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  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: UK Sets up Logistics Hub in Belgium to Support Post-Brexit Drug Shipments

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Sets up Logistics Hub in Belgium to Support Post-Brexit Drug Shipments   The United Kingdom has created a logistics hub and bought tickets from ferry operators to mitigate the risk that a no-deal Brexit will disrupt the supply of drugs and medical devices.   In the event of a no-deal Brexit, preferred shipping routes between Dover, Calais and other towns and ...
  • Feature ArticlesFeature Articles

    England Reimbursement Profile

    This profile summarizes the reimbursement process in England, presents key stakeholders and highlights what should be considered early in the development process. Obtaining regulatory approval for medicines is the first major hurdle for most pharmaceutical and biotechnology companies looking to launch their products worldwide. However, obtaining market access once products are approved by regulatory agencies (e.g., MHRA) is a separate and crucial process without which ...
  • Regulatory NewsRegulatory News

    NICE, Roche Reach Deal on Breast Cancer Drug

    Patients in the UK could soon get access to Roche's targeted breast cancer drug Kadcyla (trastuzumab emtansine) through the National Health Service (NHS) as early as next month, the National Institute for Health and Care Excellence (NICE) said on Thursday. Currently, the UK pays for Kadcyla through its Cancer Drugs Fund, which requires patients to apply for funding to get access. The announcement comes just six months after NICE issued its second draft guidance rejecti...
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    UK's NICE to Launch New Online Tool for Med Tech Developers

    • 31 May 2017
    The UK's National Institute for Health and Care Excellence (NICE), which determines if the UK can afford to pay for certain medical treatments, will launch a new online tool in July to help developers of medical devices and diagnostics understand how to generate the evidence necessary to show their products are clinically and cost effective. The Medtech Early Technical Assessment (META) tool, developed in partnership with NICE's Scientific Advice service and the Gre...
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    European Regulatory Roundup: UK to Seek ‘Closest Possible Regulatory Equivalence’ With EMA Post-Brexit (26 January 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK to Seek ‘Closest Possible Regulatory Equivalence’ With EMA Post-Brexit UK Health Secretary Jeremy Hunt has called for the country to seek the “closest possible regulatory equivalence” with the European Medicines Agency (EMA) after Brexit. Exactly what this means will depend on the outcome of upcoming negotiations, but Hunt is open to the UK automatically licensing d...
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    NICE Halts Plans to Charge for Appraisals

    The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy. The controversial plan to charge for appraisals, first unveiled in October , would see companies pay fees of up to £282,000 for each cost-effectiveness assessment. NICE’s chief executive, Sir Andrew Dillon, said...
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    NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage

    The UK’s National Institute for Health and Care Excellence (NICE) on Wednesday announced that it would participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help speed patients’ access to the best new medical devices, diagnostics and other health-related technologies. FDA’s Center for Devices & Radiological Health (CDRH) initially established the PCTF to facilitate communication between device manufacturers and payers to pot...
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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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    NICE Backs Five New Drugs, Gives Conditional Recommendation to GSK's Benlysta

    The UK's National Institute for Health and Care Excellence (NICE) on Wednesday issued recommendations for six drugs after agreeing to discounts with their respective manufacturers, clearing the drugs for use by the country's National Health Service (NHS). The drugs include two cancer drugs from Novartis, Zykadia (ceritinib) and Mekinist (trametinib); two PCSK9 inhibitors, Sanofi's Praluent (alirocumab) and Amgen's Repatha (evolucumab); AbbVie's Humira (adalimumab); and G...
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    European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Proposes Major Changes to Pharmacovigilance Risk Management System Guidelines The European Medicines Agency (EMA) has proposed major changes to its good pharmacovigilance practices (GVP) module on risk management systems. EMA wants to implement the modifications to bring the guidelines in line with its current thinking, which has evolved over the past three years as it ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. NICE Takes Sides in Fight for PCSK9 Market, Recommending Amgen While Rejecting Sanofi The National Institute of Health and Care Excellence (NICE) has recommended using Amgen’s PCSK9 inhibitor Repatha in certain indications, while rejecting the use of Sanofi and Regeneron’s rival drug Praluent. While both manufacturers offered discounts of undisclosed magnitudes, only A...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Looks to Harmonize Definition of Drug Shortage (28 January 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Calls for Harmonized Definition of Medicine Shortages Following Industry Consultation The European Medicines Agency (EMA) has called for the establishment of a harmonized definition of a medicine shortage after meeting with the industry to discuss the development of proactive approaches to preventing shortages in supply. Officials at EMA left the meeting with a strong b...