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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...
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    FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data

    New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards. Background The draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States , is closely related to a rule proposed by FDA in February 2013. That rule, Hum...
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    Indian Pharmacist Group Calls for Stricter Regulations on Storage Temperature Instructions

    A group representing pharmacists in India is calling for regulators to amend the country's Drugs and Cosmetics Act to more strictly control how manufacturers specify temperature storage instructions for their products. Background The environment drugs and other healthcare products are stored in plays a critical role in ensuring their safety and efficacy. Manufacturers are required to control for a number of environmental factors, including temperature, humidity, ven...
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    EMA Releases Draft Guides to Reduce and Report Medication Errors

    To address the risk of medication errors, the European Medicines Agency (EMA) has released two new draft documents intended to guide regulators and industry in reporting, evaluating and preventing medication errors. Medication errors are mistakes made when prescribing, dispensing and administering medicine. The agency says these errors are the "most common preventable cause of undesired harmful effects" related to medicine in the EU. According to EMA, these errors have...
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    To Boost Transparency, Canada Launches GMP Inspection Database

    Canada's Health Minister Rona Ambrose announced the launch of a new publicly accessible database for manufacturing inspections on 13 April 2015. The new Drug and Health Product Inspection Database will allow Canadians to search for timely information on good manufacturing practice (GMP) inspections conducted by Health Canada. Background The database is part of a larger effort by Health Canada to improve transparency after being called out publicly by The Toront...
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    EU Makes Major Update to Drug Manufacturing Guidelines

    For the first time since 2001, the European Commission (EC) is updating its guidelines for pharmaceutical qualification and validation . The update to EurdraLex Volume 4, Annex 15: Qualification and Validation goes into effect on 1 October 2015. The new version accounts for significant changes in the regulatory environment and will align with guidelines from the International Conference on Harmonisation (ICH). Background Annex 15 contains the requirements for qua...
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    Health Canada to Increase GMP Inspections, Promises Greater Transparency

    Health Canada says it is boosting its efforts to inspect pharmaceutical manufacturers, and promises to be more transparent with inspection results in the future. The move comes in the wake of an ongoing investigation by The Toronto Star , which has uncovered cases of data manipulation and unreported side effects at manufacturers supplying products to Canada. The paper made these revelations after obtaining inspection reports from the US Food and Drug Administration...
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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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    With Weeks Until Drug Track and Trace System Launches, FDA Issues New Guidance

    With just weeks left until new tracking standards come into effect, the US Food and Drug Administration (FDA) is releasing new recommendations it hopes will better secure the pharmaceutical supply chain from accidents and counterfeiters alike. Background In 2013, Congress passed and President Barack Obama signed into law the  Drug Quality and Security Act  ( DQSA ). While the law is perhaps better known for its extensive pharmaceutical compounding reform provisions, it ...