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  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: UK High Court Rejects Interpretation of EMA Powers

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK High Court Rejects Interpretation of EMA Powers, Opening the Door to Avastin Use in AMD   The High Court in London has ruled that the National Health Service (NHS) can use Roche’s Avastin on an off-label basis to treat wet age-related macular degeneration (AMD). In siding with the NHS over AMD drug developers Bayer and Novartis, the judge stated that organization...
  • 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

    UK Report Calls for Streamlining to Accelerate Access to Drugs by Four Years

    The UK government on Monday released a new report on accelerated access, claiming the UK's National Health Service (NHS) could speed access to new drugs and devices by streamlining regulatory, health technology assessment (HTA) and reimbursement mechanisms. Specifically, the report proposes the development of an "accelerated access pathway" that would help speed up new technologies, including drugs, devices and diagnostics with the potential to provide significant benefi...
  • 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...
  • Regulatory NewsRegulatory News

    UK Patients With NSCLC to get Early Access to Tagrisso

    Patients in the UK with a specific form of non-small-cell lung cancer (NSCLC) will get early access to AstraZeneca's Tagrisso (osimertinib), following a positive opinion by the Medicines and Healthcare products Regulatory Agency (MHRA). Specifically, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC will be able to access Tagrisso under the Early Access to Medicines Scheme (EAMS). EAMS was created to provi...
  • 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

    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

    Leverage Purchasing Power to Save Billions on Medicines and Devices, NHS Urged

    According to an independent report commissioned by the UK's Department of Health, the National Health Service (NHS) could save as much as £5 billion (GBP) per year by 2020 through medicines optimization and leveraging NHS buying power to save on medical devices and consumables. Improving Efficiency Last year, Health Secretary Jeremy Hunt appointed Lord Carter, member of the House of Lords (Labour) to chair the NHS Procurement and Efficiency Board. In his capacity as cha...
  • 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 ...
  • NICE Assuming New Duties, Will Assist NHS With Use of Innovative Medical Devices

    The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), will soon begin to directly assist the National Health Service (NHS) with the use of innovative new devices, such as surgical implants and diagnostic and monitoring devices, that have been green lighted for reimbursement by NICE.  The new role was recommended by the government in 2011 in its report, "Innovation, Health and Wealth," which called for NICE to assume the d...
  • NICE Green Lights IVD for Breast Cancer Diagnosis

    The UK's cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has agreed to recommend the use of an innovative new diagnostic test designed to guide the use of chemotherapy in patients with early breast cancer. Specifically, the recommendation covers the use of Oncotype DX in patients in the early stages of oestrogen receptor positive (ER+), lymph node negative (LN-) and human epidermal growth factor receptor 2 negative (HER2-) breast...
  • UK's NICE Releases Draft Guidance on Diagnosis and Treatment of Hepatitis B

    The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has issued a draft guideline on the  diagnosis and management of chronic hepatitis B in children, young people and adults , explaining that only pegylated interferon and nucleoside or nucleotide analogues have been cleared for use by the National Health Service (NHS). The guideline, released for consultation on 17 January 2013, also noted that although substantial pr...