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    FDA and EMA mostly align on GCP inspection deficiencies, study finds

    A study conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) found that the agencies are identifying the same types of deficiencies in joint good clinical practice (GCP) inspections with respect to protocol compliance, documentation deviations, and human subject protections.   The paper follows a mutual transatlantic cooperation on GCPs between the regulators that went into effect on 1 September 2009. Under the program, regulators ...
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    ICH announces sign-off on good clinical practices guideline

    The International Council for Harmonization (ICH) recently announced that the E8(R1) guideline on general considerations for clinical studies had reached Step 4 and is awaiting sign-off by regulators. The widely anticipated guideline modernizes the design, conduct and reporting of clinical trials by adopting quality by design principles. The guideline incorporates “current concepts achieving fit-for-purpose data quality.”   ICH announced that “the modernisation of IC...
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    European Commission Adopts Two Acts on GMPs for Medicines

    Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use. One of the acts is an  implementing directive  that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorization ( see Article 40 of the Community code Directive (2001/83/EC) ). The ...
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    Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration

    With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion. The new toolkit, born out of a five-year collaborative project that actually took four years to complete, brings expertise from the US Pharmacopeial Convention (USP), US Food and Drug Admin...
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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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    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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    What Life Sciences Companies Need to Know About the Foreign Corrupt Practices Act

    In 2014, enforcement actions related to the Foreign Corrupt Practices Act (FCPA ) generated fines totaling more than $1.5 billion with the average corporate penalty exceeding $156 million. Also in 2014, the US Department of Justice (DOJ) announced it would hire an additional 300 agents to focus solely on FCPA investigations and enforcement. On 3 March 2015, the director of the Division of Enforcement of the Securities and Exchange Commission (SEC) stated, “…in 2015, th...
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    FDA Bans Drugs Made by Indian Manufacturer Over GMP Problems

    US medicines regulators have quietly banned drugs manufactured at a facility owned by Ipca Laboratories, an Indian pharmaceutical manufacturer, from entering into the US after finding that its products were not manufactured to federal standards. On Thursday, 22 January 2015 the US Food and Drug Administration (FDA) issued an update to its Import Alert 66-40, which is used to warn US customs officials that a company's products have not met good manufacturing practices (GM...
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    China Adopts Milestone Device Good Supply Practices

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices. The GSP regulatio...
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    What’s In a Name? The Value of Pharmaceutical & Biologic Branding

    September 2014 marks 30 years since the Hatch-Waxman Amendments (Hatch-Waxman) to the Food, Drug, and Cosmetic Act (FD&C Act) introduced generics as we know them. Hatch-Waxman strove to offer consumers the benefits of “rapid availability of lower-priced generic versions of innovator drugs” 1 while preserving a meaningful period of market exclusivity for innovators to recoup their costs. In the process, however, Hatch-Waxman established conditions that fundamental...
  • EMA Tries to Clamp Down on Revolving Door of Regulators

    EU regulators have released a new "best practices" guide intended to steer the European Medicines Agency (EMA) clear of the types of perceived conflicts of interest that plagued the agency's former leader. Background In 2012, EMA was publicly chided by the European Court of Auditors (ECA), which said it had inadequately managed situations involving conflict of interest (COI). While those COIs spanned a wide number of areas, among the most critical identified was the ...
  • Revised EU Distribution Rules Target Falsified Medicines

    The European Commission issued final revised Good Distribution Practices (GDP) guidelines  on 8 March 2013 that are designed to incorporate the requirements of a 2011 Directive that targets so-called "falsified medicines" from entering the legal supply chain of the EU.  A draft version of the revised GDPs was issued for public comment (consultation) in July 2011 by the Commission, which noted at the time that the 1994 version of the GDPs was "no longer adequa...