Drug Administration (FDA) drug approval process and the “current reality.” The findings are based on a survey aimed at gaging physicians’ attitudes toward FDA drug approval standards and off-label promotion, with a total of 686 survey (48% response rate) respondents listed by the American Board of Internal Medicine Diplom...
  • Regulatory NewsRegulatory News

    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 ...