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  • Regulatory NewsRegulatory News

    MHRA to Land a New Interim Chief Executive Ahead of Brexit

    Beginning 20 September, June Raine will be the new interim Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA). Raine will replace Ian Hudson, who will step down after 18 years with MHRA, including six years as chief executive. In addition to Hudson, John Wilkinson, director of devices at MHRA, will step down at the end of October. In June, Wilkinson discussed with Focus several initiatives that MHRA is working on, including how to de...
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    EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020

    The European Commission (EC) said recently that all marketing authorization holders (MAHs) need to ensure that all work at batch testing facilities in the UK is transferred to EU facilities and that all the necessary regulatory submissions are completed by 1 January 2020. The reminder announcement follows a letter sent last February that said drugmakers under certain circumstances would be allowed to continue batch testing in the UK even after the UK departed from the...
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    RoundupsRoundups

    EU Regulatory Roundup: UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation   Committees of British politicians have pushed back against the government’s attempts to adopt new drug and medical device legislation without holding debates in Parliament.   Last month, the UK government proposed changes to legislation intended to ensure the rules covering dru...
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    EC Explains Brexit’s Impact on GLP

    Beginning 1 November, the UK will likely not be a member of the EU. As that date approaches, the European Commission has outlined the consequences of how EU rules in the field of Good Laboratory Practice (GLP) will no longer apply to the UK, although an EU-wide “Mutual Acceptance of Data” (MAD) system will apply. The MAD system, established under the Organisation for Economic Co-operation and Development (OECD), will apply as of the UK’s withdrawal date, and all member ...
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    EU Regulatory Roundup: Trade Group Warns Preparing UK for October No-Deal Brexit is ‘Impossible’

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Trade Group Warns Preparing UK for October No-Deal Brexit is ‘Impossible’   A biopharma trade group has warned it will be “impossible” to prepare the UK medicine supply chain to withstand the impact of a no-deal Brexit by October. The warning comes as the leading candidate to take over as Prime Minister committed to take the UK out of the EU on 31 October, “do or di...
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    RAPS AnnouncementsRAPS Announcements

    MDR, IVDR and ‘Navigating the Grey’ Key Topics at RAPS Regulatory Conference Europe Opening

    The RAPS Regulatory Conference Europe 2019 kicked off in Brussels Monday with a lively discussion among expert panelists representing European health authorities, notified bodies, and industry groups as well as other regulatory professionals including RAPS members from around the world. The EU’s transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) was a key point of discussion as multiple panelists expressed concern about the ti...
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    Swiss Medtech Group Warns of What’s to Come Without Updated EU MRA

    Switzerland’s medical technology lobbying group issued recommendations to manufacturers Thursday to prepare for different possible regulatory scenarios because of uncertainty with the Institutional Agreement between the EU and Switzerland (InstA). Stalling the InstA “directly affects the medical technology sector,” said Swiss Medtech. The group noted challenges with not knowing whether support for the InstA will be voiced and whether Switzerland and the EU’s Mutual Reco...
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    RAPS AnnouncementsRAPS Announcements

    European and UK Health Authority Officials, Industry Leaders, Notified Body Reps, Other Experts to Speak at RAPS’ Europe Conference

    RAPS released the updated agenda for its upcoming European conference in Brussels, 13–14 May. Among the speakers for the inaugural RAPS Regulatory Conference – Europe 2019 are representatives from the European authorities, notified bodies and trade representatives, all thought leaders and stakeholders with crucial responsibilities in the effective implementation and functioning of the changing European regulatory environment. “Europe’s regulatory environment for med...
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    MedTech Europe Flags MDR/IVDR ‘Burning Points’

    Notified body (NB) availability and readiness for implementation of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) stand out among “burning points” in need of authorities’ attention, according to industry group MedTech Europe. The group’s director of regulations and industrial policy, Oliver Bisazza, explained how time is running out on MDR/IVDR implementation, and not just because of the 2020/2022 deadlines, but also due to lack of progress an...
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    EMA Tells Pharma Companies to Continue to Prep for UK’s Withdrawal

    With an extension in place that will push the UK's withdrawal from the EU back to either April or May, the European Medicines Agency (EMA) told pharmaceutical companies on Monday to continue their preparations for Brexit. Under the European Council decision from last Friday, if the withdrawal agreement between the UK and the EU is approved by the UK House of Commons by 29 March 2019, the extension will be until 22 May 2019. But if the withdrawal agreement is not approve...
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    EMA on Brexit: Risk for Drug Shortages Decreases

    As the UK and EU agreed to extend the Brexit deadline, the European Medicines Agency’s (EMA) Management Board said following its first meeting in Amsterdam that the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”   The board said the risk has gone down because more companies have taken the necessary steps to ensure that their medicines can remain on the market. EMA last September said the number of centrally authorized me...
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    Asia Regulatory Roundup: Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository   Singapore’s Health Sciences Authority (HSA) has apologized to blood donors after a vendor stored their information in a vulnerable database. HSA learned the database lacked adequate safeguards from a cybersecurity expert and does not think other unauthorized people accessed the information...