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    With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports

    As part of efforts to prevent drug shortages ahead of a possible no-deal Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday published a list of 24 medicines that cannot be parallel exported from the UK. The list includes drugs like the hormone therapies estradiol and levonorgestrel, the antiviral oseltamivir, adrenaline, the blood thinner rivaroxaban and the high blood pressure medicine prazosin, among others. The reason why the UK...
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    EMA Expands Online Portal for Parallel Distribution Submissions

    The European Medicines Agency (EMA) on Monday announced that going forward, parallel distributors will be required to use its recently launched secure online portal, known as Iris, to manage and submit parallel distribution notifications.   Background   Parallel distribution, also known as re-exportation, is a process by which companies in the EU distribute centrally authorized medicines between member states, independent of their marketing authorization holder (...
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    Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says

    Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they? Jeff Shuren, director of CDRH late Monday told attendees of JP Morgan’s annual conference that he thinks fear and a limited amount of CMS staff are two reasons that the parallel review ...
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    FDA, CMS: Second Parallel Review Decision Ever for NGS Test

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test. The test was reviewed under FDA and CMS' parallel review program, and is only the second test to be approved and cleared under the program since its inception in 2011, the first being Exact Sciences' Cologuard colorectal cance...
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    EMA, EUnetHTA Sign Off on Three-Year Work Plan

    The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan. Much of the 2017-2020 work plan builds on previous and ongoing efforts to streamline processes between regulators and health technology assessment (HTA) bodies. "By working together, EMA and EUnetHTA help medicine developers to improve clinical research and become more efficient in...
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    FDA Considers Creating New 'Office of Patient Affairs'

    As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency. The move to create the office would be part of the agency’s efforts to offer “a single, central entry point to the Agency for the patient community,” as well as “triage and navigation services for inbound inqu...
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    EMA Explains How it Supports Article 58 Applications

    The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs). Background First introduced in Regulation (EC) No. 726/2004 in 2004, the Article 58 procedure allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in collaboration ...
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    EMA to Launch Tailored Biosimilar Scientific Advice Pilot

    The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars. The tailored procedure will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available (standard  scientific advice  does not include the assessment of existing data). EMA plans to run the pilot until ...
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    FDA and CMS Parallel Reviews of Devices to Continue

    A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday. The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or t...
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    NICE to Charge up to £282,000 for Each New Drug Assessment

    The UK’s National Institute of Health and Care Excellence (NICE) plans to charge pharmaceutical companies new fees of up to £282,000 for each cost-effectiveness assessment for a new medicine beginning next year. News of the new fees stirred controversy in London’s Sunday Times , and a NICE spokesman emailed Focus on Monday with NICE Chief Executive Sir Andrew Dillon’s response to that story on the fees for technology appraisal and guidance: “Charging pharmaceutica...
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    European Regulatory Roundup: EMA to Waive Some Scientific Advice Fees for Accelerated Access Program (9 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Posts new Guidance on Changing Risk-Management Plans, Manufacturing Sites The European Medicines Agency (EMA) has posted new guidance on post-authorization changes to risk-management plans (RMPs) and manufacturing sites. EMA, which has adopted the policies in an attempt to simplify processes for marketing authorization holders, explained the implications of the guidance...
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    8 Pieces of Advice for New Regulatory Professionals

    The sheer volume of laws, regulations and guidance documents covering medicines and medical technology means new regulatory professionals have a lot to learn. Even those who have regulatory experience may find themselves behind a steep learning curve when taking on new responsibilities or switching jobs. What should new regulatory professionals or those changing product lines or industries do to position themselves for success? David Chadwick, PhD, RAC, FRAPS, who is ...