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  • Regulatory NewsRegulatory News

    Study Finds Extent of Unvalidated Surrogate Endpoint Use in Expedited Approvals ‘Concerning’

    Research published this week in PLOS Medicine raises concerns about the use of surrogate endpoints to support the marketing authorizations of products assessed via the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA) and accelerated assessment (AA) pathways. The use of the CMA and AA pathways, which is restricted to situations of “unmet medical need” and/or “in the interests of public health,” are often based on incomplete benefit-risk asses...
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    EU Regulatory Roundup: Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System   Ireland has extended the “use and learn” phase of the implementation of the Falsified Medicines Directive (FMD) for a second time. The implementation phase will now end in a staggered manner starting sometime after the end of September.   When the FMD safety feature requirements ca...
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    EU Regulatory Roundup: AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit   The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has added the active pharmaceutical ingredient (API) in AstraZeneca’s Calquence to the list of materials cleared for export to the European Union in the event of a no-deal Brexit.   If the UK leaves without a deal the E...
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    EMA Offers Q&A on Exemptions From Batch Re-Testing for Imported ATMPs

    The question and answer (Q&A) document released by the European Medicines Agency (EMA) on Wednesday describes when an exemption from EU batch re-testing can be granted for imported advanced therapy medicinal products (ATMPs). The three-page Q&A begins by noting that a Qualified Person (QP) has to ensure each batch of imported ATMP is re-tested upon importation. But the QP can certify that the imported batch relies on controls conducted in a third country if the product ...
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    EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016. In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case ...
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    FDA-EMA Workshop Discusses Quality Challenges for PRIME, Breakthrough Therapies

    Last November, officials from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) met with industry representatives in London to discuss the various quality challenges that arise when the development of investigational products is accelerated. EMA’s launch of its priority medicines (PRIME) scheme and FDA’s breakthrough therapy designation have enabled companies to speed certain treatments to market, although there have been difficulties in ...
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    Novartis’ Zolgensma Joins Growing List of Medicines to Lose Accelerated Assessment Status in EU

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently announced its decision to remove Novartis’ spinal muscular atrophy gene therapy onasemnogene abeparvovec from its accelerated assessment program. CHMP did not announce its reasoning behind the decision, which effectively means that the treatment, approved in the US as Zolgensma and launched at a price of more than $2 million, will be reviewed in the EU in 210 days rather...
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    EMA Recommends Conditional Approval for First Tissue-Agnostic Cancer Treatment

    The European Medicines Agency’s (EMA) human medicines committee (CHMP) on Friday recommended the conditional approval for the first medicine to treat tumors with a specific mutation, regardless of where in the body the tumor originated.   Bayer’s Vitrakvi (larotrectinib) is as a treatment of adult and pediatric patients with solid tumors that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, according to EMA. Treatment with Vitrakvi is recommended for ...
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    RoundupsRoundups

    EU Regulatory Roundup: MHRA Finances Hit by Brexit-Triggered Drop in Income From EMA

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Finances Hit by Brexit-Triggered Drop in Income From EMA   The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) suffered a £5.7 million ($7.1 million) drop in its income from external customers last year. MHRA attributed the 5.6% decline to the fall off in work from the European Medicines Agency (EMA) ahead of Brexit.   In the 201...
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    US and EU Fully Implement Mutual Agreement on GMP Inspections

    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities. In addition to helping reduce redundancies in manufacturing inspections, the implementation of the Mutual Recognition Agreement (MRA) means that beginning Friday, pharmaceutical companies can sto...
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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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    EMA Begins Review of Handling Errors Linked to Leuprorelin

    At the request of Germany’s BfArM, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) initiated a review of depot formulations of leuprorelin medicines because of reports of handling errors during preparation and administration that can cause some to receive insufficient amounts. EMA explains how depot formulations of leuprorelin medicines, which are better known by different brand names like Eligard, Lupron and Procren, release the...