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  • Regulatory NewsRegulatory News

    EMA kicks off rolling review of Gilead’s remdesivir

    The European Medicines Agency (EMA) on Thursday said it has started a “rolling review” of Gilead’s investigational coronavirus disease (COVID-19) drug remdesivir after preliminary results from a US study found patients taking the drug recovered 31% faster than patients taking a placebo.   Preliminary results from the study, run by the National Institutes of Health (NIH), were announced Wednesday, the same day that less promising results from a Chinese study of the dr...
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    FDA creates umbrella emergency pathway for COVID-19 serology tests

    The US Food and Drug Administration (FDA) has created a new pathway to support the emergency authorization of tests for antibodies of the virus that causes COVID-19.   Serology tests could play an important role in the safe lifting of lockdowns by enabling authorities to identify individuals with antibodies of the SARS-CoV-2 virus and calculate what proportion of a population has already been infected. The pathway unveiled by FDA on Wednesday gives test developers a ne...
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    FDA lifts drug supply chain security requirements for COVID-19 products

    The US Food and Drug Administration (FDA) on Thursday issued guidance detailing exclusions and exemptions to certain requirements under the Drug Supply Chain Security Act triggered by the coronavirus disease (COVID-19) public health emergency.   FDA says the guidance is meant “to help ensure adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19.”   Background   The DSCSA was signed into law in 2013 and est...
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    EMA explains new pharmacovigilance inspection follow-up procedures

    In a newly posted guideline that takes effect Friday, the European Medicines Agency (EMA) explains EU-wide follow-up procedures for pharmacovigilance inspections.   The 15-page document supersedes an earlier version for 2014 and includes new sections and a more detailed timeframe for post-inspection actions.   Following inspections, EMA says that lead inspectors should propose deadlines for responses to inspection findings, which should routinely be set at 30 worki...
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    CMDh explains impact of COVID-19 on mutual recognition, decentralised procedures

    The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) last week explained how regulatory flexibilities for medicines amid the coronavirus disease (COVID-19) pandemic apply to products reviewed or authorized under mutual recognition and decentralised procedures.   The guidance comes after the European Commission, European Medicines Agency (EMA) and Heads of Medicines Agencies explained their regulatory expectations for medicinal prod...
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    FDA guides generic drugmakers on bioequivalence study disruptions amid COVID-19

    The US Food and Drug Administration (FDA) on Tuesday gave advice to generic drugmakers on handling disruptions to bioequivalence studies needed to support abbreviated new drug application (ANDA) approval as a result of the coronavirus disease (COVID-19) pandemic.   On top of the massive health and economic toll caused by the outbreak, clinical trials have been particularly hard hit as dozens of drugmakers have halted or delayed studies and as they grapple with the im...
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    FDA, EU authorities update guidance on clinical trials during COVID-19

    The European Commission and European Medicines Agency (EMA) on Tuesday updated their guidance on managing clinical trials during the coronavirus disease (COVID-19) pandemic, adding advice on distribution, data verification and communicating with authorities.   The updated guidance follows a recent similar update from the US Food and Drug Administration (FDA), which added seven new questions and answers to its document.   European Commission guidance   The updat...
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    EMA warns against unapproved cell therapies

    Following the recommendation of its Committee for Advanced Therapies (CAT), the European Medicines Agency (EMA) on Tuesday warned patients against using unapproved and unregulated cell therapies, citing serious and potentially fatal side effects.   Across the Atlantic, the US Food and Drug Administration (FDA) has repeated similar warnings for years and has sent numerous warning and untitled letters to manufacturers, distributors and clinics for marketing unapproved st...
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    ICMRA members pledge clinical, regulatory support for COVID-19 products

    Members of the International Coalition of Medicines Regulatory Authorities (ICMRA) on Tuesday pledged to work together to speed the development and approval of medical products used in the fight against coronavirus disease (COVID-19).   The statement follows several meetings organized by ICMRA aimed at developing a consensus among its members on data requirements for Phase 1 clinical trials for COVID-19 vaccines , developing therapeutics for the disease and using r...
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    MDCG posts five new guidances

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for postmarket clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators.   Equivalence   Under the EU Medical Devices Regulation (MDR), it is possible to use clinical data related to an “equivalent device” in the clinical evaluation...
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    German notified body is 13th designated under MDR as MHRA plots delay guidance

    Germany’s mdc medical device certification GmbH was designated as the 13 th notified body under the EU Medical Devices Regulation (MDR) on Saturday, just one day after the one-year delay to MDR became official.   “After a three-year preparation, assessment and approval period, we are proud to have achieved this important goal,” mdc said in a statement. The notified body is also designated under both the EU medical device and in vitro diagnostic directives.   The...
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    FDA drafts guidance on emergency-use injector reliability

    The US Food and Drug Administration (FDA) this week issued draft guidance explaining how combination product developers can demonstrate that their emergency-use injectors will reliably deliver drugs as intended in a life-threatening emergency.   The guidance specifically applies to emergency-use injectors that are prefilled or co-packaged with emergency drugs or biologics, such as those to treat anaphylaxis, and is intended to expand on FDA’s 2013 guidance Technical ...