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    ICH Looks to Revamp GCP Guidelines, Adds New Members

    Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week. Following discussions, ICH said it plans to conduct a broad review of its guidelines related to GCP and clinical trial design, beginning with a reflection paper expected in early 2017. "This will include updating current guidance on interventional trials and expand on...
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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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    Asia Regulatory Roundup: CFDA Proposes Sourcing Requirements for Drug, Device Companies (3 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Proposes Sourcing Requirements for Drug, Device Firms as Traceability Agenda Gathers Pace The China Food and Drug Administration (CFDA) has released another piece of its proposed strategy for implementing a traceability system across the country. In the latest text, the regulator has set out plans to make drug manufacturers assess the quality of their raw material sup...
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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...
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    EMA Takes a Firmer Stance on GCP Non-Compliance

    Drug and biotech companies cannot replace pivotal clinical trials that are non-compliant with good clinical practice (GCP) standards during the assessment of marketing authorization applications, according to a new position paper from the European Medicines Agency (EMA). Stressing the importance of GCP compliance, the EMA says it’s an “essential prerequisite” for assessing a medicinal product’s safety and efficacy. The agency also clarifies that when a study is found to...
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    US Government Agencies Crack Down on Dietary Supplement Manufacturers

    In partnership with the Department of Justice, Federal Trade Commission and others, the US Food and Drug Administration (FDA), announced that after a yearlong sweep of dietary supplement makers, the agencies have filed civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced, an 11-count indictment unsealed Tuesday against Dallas-bas...
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    HHS Inspector General to Look Into Six FDA Programs in FY2016

    Over the next year, HHS’ Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration’s (FDA) requirements for post-marketing studies for new drugs, the exchange of information between drug supply chain partners and FDA’s oversight of networked medical devices in hospitals, as well as three other programs linked to the regulation of food and tobacco. Although the majority of OIG’s work is tied to the oversight of Medicare and Medicaid fu...
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    EMA Recommends Suspending Medtronic's Inductos Over GMP Issues at CMO

    The European Medicines Agency (EMA) is calling on the European Commission to suspend the marketing authorization for Inductos, Medtronic's implant used to help new bone growth in patients with spinal disc problems and leg fractures. The recommendation comes after a follow up inspection of a US manufacturing site was found to be "non-compliant with manufacturing requirements [and] did not have adequate measures in place to prevent particle contamination." While EMA notes...
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    Updated: MHRA Suspends UK Company's MS License

    Late last month, the UK's Medicines & Healthcare products Regulatory Agency (MHRA) suspended the manufacture specials (MS) license of a UK company that recently made a push into the US. The MHRA did not reveal what caused it to suspend Bionical Limited's license , but according to MHRA's most recently updated list of suspensions, the license is suspended until 18 February 2016. Jonathan Hughes, business development director of Bionical, told RAPS that the suspension c...
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    EMA to Review InductOs After US Manufacturer Cited for Contamination Issues

    The European Medicines Agency (EMA) has announced it is conducting a review of Medtronic's implantable bone-development product, InductOs, after Spanish and Dutch inspectors discovered contamination issues at a US manufacturing site which makes one of its components. Background InductOs was authorized via the centralized procedure in 2002 and is marketed by Medtronic BioPharma B.V., headquartered in the Netherlands. InductOs is used to promote bone development in pati...