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  • Regulatory NewsRegulatory News

    EU agencies urge sponsors to ensure post-Brexit compliance with clinical trial rules

    In a notice issued on Thursday, the European Commission, European Medicines Agency and Heads of Medicines Agencies reminded clinical trial sponsors that they must comply with EU clinical trial rules following the Brexit transition period that expires on 31 December 2020.   With the deadline to extend the transition period now passed, “There is no possibility for further extension beyond that date,” the agencies write, pointing trial sponsors to the Commission’s Brexit ...
  • Regulatory NewsRegulatory News

    Biopharma industry urges MRA to mitigate risk of no-deal Brexit

    The biopharma industry is urging the European Union to separate talks about post-Brexit regulatory cooperation from broader political negotiations. Groups including the European Federation of Pharmaceutical Industries and Associations (EFPIA) made the plea amid fears the collapse of free trade talks will force a hard split between the United Kingdom and EU regulatory regimes.   In a letter to senior EU officials, the six trade groups call for Brexit negotiators to pr...
  • Regulatory NewsRegulatory News

    MHRA Offers No-Deal Brexit Guidance on Comparator Products for Generic Drug Studies

    As another delay may push back Brexit to the end of January, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday published new guidance on comparator products (CPs) used in bioequivalence (BE), pharmacokinetic (PK) and therapeutic equivalence (TE) studies to support generic drug and other abridged marketing authorization applications following a no-deal Brexit. The guidance explains how it may be possible for an applicant to compare a proposed...
  • RoundupsRoundups

    EU Regulatory Roundup: UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup   The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit.   ...
  • RoundupsRoundups

    EU Regulatory Roundup: Ireland’s HPRA Floats Fee Increases as Brexit Creates Challenges

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland’s HPRA Floats Fee Increases as Brexit Creates Challenges   Ireland’s Health Products Regulatory Authority (HPRA) is planning to introduce new fees and increase existing charges. HPRA framed the fee increases in light of the increasingly challenging environment in which it operates, pointing to Brexit, new medical device rules and an increase in the complexit...
  • Regulatory NewsRegulatory News

    UK Updates on Drug Shortage Plans Ahead of Looming Brexit Deadline

    Although the UK has prepared for drug supply issues ahead of a no-deal Brexit on 31 October, Matt Hancock, UK secretary of state for health and social care, explained recently what still needs to be done. Chief among the issues that need to be dealt with is industry readiness for the new customs procedures under a no-deal Brexit and ensuring that industry registers to access new freight capacity. “The Government is establishing a dedicated trader readiness ‘Support U...
  • Regulatory NewsRegulatory News

    With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports

    As part of efforts to prevent drug shortages ahead of a possible no-deal Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday published a list of 24 medicines that cannot be parallel exported from the UK. The list includes drugs like the hormone therapies estradiol and levonorgestrel, the antiviral oseltamivir, adrenaline, the blood thinner rivaroxaban and the high blood pressure medicine prazosin, among others. The reason why the UK...
  • Regulatory NewsRegulatory News

    MHRA Updates No-Deal Brexit Device Guidance

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday updated its no-deal Brexit guidance for medical devices, adding a new section on the role of the “UK Responsible Person.” According to the guidance, the UK Responsible Person, who must be established in the UK, acts on behalf of a non-UK manufacturer to carry out tasks for the manufacturer, which include registering with the  MHRA  before a device is placed on the UK market. “Only a manu...
  • Regulatory NewsRegulatory News

    UK Warns Again: No-Deal Brexit Could Disrupt Medicine Supplies

    The UK government on Wednesday published a previously sensitive document explaining how a no-deal Brexit beginning on 31 October could strain trade across the English Channel for up to six months. “The reliance of medicines and medical products’ supply chains on the short straits crossing make them particularly vulnerable to severe extended delays; three-quarters of medicines come via the short straits,” the document, first drafted in August and dubbed “Operation Yellow...
  • Regulatory NewsRegulatory News

    No-Deal Brexit: How Medicines and Devices Will be Regulated in the UK

    Although there may be another extension to Brexit day, the prospect for a no-deal Brexit at the end of October still looms large and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday reiterated guidance on what will happen to drug and medical device regulations if such a no-deal path moves forward. On the side of minimal disruption, MHRA notes that transitional legislation will ensure that all currently granted Centrally Authorised Products ...
  • 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...
  • Regulatory NewsRegulatory News

    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...