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  • RoundupsRoundups

    EU Regulatory Roundup: Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply   Ireland’s Health Products Regulatory Authority (HPRA) has shared details of its work to mitigate the risk that a no-deal Brexit will disrupt the supply of medical devices. HPRA wants companies to consider their stocking levels and make arrangements to ensure they can replenish their supp...
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    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: Swissmedic Proposes Overhaul of Drug Ordinances (29 June 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Proposes Overhaul of Drug Ordinances to Simplify Authorizations The Swiss Agency for Therapeutic Products (Swissmedic) is rewriting its ordinances to simplify the authorization of drugs in certain situations. Swissmedic embarked on the comprehensive overhaul of the regulations in response to changes to the Therapeutic Products Act that were finalized last ye...
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    European Regulatory Roundup: Dutch MEB Raises Concerns About use of ADHD Drug Ritalin in Adults (27 April 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. CVMP Adopts Guideline Despite Criticisms of Rising Regulatory Burden The Committee for Medicinal Products for Veterinary Use (CVMP) has adopted a guideline on the data needed to win approval for immunological minor use, minor species (MUMS) drugs. CVMP is pushing ahead with the guideline despite the animal medicine industry raising concerns it will add to regulatory bu...
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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: MHRA Phasing Out Use of CDs, DVDs in Submissions (30 November 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA to Stop Accepting Submissions on Physical Media in February The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is to stop accepting submissions for medicines licenses on physical media on 1 February 2016. MHRA has decided to drop support for physical media after talking to trade groups about the use of the format. Having completed the...
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    European Regulatory Roundup: EMA Unveils Antimicrobial Strategy (19 November 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Releases Five-Year Antimicrobial Strategy The European Medicines Agency (EMA) has released a document outlining how it plans to ensure the availability of effective antimicrobials for animals while minimizing the risks their use poses to humans. EMA is proposing to restrict the administration of certain antimicrobials to humans. Over the course of the 16-page doc...
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    European Regulatory Roundup: CHMP Updates Breast Cancer Guidelines (15 October 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Updates Data Quality Control, IT Papers as Introduction of New Process Nears The European Medicines Agency (EMA) has updated documents on data quality control and electronic filings ahead of the introduction of a new process in November. EMA will start using the new process on 4 November, at which time the regulator will start sending out alerts every time it vali...
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    EU Committee Takes on Adverse Event Reporting for Veterinary Drugs

    Regulators at the European Medicines Agency (EMA) are concerned that adverse events may be underreported for veterinary drugs. In an effort to address the issue, the agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a reflection paper intended to boost adverse event reporting. Background EMA, along with national regulators, is tasked with monitoring and collecting post-market surveillance data on veterinary medicines. This is done prima...
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    EMA Touts Big Year for Veterinary Products

    The European Medicines Agency (EMA) recommended 20 new veterinary medicines for approval in 2014, the highest number in the past five years, according to data provided by the regulator. The agency also boasts that it received 29 requests for classification of medicines intended for rare diseases or species with a small population, the most the agency has seen in a single year. Addressing Rare Diseases in Animals In 2009, EMA’s Committee for Medicinal Products for Vete...
  • EMA Shines a Light into its Black Boxes of Regulatory: Its Review Committee Meetings

    US regulatory professionals have long benefited from meeting transcripts and other open meeting requirements that have meant that the inner workings and decisions of the US Food and Drug Administration's (FDA) various advisory committees are available for debate and dissection. Background This can be extremely useful for a range of stakeholders. Regulatory professionals seeking approval for similar products can tailor their applications to address the needs of committee...
  • EMA Announces Huge Overhaul of Operations, Processes

    The European Medicines Agency (EMA) is preparing to reorganize its operations, processes and offices in 2013, it has announced. In a statement released on its website on 19 December 2012, the agency said the overhaul will be "focused on increasing the efficiency of its scientific activities and information- and communication-technology operations." A particular focus will be placed on how it supports the mission of its scientific committees-the Committee for Medicinal P...