• Regulatory NewsRegulatory News

    Four Pharma Companies Lead in Regulatory, Legal Compliance

    Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index. Background Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies again...
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    European Regulatory Roundup: When is an App a Medical Device? MHRA Explains (25 August 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Updates Guidance on Determining Whether an app is a Medical Device The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance on determining whether an app is classified as a medical device. The new guidance features revised flowcharts to help software developers understand whether an app needs a CE mark. MHRA released ...
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    EMA Releases List of Medical Events for Pharmacovigilance Monitoring

    The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events. EMA says the list will assist it and other regulators to prioritize the review of suspected adverse events that "deserve special attention, irrespective of statistical criteria used to prioritize safety reviews," and contribute to the agency's day-to-day pharmacovigil...
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    EMA Adopts New Biologic, Biosimilar Pharmacovigilance Guidance

    The European Medicines Agency (EMA) on Monday announced new recommendations for monitoring the safety of biologics and biosimilars. The guidance will take effect on 16 August 2016. The new recommendations are part of a new chapter of EU good pharmacovigilance practice (GVP) guidelines, titled Product- or population specific considerations II: Biological medicinal products . Background Pharmacovigilance is the process of monitoring the use of drugs after they have ente...
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    EU Regulators Tout Progress on Pharmacovigilance Since New Legislation Enacted

    The European Commission (EC) and European Medicines Agency (EMA) say their combined efforts have resulted in improved drug safety monitoring since new legislative requirements went into effect in 2012, according to a report released by the EC on Monday. "The analysis shows that the new system has been successful at detecting safety issues more quickly, thus enabling regulators to take rapid action when needed and provide advice and warnings to users of medicines," EMA wr...
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    EMA Recommends Suspending Alkem Drug Over Flawed Studies

    The European Medicines Agency (EMA) on Friday recommended suspending the marketing authorization of a drug made by Indian generic manufacturer Alkem Laboratories over data integrity issues at the company's bioequivalence facility in Taloja, India. In light of the issues, EMA says that studies conducted by Alkem at the facility between March 2013 and March 2015 cannot be relied on to support marketing authorizations. The recommendations stem from a review EMA launched i...
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    Croatian Regulator Cites Indian Manufacturer for QA, GMP Violations

    The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) on Monday issued a statement of non-compliance to Indian active pharmaceutical ingredient (API) manufacturer Dhanuka Laboratories Ltd. The notice was issued following an inspection of Dhanuka's Gurgaon, India facility conducted on 19 February 2016, during which inspectors discovered 32 good manufacturing practice (GMP) violations, including one critical violation involving Dhanuka's "weak" quality ...
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    Off-Label Drug Use and Pharmacovigilance: EMA Outlines What MAHs Need to Collect and Report

    Pharmaceutical companies operating in the EU will need to collect and report information on the off-label use of their medicines under new obligations making their way from draft to final form at the European Medicines Agency (EMA) this summer. In late April, EMA offered a reflection paper , open for comment through 29 July, which offers the agency’s proposal for the collection and reporting of information on off-label use for marketing authorization holders (MAHs), in ...
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    European Regulatory Roundup: EMA Sets Up Antimicrobial Monitoring Program (14 April 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Sets out 5-Year Strategy for Antimicrobial Monitoring Program The European Medicines Agency (EMA) has published a draft strategy for the next five years of its program to monitor the use of antimicrobials. Over the period covered by the document, EMA plans to continue expanding the number of countries from which it gathers data with a view to ultimately covering ev...
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    EMA Begins Pharmacovigilance Training Courses

    The European Medicines Agency (EMA) this week began running a series of pharmacovigilance training sessions to help companies and regulators meet their obligations when using EudraVigilance, a centralized European database of suspected adverse reactions to medicines in the European Economic Area (EEA). At least one user from each national competent authority, marketing-authorization holder or sponsor of clinical trials in the EEA should complete the training to ensure th...
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    European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Proposes Major Changes to Pharmacovigilance Risk Management System Guidelines The European Medicines Agency (EMA) has proposed major changes to its good pharmacovigilance practices (GVP) module on risk management systems. EMA wants to implement the modifications to bring the guidelines in line with its current thinking, which has evolved over the past three years as it ...
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    Device Industry Calls for Clarifications to Draft Animal Studies Guidance

    The Advanced Medical Technology Association (AdvaMed) is calling on the US Food and Drug Administration (FDA) to clarify aspects of a recent draft guidance intended to set expectations for animal studies for medical devices. Draft Guidance FDA released the draft guidance, General Considerations for Animal Studies , for public comment in October 2015. The guidance is intended to assist industry in designing, conducting and reporting data from animal studies used to de...