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  • Regulatory NewsRegulatory News

    March 2019: EMA Updates Guidance on Brexit

    The European Medicines Agency (EMA) and the European Commission on Friday updated guidance for pharmaceutical companies on the UK’s departure from the EU, much of which hinges on March 2019 deadlines. For instance, the guidance notes, “Generic/hybrid applications for which marketing authorisations will be granted after 29 March 2019 should refer to a RefMP [reference product] that is or has been authorised in a EU-27 Member State or a contracting state of the EEA [...
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    European Regulatory Roundup: EMA’s Rent Bill at €448M (30 November 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. New Calculation Puts EMA’s Ongoing London Rent Bill at €448M The European Medicines Agency (EMA) faces a €448 million ($531 million) bill for the remaining years on its London rental contract. That new calculation of the cost of EMA’s failure to put a break clause into the contract is notably more than the €348 million estimate suggested by the European Parliament earl...
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    EMA Offers Guidance on Post-Brexit Changes as Industry Groups Call for Transition Period

    The European Medicines Agency (EMA) on Tuesday outlined the requirements that companies should follow when they apply for changes to their marketing authorization to allow for the continued marketing of their medicine in the European Economic Area (EEA) after the UK withdraws from the EU. The guidance, which comes in the form of nine questions and answers and anticipates that the UK will leave the EU as of 30 March 2019, was released on the same day that EU pharma...
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    European Regulatory Roundup: Rise of Cell Therapies Prompts EC to Float Orphan Drug Changes (2 November 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Rise of Cell Therapies Prompts Commission to Float Changes to Orphan Drug Rules The European Commission has proposed changes to its orphan drug regulation. Officials want to make changes to the 17-year-old text to account for the rise of cell therapies and other advanced medicinal products, the nature of which are a poor fit for aspects of the existing regulation. If t...
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    European Regulatory Roundup: UK Prime Minister Hints at Desire to Remain Part of EMA During Brexit Transition (26 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Prime Minister May Hints at Desire for UK to Remain Part of EMA During Brexit Transition Period Prime Minister Theresa May has implied the UK will stay in the European regulatory network during the anticipated Brexit transition period. Delaying the date on which the UK cuts its ties to the European Medicines Agency (EMA) would give businesses and regulators more time to...
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    European Regulatory Roundup: MHRA Chief Floats Faster Reviews, Closer Ties to NICE (19 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Chief Floats Faster Reviews, Closer Ties to NICE as Post-Brexit Options for UK The head of the United Kingdom’s regulatory agency has sketched out some of the ways it may change after Brexit. Dr Ian Hudson stressed the UK wants a collaborative, ongoing relationship with the European Medicines Agency (EMA) but is preparing for the opportunities — and risks — that w...
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    EMA Plots Out Priorities to Deal With Brexit Uncertainties

    The European Medicines Agency (EMA) on Monday released its Brexit Preparedness Business Continuity Plan, saying it will prioritize its core scientific activities, including urgent and significant public health threats relating to the safety and quality of medicinal products for human and veterinary use in the EU. EMA said it's planning a phased implementation of the continuity plan, and in its first phase it will temporarily suspend or reduce lower priority activiti...
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    European Regulatory Roundup: Brexit Sparks Hiring Drive at Danish Medicines Agency (12 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Brexit Sparks Hiring Drive at Danish Medicines Agency The Danish Medicines Agency (DKMA) has become the latest organization to increase its hiring in response to Brexit. DKMA is taking on extra staff at its Medical Evaluation and Biostatistics (MEB) unit to bolster the new department’s ability to help the European Medicines Agency (EMA). As it stands, the department em...
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    EMA Preps for Staff Shortages, Possible 'Major' Budget Deficit

    Although the new European Medicines Agency's (EMA) location will not be known until November, EMA on Friday said again that it's anticipating heavy staff losses which will not only challenge its operability but "could also result in a major deficit in its budget," according to highlights published Friday from a management board meeting this month. The comments follow the agency saying last week that it could lose between 19% and 94% of its staff depending on whic...
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    EMA Warns of Major Staff Losses in HQ Relocation

    The European Medicines Agency (EMA) on Tuesday warned that it could lose a majority of its staff based on which of the 19 cities vying to host the medicines regulator is selected by the European Council in November. Based on the results of a survey completed by 92% of EMA's staff earlier this month, the agency says it could lose between 19% and 94% of its staff depending on which city is selected as its future host. "For certain locations staff retention rates could be ...
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    European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Medtech Industry Pressures Brexit Negotiators to Maintain Existing UK-EU Relationship Leaders from three medical device trade groups have called for the UK to retain close ties to the EU after Brexit. The letter asks negotiators on both sides of the Brexit process to keep the UK in the CE-marking regime and for its national regulatory agency to formally take part in...
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    European Regulatory Roundup: EU Committee Slams Plan to Cut EMA Staffing Ahead of Brexit (7 September 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Committee Slams Plan to Cut EMA Staffing as Agency Prepares for Brexit A health committee has criticized plans to cut staffing levels at the European Medicines Agency (EMA) next year. The Committee on the Environment, Public Health and Food Safety (ENVI) said it “strongly disapproves” of the European Union’s proposal to reduce the number of EMA positions authorized ...