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    UK’s MHRA Introduces Re-Manufacturing of Single-Use Devices

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that single-use medical devices may be re-manufactured for use in the UK, though the remanufacturers should meet all relevant criteria under the appropriate device directives and place a CE mark on their product. The shift to allow such re-manufacturing comes with new guidance from MHRA, which notes that the re-manufacturing of single-use devices and similar processes have existed outsid...
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    Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators

    The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue. Emer Cooke, head of international affairs at the EMA, said that the Brexit decision, which may cause the agency to leave London, “is a decision that affects a lot of the staff of the agency, p...
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    Brexit Conundrum: How Does MHRA Work With EMA Moving Forward

    With the UK deciding by referendum to leave the EU, the vote will have major implications for the regulation of medicines and medical devices across the entire continent. Not only will the European Medicines Agency (EMA) have to uproot its headquarters from London (presumably shifting more than 600 full-time employees), but the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will have to decide if they want to continue conducting drug manufacturing...
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    European Regulatory Roundup: MHRA, UK Biopharma Industry Warn Against Brexit (12 May 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Chairman Signs Letter Warning of ‘Complexity and Uncertainty’ of Brexit The chairman of the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has signed a letter warning of the “complexity and uncertainty” that could follow Britain’s exit from the European Union (EU). MHRA Chairman Sir Michael Rawlins joined with more than 90 other members of the...
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    European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Backs Plan to Create Database of Off-Label and Experimental Treatments The United Kingdom government has thrown its weight behind legislation that would result in the creation of a database of innovative treatments being carried out by doctors in England, including both off-label uses of existing drugs and tests of unlicensed, experimental therapies. Official...
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    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 ...
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    MHRA, CDSCO Sign Agreement to Increase Regulatory Collaborations

    • 05 October 2015
    As more drugs and active pharmaceutical ingredients (APIs) are manufactured in India, foreign regulators are increasingly looking to strengthen relations with India's Central Drugs Standard Control Organisation (CDSCO). On Monday, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) did just that, signing a Memorandum of Understanding (MOU) with CDSCO, as part of plans to increase collaborations between the two countries to keep medicines and medical devic...
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    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 ...
  • UK Formally Launches Early Access Pathway for Neediest Patients

    The UK's Medicines and Healthcare products Agency (MHRA) has announced that it had formally opened a new regulatory program intended to allow severely ill consumers earlier access to potentially lifesaving medicines. Background The program, known as the Early Access to Medicines Scheme (EAMS), was first announced in March 2014. As described by the UK's Department of Health, EAMS is intended to make the UK "one of the best countries in the world to capitalize on breakthr...
  • Chair of UK’s MHRA Leaving

    Sir Gordon Duff, the chairman of the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced on 27 March 2014 that he is giving up his position at the agency after his recent appointment as Principal of St Hilda's College, Oxford. The move is to take place "later this year" and the Department of Health has already initiated a recruitment process to find a successor for Sir Gordon. Prior to taking the position as chair of the MHRA in January 2013, Sir Go...
  • UK Regulators Release Guidance on Software Apps

    The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has published a new guidance document intended to facilitate the development of medical device stand-alone software-a category which notably includes healthcare "apps" capable of running on smartphones. Background The document, released on 19 March 2014, comes at a time when global regulators have been struggling to regulate the burgeoning field of medical software and apps. The struggle lies between...
  • MHRA Launches its Own 'Breakthrough' Pathway to Allow for Early Access to Some Medicines

    The UK's Medicines and Healthcare Products Agency (MHRA) has announced that it will soon launch a new regulatory program intended to allow severely ill consumers earlier access to potentially lifesaving medicines. The program, known as the Early Access to Medicines Scheme (EAMS), has long been in the works at the regulator, and its launch was previewed last week in British newspaper The Telegraph . As announced on 14 March 2014 by MHRA and the UK Department of Hea...