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  • Feature ArticlesFeature Articles

    Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy

    This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to development of strategies for nutrition and clinical...
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    EMA nominates executive director to replace Rasi

    The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director.   Rasi, whose second term as EMA executive director ends on 15 November, served as Executive Director from 2011-2014 before being forced to step down after the European Union Civil Service Tribunal annulled his appointment. (RELATED: Rasi returns to head EMA for five-year term , Regula...
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    Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers

    This article summarizes FDA enforcement policy during the early months of the COVID-19 public health emergency and outlines the regulatory considerations for temporary enforcement discretions. The authors emphasize the importance of routine and scientific communication between the FDA, industry, and providers to facilitate the long-term directions of these technologies.   Introduction Historically, the US Food and Drug Administration (FDA) has played an important rol...
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    Update on trade issues affecting the dietary supplement industry

    This article discusses recent updates on US trade policy issues in the dietary supplement industry. It focuses on the trading relationship between the US and its largest trading partners, including China, and analyzes the ongoing effects of current trade policies on companies that produce, buy, and sell dietary supplements. The authors discuss tools available to US companies to reduce financial liability when trade policies are evolving at a rapid pace.   Introduction ...
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    Danish Medicines Agency Ramps Up Capacity in Medical Devices

    The Danish Medicines Agency's Medical Devices Unit is “massively building up capacity” in the area of medical devices, the agency said Tuesday, to better deal with the incoming EU device legislation and to address rapid changes in technological development. A new fee structure will allow the devices unit to increase its staff capacity from about 14 employees to about 40 employees once all new employees have been recruited next spring. The unit will also work more closel...
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    EMA Tells Pharma Companies to Continue to Prep for UK’s Withdrawal

    With an extension in place that will push the UK's withdrawal from the EU back to either April or May, the European Medicines Agency (EMA) told pharmaceutical companies on Monday to continue their preparations for Brexit. Under the European Council decision from last Friday, if the withdrawal agreement between the UK and the EU is approved by the UK House of Commons by 29 March 2019, the extension will be until 22 May 2019. But if the withdrawal agreement is not approve...
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    EMA Launches Operations in Amsterdam

    The European Medicines Agency (EMA) on Monday kicked off operations at its temporary premises at the Spark building in Amsterdam Sloterdijk after moving out of its Canary Wharf office in London on 1 March.   EMA says it is also working with Dutch authorities to finish readying its temporary premises ahead of 30 March, when the agency’s seat officially switches from London to Amsterdam.   “By Monday 18 March, when EMA will be settled in the Spark building, close to ...
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    FDA Reverses Course, Decides Not to Add Suffixes to Older Biologics’ Nonproprietary Names

    The US Food and Drug Administration (FDA) has decided not to go back and rename biologics’ nonproprietary names with nonsense suffixes, as it once said it would, raising questions about the confusion that will likely come from a subset of biologics’ and biosimilars’ names containing suffixes while another subset of biologics’ names will not contain suffixes. Since 2015, FDA has been adding the meaningless suffixes to biosimilars' nonproprietary names as part of an effor...
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    EMA Expands Online Portal for Parallel Distribution Submissions

    The European Medicines Agency (EMA) on Monday announced that going forward, parallel distributors will be required to use its recently launched secure online portal, known as Iris, to manage and submit parallel distribution notifications.   Background   Parallel distribution, also known as re-exportation, is a process by which companies in the EU distribute centrally authorized medicines between member states, independent of their marketing authorization holder (...
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    European Commission Consults on Orphan Drug Applications

    The European Commission on Tuesday launched a targeted consultation to provide input on a revision of its guideline on the content and format of applications for orphan drug designation, as well as the transfer of designations between sponsors.   "The comments received will be taken into account by the European Commission in the finalization of the guideline on the format and content of application for designation as orphan medicinal products and on the transfer of des...
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    European Commission Updates Q&A on Safety Features for Medicinal Products

    The European Commission recently released an updated document setting out nine new and one revised frequently asked questions and answers on the implementation of the rules on the safety features for medicinal products for human use. Building off a previous update in November , five of the new questions deal with general issues, like whether medicinal products can carry more than one batch number, or whether during the transitional period manufacturers located in the E...
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    UK Looks to Ensure Pharma Submissions Can Continue Under No Deal Brexit

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to ensure that if the UK leaves the EU without a deal, pharmaceutical companies can continue to submit regulatory and notification information to the UK. “If the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Submissions related to human medicines would need to be submitted directly to the MHRA,” the agency said. ...