The main RAPS website will offline for several minutes at 5 PM on 22 October 2021 due to scheduled maintenance.
We apologize for any inconvenience during this time.

  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Looks to Further Prevent Medication Errors (3 December 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Adopts Batch of Documents Aimed at Preventing Medication Errors The European Medicines Agency (EMA) has adopted a handful of guidance documents designed to prevent the occurrence of medication errors. In the documents, EMA outlines the best practices for minimizing risk, how to code and assess errors and specific concerns relating to insulin and other diabetes medicin...
  • Regulatory NewsRegulatory News

    UK Agencies Look to Overhaul Cancer Drugs Fund

    The National Health Service (NHS) of England and the National Institute for Health and Care Excellence (NICE) on Thursday introduced a new proposal to transform the £340 million ($520 million) Cancer Drugs Fund (CDF) to allow patients to have earlier access to new treatments while real-world evidence is still being collected. As many in the UK, like the US, are distraught over the rise of cancer drug prices, NICE and NHS are proposing to turn the CDF, beginning in April ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Unveils Antimicrobial Strategy (19 November 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Releases Five-Year Antimicrobial Strategy The European Medicines Agency (EMA) has released a document outlining how it plans to ensure the availability of effective antimicrobials for animals while minimizing the risks their use poses to humans. EMA is proposing to restrict the administration of certain antimicrobials to humans. Over the course of the 16-page doc...
  • Regulatory NewsRegulatory News

    NICE to Work Earlier With Industry to Speed NHS Adoption of New Drugs, Devices

    The UK's National Institute for Health and Care Excellence (NICE) on Tuesday officially launched its Office for Market Access (OMA) to collaborate more closely with industry to accelerate the adoption of new drugs, devices and diagnostics by the National Health Service (NHS). Specifically, OMA will give commercial stakeholders access to a dedicated team at NICE that they can approach for inquiries relating to health technology evaluation, as NICE is responsible for...
  • Regulatory NewsRegulatory News

    UK to Launch New Office for Market Access

    The UK's National Institute for Health and Care Excellence (NICE) is launching a new office to promote market access for innovative products through early engagement with companies. A proposal and outline for the Office for Market Access (OMA) was approved by NICE's Board of Directors on 20 May 2015. Background When a new medicine is approved in the UK, NICE is responsible for conducting a health technology assessment (HTA) to measure its cost-effectiveness and determ...
  • Regulatory NewsRegulatory News

    NICE Urges Review of Drug Evaluation Methodology

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Following public criticism of its rejection of a number of expensive cancer treatments, the UK’s health cost watchdog is calling for a review of the way new medicines are adopted by the National Health Service.  In a statement released today, the National Institute for ...
  • Regulatory NewsRegulatory News

    UK's NICE Rejects Roche's Breast Cancer Drug Kadcyla, Citing Major Cost Concerns

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance confirming its earlier rejection of Roche’s breast cancer drug treatment Kadcyla for National Health Service (NHS) coverage. Kadcyla (trastuzumab emtansine) treats women with m...