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  • RoundupsRoundups

    EU Regulatory Roundup: ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work   The European Parliament’s health committee has renewed its call for the region’s drug regulator to be given more money and staff. ENVI, the Committee on the Environment, Public Health and Food Safety, made the comment in its opinion about the European Union’s 2020 budget proposal.   Pascal Ca...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Explains its Regulatory System (14 September 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Gathers Global Drug Agencies, NGOs to Explain its Regulatory System The European Medicines Agency (EMA) is meeting with medicine agencies and non-governmental organizations (NGOs) to explain its regulatory system. EMA sees the education initiative helping other global regulators understand its system and, by extension, more effectively collaborate with its staff. ...
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    European Regulatory Roundup: ENVI Urges EC to Exclude Healthcare From Regulation of Professions (15 June 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. ENVI Urges Commission to Exclude Healthcare From Regulation of Professions A public health committee has urged the European Commission to exclude healthcare jobs from changes to the regulation of professions. The Committee on the Environment, Public Health and Food Safety (ENVI) is worried the proposed legislation is “too complex to implement” and involves “too much re...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Merck Accused of Blocking Remicade Biosimilars (25 May 2017)

    Welcome to our European Regulatory Roundup, a weekly overview of top EU regulatory news. Merck Accused of Blocking Remicade Biosimilars, Using Abusive Discount Scheme The UK’s competition watchdog has accused Merck of running an abusive discount scheme to defend Remicade against biosimilar competition. Merck has a chance to respond to the provisional decision before the watchdog rules whether it has violated competition law and faces a fine. Officials at the Co...
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    European Regulatory Roundup: ENVI Calls to for EMA Budget Reserves in Case of Brexit Volatility (9 February 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. ENVI Calls for EMA to Maintain Budgetary Reserve to Mitigate Brexit Volatility A public health committee has called for officials to clear the European Medicines Agency (EMA) to maintain a budgetary reserve for use in the event of Brexit-related volatility. The committee thinks such a reserve is needed if EMA is to cope with the unforeseen costs and unfavorable exchange...
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    EU Parliament Committee Backs Report to Increase Access to Medicines

    The European Parliament’s Environment, Public Health and Food Safety (ENVI) committee on Tuesday backed a draft report calling on the commission to analyze the impact of intellectual property on pharmaceutical access, as well as review the regulatory framework for orphan medicines, among other provisions. The draft , which a spokeswoman for the European Parliament told Focus that a final version will be made public by the end of this week, covers a menagerie of differ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Report Calls to Minimize Amount of Data Generated by Sponsors (28 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Report Calls on Regulators, HTAs to Minimize Sponsor Data-Generation Requirements The European Parliament’s policy department has published a report recommending regulators and health technology assessment (HTA) bodies take steps to minimize the amount of data demanded of drug developers. Members of the Directorate for Economic and Scientific Policies made the proposal in...
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    European Regulatory Roundup: Brexit Could Lead to New Regulatory Burdens (25 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Industry Leaders Warn Brexit Would Lead to Significant Regulatory Burdens More than 50 leaders of the British biopharmaceutical industry have warned of the regulatory and business upheaval that could result from the United Kingdom leaving the European Union, an event dubbed “Brexit.” In a letter in The Financial Times , the executives argue leaving the EU would result in “s...
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    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...
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    EU Considers Major Revisions to Veterinary Medicines Regulations

    The European Parliament is considering major changes to how veterinary medical products are regulated in the EU. At the upcoming meeting of the Environment, Public Health and Food Safety (ENVI) committee on 18 March 2015, members will discuss a proposal for a new regulation which is intended to overhaul the regulation of veterinary medicines and streamline the European market for veterinary medicinal products. Background Veterinary and human medicines regulations in th...
  • European Parliament Proposes Changes to Pharmacovigilance User Fee Collection System

    • 23 October 2013
    A new legislative draft report posted by the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) on 18 October 2013 calls for changes to be made to the way in which user fees are payable to the European Medicines Agency (EMA) for some application filings. EMA, like the US Food and Drug Administration (FDA), partially funds its review work through user fees payable to the agency for many routine activities, such as the registratio...
  • Industry Group: EU Device Regulatory Proposals Would Cost 'Outrageous' €25 Billion

    • 12 September 2013
    With EU legislators now moving ahead with plans to implement a premarket regulatory approval system for medical devices run by the European Medicines Agency (EMA), some in the device industry are beginning to express their fears-loudly-that the proposed changes would stifle innovation in the sector and harm patients by delaying product access. Background Earlier in 2013, the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) release...