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    Euro Roundup: UK rejects new agency to redress drug, device harms

    The UK government has rejected a call to establish an independent redress agency. Baroness Cumberlege, a Conservative party member of the House of Lords, called for the government to create the agency after her review of patient safety in the UK identified a need for a new way to remedy harms caused by some medicines and medical devices.   Last year, the Independent Medicines and Medical Devices Safety Review advised the government to set up an independent redress agen...
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    Asia-Pacific Roundup: TGA studying risk classification of circulatory system devices

    The Therapeutic Goods Administration (TGA) is holding a consultation on the definition of “central circulatory system” (CCS) in the Australian medical device regulations. TGA identified concerns about the misalignment of the current definition with the European Union in an earlier consultation.   That earlier consultation, which took place in 2019, sought feedback on proposed changes to the classification of medical devices that come into direct contact with the CCS. A...
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    Euro Roundup: Onslaught of Brexit guidances from MHRA; Swissmedic's adverse event reporting challenges

    MHRA publishes 48 guidance documents on new regulatory regime   The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published 48 guidance documents on the processes that will apply now that the Brexit transition period has ended. Throughout 2020, MHRA published guidance on how drugs and medical devices would be regulated in the UK after Brexit. In the days before and after the transition period ended on 31 December, the agency released a flurry o...
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    Asia-Pacific Roundup: India approves AstraZeneca, Bharat Biotech COVID vaccines

    India has approved COVID-19 vaccines developed by AstraZeneca and Bharat Biotech for restricted emergency use. The clearances position India to embark on a campaign to vaccinate 300 million high-risk people and healthcare workers by early August.   The AstraZeneca and Bharat coronavirus vaccines, both of which are kept in standard refrigerators, will spearhead the vaccination campaign after getting the support of the Subject Expert Committee. Acting on the recommenda...
  • Euro Roundup: MHRA sheds light on pathway to accelerate R&D

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the Innovative Licensing and Access Pathway (ILAP) it is setting up to accelerate time to market. Drug developers that follow the pathway will benefit from more input from MHRA and stakeholders including the National Institute for Health and Care Excellence.   Drug developers can access the pathway as soon as they have nonclinical data on a new chemical entity, biological medici...
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    Asia-Pacific Roundup: TGA seeks feedback on medicinal cannabis reforms

    Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on planned changes to the regulation of the manufacturing, labelling and packing of medicinal cannabis that will more closely align the requirements on imported and domestically produced medicinal cannabis.   Domestic producers of therapeutic goods, including medicinal cannabis, must get a good manufacturing practice (GMP) license and undergo TGA inspection. Overseas producers of most therapeutic go...
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    Euro Roundup: EMA warns ‘large number’ of products still need Brexit-related changes

    A “large number” of centrally authorized products (CAPs) contain UK sites and activities that need to be removed by early next year due to Brexit. Companies have until the end of February to submit the required Type IA variation.   The European Medicines Agency (EMA) identified the continued presence of UK sites and activities on the marketing authorization dossiers of CAPs as an area in which the industry still needs to act on a recent webinar. EMA used the webinar to...
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    Asia-Pacific Roundup: India seeks more data on AstraZeneca COVID vaccine

    India’s Subject Expert Committee (SEC) has asked to see additional data on AstraZeneca’s COVID-19 vaccine before deciding whether to grant emergency use authorization (EUA). The Central Drugs Standard Control Organization (CDSCO) wants to see immunogenicity data from patients in the UK and India and safety data beyond the 14 November cut-off shared with it to date.   Serum Institute of India, which is partnered with AstraZeneca on ADZ1222, a viral vector vaccine, put a...
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    ICH updates focus on patient-focused drug development, nitrosamines

    The International Council for Harmonisation (ICH) has shared an update on its initiatives, revealing recent progress in areas including its position on elemental impurities and the role patients can play in drug development.   ICH met virtually last month in lieu of a face-to-face gathering that was to take place in Greece. At the event, ICH’s second virtual gathering of 2020, the management committee re-elected FDA’s Theresa Mullin for another one-year term as manag...
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    FDA posts final guidance on device-specific performance criteria

    FDA has released three device-specific guidance documents detailing performance criteria in support of its Safety and Performance Based Pathway. The texts cover magnetic resonance (MR) receive-only coils, spinal plating systems and non-spinal metallic bone screws.   Last year, FDA published guidance on the optional Safety and Performance Based Pathway. The text set out the agency’s thinking on a pathway intended to enable companies to show a new product is as safe ...
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    Euro Roundup: Lords tell UK government to protect drug, device regulation in trade bill

    The House of Lords has voted in favor of an amendment intended to stop the UK government from striking trade deals that “undermine or restrict” the country’s ability to “regulate and maintain the quality and safety of medicines and medical devices.”   Politicians began debating the Trade Bill 2019-21, which covers the international agreements the UK hopes to strike after completing its split from the European Union, in March. Throughout that time, opposition politician...
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    Asia-Pacific Roundup: TGA/Access set out evidence requirements for COVID vaccine

    Australia's Therapeutic Goods Administration (TGA) and its international collaborators in the Access Consortium have posted their approach to the regulatory evidence requirements for COVID-19 vaccine approvals. Access is a consortium of regulators from Australia, Canada, Singapore, Switzerland and the UK.   Clinical trials should ideally show vaccines cut the transmission of SARS-CoV-2, including from asymptomatic people, as well as reducing incidence of COVID-19 in va...