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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Novartis Faces MHRA Criticism on Trial Data Access (21 July 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Novartis Faces MHRA Criticism Over Access to Trial Data Novartis has revealed the Medicines and Healthcare Products Regulatory (MHRA) has criticized its UK operation following an inspection. The criticisms center on the systems Novartis’ UK unit uses to provide health authorities with access to trial data. Specifically, Novartis said MHRA inspectors were critical of t...
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    EC Report Analyzes Regulatory Frameworks for Advanced Therapies in US, Canada, Japan and Korea

    The European Commission report released Wednesday dissects the similarities in how gene-, cell- and tissue-based advanced therapies are regulated across the four different geographic regions, though ongoing research projects in such therapies are heavily concentrated in the US and Japan. The 327-page report highlights the “high degree of convergence” in the regulation of advanced therapies across the US, Canada, South Korea and Japan, noting that only Japan has enacted (...
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    Swissmedic Sees Spike in Adverse Event Reports for Third Straight Year

    In a new report on its work in 2015, Switzerland’s drug and medical device regulator Swissmedic has seen a sharp rise in the number of suspected adverse drug reaction (ADR) reports received (7.1% increase from 2014 and a more than 30% increase from 2013), due mainly to an increased volume of reports from industry. “The number of follow-ups to ADR reports is now also being recorded as a big increase in the number of reports was observed during the year and they are labour...
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    FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

    The US Food and Drug Administration (FDA) again pushed back (from later this summer until April 2017) its finalization of a contentious rule that would allow generic drug companies to update labels like their brand name counterparts. An FDA spokeswoman told Focus that the new date for the finalized rule is a “projected” date “that may be adjusted to reflect ongoing work,” though she could not offer any specifics on why this date was pushed back for this rule. The pro...
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    Drug Safety Reports Still Uninformative, FDA Officials Say

    Most expedited safety reports for investigational new drugs (INDs) are uninformative, despite recent efforts to improve the quality of such reports, FDA officials wrote in a recent research article. Sponsors are required to compile all adverse events for drugs they are studying in annual safety reports. If an adverse event is serious, unexpected or suspected to be caused by the drug being studied, sponsors are required to submit an expedited report to FDA within 15 days ...
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    CBER Unveils New Electronic Reporting System for Vaccine Adverse Events

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday announced the availability of an electronic submission system for companies to submit adverse events linked to vaccines. The launch of the system, which is part of the Vaccine Adverse Event Reporting System (VAERS) run jointly by FDA and the Centers for Disease Control and Prevention, follows guidance released in August 2015 that offers recommendations on the ele...
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    CBER Calls on HCT&#47P Manufacturers to Report Adverse Events Within 15 Days

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Tuesday issued new guidance to provide establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable diseases. CBER notes that examples of HCT/Ps that are subject to adverse reaction reporting and fall with...
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    New Guidance Spells Out How to Comply With EMA’s Clinical Data Publication Policy

    The European Medicines Agency (EMA) has published new guidance for pharmaceutical companies on how to comply with its new policy on the publication of clinical data. The policy, which entered into force on 1 January 2015, applies to clinical reports contained in all marketing authorization applications (MAAs) submitted on or after this date and the reports will be made publicly available in September 2016 . The 91-page guidance document features four chapters, in...
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    FDA Urges Caution With Neurosurgical Head Holders Due to Slippage

    The US Food and Drug Administration (FDA) issued a safety notice Thursday on the use of neurosurgical head holder (skull clamp) systems, which secure the patient’s head during surgical procedures. From January 2009 to January 2016, the agency said it received more than 1,000 medical device reports (MDRs) associated with the slippage or movement of a skull clamp before and/or during surgical procedures, resulting in more than 700 injuries, though the review did not find ...
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    MHRA: Safety Updates Will No Longer be Submitted to National EU Regulators Beginning in June

    From 13 June 2016 onward, companies across Europe will no longer submit periodic safety update reports (PSUR) to national regulators but instead to a central repository at the European Medicines Agency (EMA). The repository was created under legislation introduced in July 2012 and also provides for the storage of associated assessment reports, additional data and comments. “This will apply for all products including those only approved in the UK. From 13 June 2016 the...
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    CBER: Most Frequently Reported HCT/P Deviations

    For manufacturers of non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), FDA released draft guidance on Wednesday outlining the most frequently reported HCT/P deviations reported to the Center for Biologics Evaluation and Research (CBER). Under FDA’s authority, a manufacturer of non-reproductive HCT/Ps must investigate and report to the agency all HCT/P deviations related to a distributed product for which the establishment performed a...
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    FDA Offers Draft Guidance on IND Safety Reporting

    For investigational new drug application (IND) sponsors running clinical trials and debating when a serious adverse event can be linked to an investigational drug and is serious enough to unblind data, FDA offered new draft recommendations on Wednesday. The new guidance on IND safety reporting follows previous guidance on Safety Reporting Requirements for INDs and BA/BE Studies from 2012 and contains specific details on: The composition and role of a safety assessment ...