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  • Regulatory NewsRegulatory News

    EMA explains GMP and GDP flexibilities amid COVID-19

    The European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP).   (RELATED: EMA Q&A explains regulatory expectations for drugs during the...
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    Health Canada releases guidance to streamline COVID-19 clinical trials

    Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19.   The guidance documents support an interim order (IO) that reduces the administrative burden of clinical trials and promotes efficient investigation of drugs and medical devices to treat, prevent, mitigate or diagnose COVID-19.   The IO has dropped administrative requirements for non-significant changes during a...
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    FDA approves IV artesunate for severe malaria

    The US Food and Drug Administration (FDA) on Tuesday approved what is now the only treatment for severe malaria in the US following the marketing discontinuation of Eli Lilly’s quinidine in 2019.   The approval was granted to Amivas, LLC for its intravenous (IV) artesunate product, which was co-developed with the US Army under a cooperative research and development agreement (CRADA) that began in 2017 and led to the Army granting Amivas an exclusive license to a p...
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    FDA labeling study helps clear path for OTC naloxone

    Consumers reading a model drug facts label for naloxone could understand labeling sufficiently to use the opioid antagonist safely and effectively without the support of a healthcare provider, according to a label-comprehension study conducted by the US Food and Drug Administration (FDA).   The unusual move by the FDA could help clear a hurdle to approval of over-the-counter injectable and intranasal naloxone; many public health experts concerned about the impact of th...
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    FDA explains impact of COVID-19 on applications, formal meetings

    The US Food and Drug Administration (FDA) on Tuesday issued immediately effective guidance explaining how the coronavirus disease (COVID-19) public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications.   The guidance features 11 questions and answers on how the agency intends to handle disruptions affecting meetings and goals under its user fee programs established by the Prescription Drug User Fee Act (P...
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    New approvals and indication from FDA: Alunbrig, VESIcare LC, Kynmobi and more

    This is the first in a series of weekly roundups of new drug approvals and indications from the US Food and Drug Administration (FDA).   Alunbrig gets new indication as first-line therapy for ALK-positive metastatic NSCLC On 22 May, FDA approved a new indication for Takeda’s Alunbrig (brigatinib) as a first-line treatment for adults with anaplastic lymphoma kinase‒positive metastatic non‒small cell lung cancer (NSCLC). The agency also approved a companion diagnost...
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    FDA warns South Korean firm for inadequate training, insufficient personnel monitoring

    A South Korean drug manufacturing firm was cited by the US Food and Drug Administration for having insufficiently trained personnel and for insufficient monitoring of aseptic processing areas.   The deficiencies were detected in an October 2019 FDA inspection of Samchundang Pharm’s Hwaseong facility. The agency found that Samchundang failed to establish the suitability of the sterility test method it used for final release of its drug products and also didn’t determi...
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    New York ophthalmic drugmaker cited for environmental and data integrity issues

    The US Food and Drug Administration (FDA) has warned a New York based pharmaceutical company for data falsification and failing to establish adequate monitoring in aseptic processing areas.   The firm, Altaire Pharmaceuticals, manufactures sterile ophthalmic drug products, as well as over the counter ophthalmic and homoeopathic products.   In its warning letter dated 12 March 2020, the FDA detailed findings from a 2019 inspection, where inspectors found that the ...
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    FDA consults on ICH residual solvents update

    The US Food and Drug Administration (FDA) on Tuesday launched a two-month public consultation on an International Council for Harmonisation (ICH) guideline establishing new permitted daily exposures (PDEs) for three residual solvents.   Specifically, the ICH Q3C(R8) guideline is a product of the maintenance procedure for updating ICH’s guideline for residual solvents as new toxicological data for become available. The eighth revision to the guideline adds PDEs for thre...
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    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,” ...
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    EMA strengthens ENCePP mandate to address COVID-19 pandemic

    The European Medicines Agency (EMA) has strengthened the mandate for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), creating a COVID-19 Response Group working within ENCePP to aid in pharmacovigilance and pharmacoepidemiology work amid the pandemic. EMA said the new mandate is necessary to address “unprecedented challenges for the epidemiological and regulatory communities” in addressing COVID-19. “This role would give ENCePP ...
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    FDA updates COVID-19 compounding guidance with reporting clarification

    Two guidance documents related to compounding drugs during the coronavirus pandemic were updated by the US Food and Drug Administration (FDA) on Thursday. Among other updates, a requirement for weekly reporting will allow hospitals to identify which compounders are making what quantities of drugs currently in shortage during the public health emergency of the COVID-19 pandemic.   The FDA updated two separate guidance documents regarding compounding of fifteen drugs tha...