• Regulatory NewsRegulatory News

    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Technology Association (AdvaMed) is calling on the US Food and Drug Administration (FDA) to clarify aspects of a recent draft guidance intended to set expectations for animal studies for medical devices. Draft Guidance FDA released the draft guidance, General Considerations for Animal Studies , for public comment in October 2015.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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    Three Asian Companies Banned From Sending Imports to the US by FDA

    China-based Jinan Jinda Pharmaceutical Chemistry Co., Zhejiang Qianfei Enterprise Co. and Hong Kong-based Chan Yat Hing Medicine Factory were added to the US Food and Drug Administration’s (FDA) import alert list over the last two weeks, effectively banning the companies from shipping products to the US. FDA has now added 21 new companies to its import alert list in 2015, with companies listed from Canada (1), China (4), Czech Republic (1), Denmark (1), Hong Kong (1), In...
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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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    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...
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    EMA Launches Parallel Distribution Database

    To boost transparency for re-exported drugs, the European Medicines Agency (EMA) has created a new publicly available online register for parallel distribution notices. Background Parallel distribution, often referred to as re-exportation, allows companies in the EU to distribute centrally authorized medicines between member states, independent of their marketing authorization holder. This practice makes it possible for cheap drugs in one Member State to be distributed ...
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    Indian API Manufacturer Faces Canadian Quarantine Over Data Integrity Issues

    After Slovenian inspectors uncovered serious issues at Indian active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories, Health Canada has issued a voluntary quarantine for all products containing APIs sourced from the company. Background On 18 March 2015, inspectors from Slovenia's drug regulator JAZMP uncovered evidence of serious good manufacturing practice (GMP) deficiencies at Polydrug's facility in Maharashtra, India. In their report, filed to the...
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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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    AmpliPhi Biosciences Gets First cGMP Certification for Bacteriophage Facility

    AmpliPhi Biosciences announced Wednesday it has received the first ever good manufacturing practices certification for its bacteriophage facility in Slovenia. Background Bacteriophages are naturally occurring viruses that are capable of fighting bacteria. Phage therapy has been around for nearly a century, following the co-discovery of bacteriophages by Frederick Twort and Felix d'Hérelle in 1915 and 1917, respectively. Shortly thereafter, scientists began developing...