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  • Regulatory NewsRegulatory News

    MHRA issues post-transition orphan, Northern Ireland supply guidance

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued post-transition guidance on orphan medicines designations and incentives, as well as guidance on supplying medicines from Great Britain to Northern Ireland.   The guidances are the latest in a suite of post-transition guidance from the agency as it prepares for the Brexit transition period to expire at the end of the year. (RELATED: MHRA posts suite of post-transition guidances , ...
  • RoundupsRoundups

    Euro Roundup: UK, EU trade groups push Brexit negotiators to act to stop supply disruption

    Trade bodies representing the UK and European Union pharmaceutical industries have urged Brexit negotiators to act now to prevent disruption to the supply of medicines. The joint statement warns failing to form a mutual recognition agreement to soften a hard Brexit could cost both sides billions and delay the supply of medicines by up to six weeks.   The latest round of negotiations about the post-Brexit relationship between the UK and EU is due to end on Friday. If su...
  • Regulatory NewsRegulatory News

    Pharmacovigilance and QPPV: Post-transition guidance from MHRA

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this week issued guidance detailing post-transition pharmacovigilance procedures and requirements for having a qualified person responsible for pharmacovigilance (QPPV) and a pharmacovigilance system master file (PSMF) for UK authorized products.   Pharmacovigilance   MHRA says it “will retain responsibility for pharmacovigilance across the UK from 1 January 2021,” but notes that there will be di...
  • Regulatory NewsRegulatory News

    MHRA: Post-transition guidance on licensing medicines

    In its suite of post-transition guidances released Tuesday, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021.   The guidance, which largely mirrors the “no deal” scenario laid out in now-withdrawn guidance issued last year, explains a range of issues from converting centrally authorized products (CAPs) to UK marketing au...
  • Regulatory NewsRegulatory News

    MHRA posts suite of post-transition guidances

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical trials and more will be regulated after the Brexit transition period expires on 1 January 2021.   Clinical trials   Two guidances related to clinical trials explain requirements for the registration of clinical trials for investigational medicinal products and the submission of substantial ...
  • Regulatory NewsRegulatory News

    UK grants early access to remdesivir for COVID-19

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued a positive early access to medicines scheme (EAMS) opinion for Gilead Sciences’ remdesivir to provide the drug via the National Health Service to certain hospitalized patients with severe cases of coronavirus disease (COVID-19).   “For the time being and due to limited supplies, treatment will be prioritised for patients who have the greatest likelihood of deriving the most benefit,” ...
  • 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...
  • Regulatory NewsRegulatory News

    EU Committee Urges No-deal Brexit Transition Period for Medical Devices

    The European Commission (EC) should act in the “best interest of citizens” and establish a transition period to allow manufacturers to keep placing medical devices certified by a UK Notified Body (NB) on the EU market under a no-deal Brexit, trade association COCIR urged Wednesday in an open letter. The European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry—otherwise known as COCIR—expressed its concerns around the increasingly lik...
  • Regulatory NewsRegulatory News

    MHRA Sets No-Deal Brexit Process for Pharma Submissions

    Pharmaceutical companies and clinical trial sponsors were directed to follow new guidelines for regulatory submissions that would have to be directly submitted to the UK’s Medicines and Health products Agency (MHRA) if Britain leaves the EU without reaching an agreement by the end of this month. The guidance, posted Monday, describes the steps applicants and sponsors need to follow for access to the new MHRA gateway for UK submissions from day one post-Brexit in a no-de...
  • Regulatory NewsRegulatory News

    MHRA Spells Out Post-Brexit Regulation of Medical Devices Under No-deal Scenario

    With just about a month left until Brexit, the UK regulatory authority for medical products issued updated guidance on what the medical device industry needs to know about the future device regulation under the increasingly likely scenario of Britain leaving the EU without a deal on continuing resolutions. From requiring a new role as a UK Responsible Person and additional importing and distributing obligations to a slew of new registration and classification requiremen...
  • Regulatory NewsRegulatory News

    UK Seeks to Increase Clinical Trials Transparency

    The UK government issued a policy paper to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report offered in 2018. “Research findings must be communicated in ways that are timely, meaningful and relevant to evidence users,” Parliamentary Under-Secretary of State for Health Baroness Blackwood said, welcoming the chance to address the October 2018 report . “Only with a system which values transpar...
  • Regulatory NewsRegulatory News

    MHRA Clarifies Medical Devices Policies for Users

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a new guidance document on Monday to clarify existing policies and procedures around the use of medical devices. The agency’s guidance provides information that ranges from the definition of a medical device and CE marking to information on buying devices for personal use, as well as problems associated with device use and troubleshooting. For those interested in buying a medical device for pe...