The RAPS website will be under maintenance starting at 5 pm Eastern on Friday, October 1, 2021 until 8 am on Monday, October 4, 2021.
Portions of the website may be inaccessible during this time. We apologize for any inconvenience.

  • RoundupsRoundups

    Euro Roundup: UK sets up group to involve patients in ILAP pathway

    UK sets up group to involve patients in Innovative Licensing and Access Pathway   The UK Medicines and Healthcare products Regulatory Agency (MHRA) has formed a patient group to support its Innovative Licensing and Access Pathway (ILAP). MHRA set up the group to ensure that “patient views are an integral part of the ILAP ambition.”   UK officials shared details of ILAP late last year, describing how the pathway will accelerate time to market by enabling drug de...
  • RoundupsRoundups

    Euro Roundup: UK’s NICE launches five-year strategy

    The UK’s National Institute for Health and Care Excellence (NICE) on Monday announced a five-year strategy to revamp its approach to health technology assessments (HTA) to speed access to new and innovative treatments.   “The new strategy sets out a vision for the future where NICE will be more dynamic, work more collaboratively, and continue to build on the excellent foundations of the last 22 years,” said NICE Chief Executive Gillian Leng.   The strategy is built...
  • Regulatory NewsRegulatory News

    England and Canada diverge from US on cancer drug decisions

    Regulatory and health technology assessment agencies in Canada and England are diverging from the US when it comes to oncology drugs. But they often rely on the same surrogate endpoints to make their decisions, according to two new analyses published in JAMA Internal Medicine .   The first study , led by Avi Cherla, MSc, of the London School of Economics and Political Science, revealed that among 68 cancer indications with accelerated approval in the US that also rec...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...