• Regulatory NewsRegulatory News

    UK Industry Group Sees More Complaints Against Pharma Members in 2016

    The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the Association of the British Pharmaceutical Industry's (ABPI) code of practice, says it saw more complaints about drugmakers' promotional materials and activities in 2016 than in the previous year. In 2016, PMCPA saw a 41% jump in the number of complaints it received over 2015, with 76 complaints compared to 54. These complaints led to 100 cases covering 420 individual matters, as many of the...
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    ABPI Extends Astellas UK Suspension for 12 More Months

    The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety." Astellas was originally suspended in June 2016 for deception and was re-audited in September 2016 and April 2017, which "highlighted a lack of oversight and training of agency nurses who delivered patient support programmes, inc...
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    Celgene, Takeda and Others Found in Breach of UK’s Pharma Code of Practice

    When is it OK for a pharmaceutical company to fail to quality check bags stored in a basement for three years before supplying them to pharmacies to use when dispensing the chemotherapy Navelbine (vinorelbine) to patients? Apparently never, according to Tuesday’s rundown of companies breaching the Association of British Pharmaceutical Industry’s (APBI) Code of Practice. In addition to the basement storage fiasco for the French company Pierre Fabre, which the UK’s Pr...
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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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    MHRA Raises Concerns Over Improper Biosimilar Marketing

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday unveiled its misgivings with a two-day promotional meeting for UK health professionals on the Remicade (infliximab) biosimilar Remsima in Norway. The meeting, entitled “Norway inflammatory bowel disease [IBD] exchange,” was intended by the privately held, UK-based Napp Pharmaceuticals to promote Remsima from 11-13 October 2015 for UK healthcare professionals. The meeting was ruled in breach of...
  • UK Organizations Band Together to Form New Clinical Trial Transparency Standards

    • 24 May 2012
    A number of prominent UK healthcare organizations have banded together to form a new set of principles meant to set a new voluntary standard for the reporting of clinical trial data, reports PMLiVE . The coalition of groups, which includes the Association of the British Pharmaceutical Industry (ABPI), the General Medical Council, the Prescription Medicines Code of Practice Authority and The Academy of Medical Royal Colleges, is being called the Ethical Standards in He...