• Regulatory NewsRegulatory News

    Euro Roundup: Onslaught of Brexit guidances from MHRA; Swissmedic's adverse event reporting challenges

    MHRA publishes 48 guidance documents on new regulatory regime   The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published 48 guidance documents on the processes that will apply now that the Brexit transition period has ended. Throughout 2020, MHRA published guidance on how drugs and medical devices would be regulated in the UK after Brexit. In the days before and after the transition period ended on 31 December, the agency released a flurry o...
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    What’s in the Brexit trade deal for the pharmaceutical and medical device industries?

    After years of painstaking negotiations, the UK parted ways with the EU on 1 January after an 11-month transition period with a 1,200-plus page trade deal in hand, narrowly avoiding a no-deal scenario.   The trade deal, which was reached on 24 December, avoids tariffs and quotas on goods traded between the EU and UK and sets forth some provisions for cooperation and alignment on a range of issues from transportation to environmental protection but avoids major topics...
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    MHRA authorizes Pfizer-BioNTech COVID vaccine as FDA, EMA set more conservative timeline

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted temporary authorization on 2 December to Pfizer and BioNTech’s mRNA-based BNT162b2 COVID-19 vaccine, vaulting ahead of regulators in the US and EU.   The temporary authorization is “batch-specific” and applies only to a single batch of the vaccine. Subsequent batches must be approved by MHRA and must meet the same authorization conditions as the initial batch. MHRA said the decision was mad...
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    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 , ...
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    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...
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    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 ...
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    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 ...
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    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...
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    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...
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    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.   ...
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    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...
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    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...