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  • Regulatory NewsRegulatory News

    EU Device Industry Groups Call to Accelerate MDR Implementation

    With the EU’s new medical device regulation (MDR) coming into effect in less than a year, seven EU-based medical device industry groups on Wednesday called to accelerate the implementation of the regulation “to avoid severe disruption of product supply to patients and hospitals.” While acknowledging a mechanism in MDR to allow for a grace period for certain devices that must meet the 26 May 2020 deadline, the groups explain why that mechanism has two fundamental weaknes...
  • Regulatory NewsRegulatory News

    New Law to Boost EU-level Cooperation on Health Tech Assessments

    In a boost for health technology assessments (HTA), the European Parliament recently adopted a new law that allows for greater cooperation among EU member states.   The law on HTAs specifically seeks to minimize duplicate assessments on new medicines and medical devices with the goal of removing unnecessary barriers to patient access and reducing administrative burden on industry. Following its 3 October adoption , the law was well-received by MedTech Europe as ...
  • Regulatory NewsRegulatory News

    New E&Y MedTech Report Highlights Growth, Regulatory Questions

    Ernst & Young on Monday released a new report on how the global medical technology (medtech) industry grew by 5% in 2016, with US and EU medtech companies seeing net income increase 17%, though several regulatory and legislative question marks are on the horizon. In addition to the improvements seen in income and revenue growth in 2016 when compared to 2015, the report also shows that overall, US and European medtech financing increased 101% in 2016, to $43.9 billi...
  • RAPS' LatestRAPS' Latest

    RAPS Switzerland Chapter to Host 2015 EU Medtech Reimbursement Roundtable

    No healthcare product, no matter how innovative or essential, will make it to patients without regulatory approval. Every regulatory professional knows this. But there is another critically important factor involved in getting treatments to patients that you may not know as much about—a concept known as market access. The elements of market access include reimbursement and the evidence necessary to secure it from payers, pricing and coverage policy. These areas ...
  • Study: Less Affluent Less Likely to Participate in Clinical Trials

    • 05 June 2012
    A study presented at the American Society of Clinical Oncology (ASCO) 2012 meeting in Chicago finds there is a strong positive correlation between the amount of money a patient makes and how likely they are to participate in a clinical trial for an oncology product. The study of 5,499 patients included those newly diagnosed with breast, prostate, lung or colorectal cancers, of which 9% ultimately participated in a clinical trial. Cost, concluded the study's authors, was ...
  • PLoS: Pressures on Doha Declaration Signatories Preventing Overuse of Compulsory Licenses

    • 12 January 2012
    A recent study in the Public Library of Science's (PLoS) Medicine journal provides a review of the Doha Declaration , and finds that the issuance of compulsory licenses (CLs) dropped significantly after 2006, and that upper-middle-income countries (UMICs) face barriers to utilizing CL's excessively. Compulsory licenses are used by countries to override patents when the country deems that a health crisis warrants such action. When the Doha Declaration was first sig...