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    Asia Regulatory Roundup: CFDA Revises Guidance on Device Trials (29 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Introduces Revised Guidance on Clinical Trials of Medical Devices China Food and Drug Administration (CFDA) has introduced a good clinical practice (GCP) document covering medical devices. The text describes how CFDA expects sponsors and other organizations to handle aspects of medical device trials, from the initial preparations through to the maintenance of da...
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    Asia Regulatory Roundup: CFDA Investigates $88M in Improperly Refrigerated Vaccines (22 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Calls for Investigation Into Sellers of $88M Worth of Improperly Refrigerated Vaccines The China Food and Drug Administration (CFDA) is pressuring local government officials to probe the sale of RMB 570 million ($88 million) worth of improperly refrigerated vaccines. Police officials think the substandard vaccine ring, which was allegedly run by a mother and daughter t...
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    Chinese Heparin Sourcing Questions Resurface After ANSM Inspection

    France's National Agency for Medicines and Health Products Safety (ANSM) raised two critical deficiencies over a Chinese pharmaceutical company’s manufacture of heparin, which harkens back to the scandal from 2007 and 2008 when heparin sourced from Chinese manufacturers killed 149 Americans. Following the December inspection of Dongying Tiandong Pharmaceutical Co.’s Dongying City-based manufacturing site, the site has been issued a statement of non-compliance and cannot ...
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    Registration Procedures for Medicinal Products in China

    This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs. An increasing number of pharmaceutical companies based outside China are interested in marketing their products in China as evidenced by the increasing number of clinical trial and marketing applications submitted by foreign companies. Obtaining marketing authorization approval equal to an Import Drug License (IDL) approv...
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    DSHEA: Preserving Legal Access to Chinese Herbal Medicine or Researching new Remedies for Malaria and Other Tropical Diseases

    This article explores the importance of continued access by researchers to Chinese medicinal herbs via DSHEA, in light of a potential increase in tropical diseases in historically non-tropical regions. Preserving access to traditional Chinese medicine will become important as tropical diseases gradually become endemic to the United States. As the climate warms 1 and mosquitos proliferate, 2 diseases formerly confined to the tropics are moving north. 3 Si...
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    China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval

    Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...
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    Chinese Company Used Suppliers Linked to Contaminated Heparin Scandal, FDA Claims

    A Chinese-based manufacturer of heparin products has been sent a Warning Letter by the US Food and Drug Administration (FDA) after regulators accused the company of preventing FDA inspectors from accessing the facility earlier this year, and possibly manufacturing contaminated products. Background In its 29 September 2014 Warning Letter to Beijing Shunxin Meihua Bio-technical Co., Ltd, FDA said its inspectors were unable to access the majority of the company's Beijing...
  • New FDA Guidance Aims to Better Assess Side Effects of Low Molecular Weight Heparins

    Patients being treated with low-molecular weight heparins-anticoagulants used to prevent and treat blood clots-are susceptible to potentially fatal adverse events known as heparin-induced thrombocytopenia ( HIT ). A new guidance document published by the US Food and Drug Administration (FDA) hopes to better warn patients of those risks through strengthened testing requirements. Background As FDA explains in its new guidance document, Immunogenicity-Related Consideratio...
  • Legislators Say Acquisition of US Pork Supplier Would Imperil Safety, Availability of Heparin

    House legislators are bringing new and critical attention to a proposed purchase of Virginia-based Smithfield foods, the world's largest pork processor, by Chinese company Shuanghui International, citing a past healthcare product regulation scandal that left dozens dead and few questions answered. Background In 2007 and 2008, regulators were left scrambling as dozens US citizens died after consuming products contaminated with adulterated heparin, a substance derived fro...
  • With Eye on Tainted Chinese Heparin Scandal, FDA Finalizes Quality Monitoring Guidance

    The US Food and Drug Administration (FDA) has released a finalized guidance document recommending certain practices for monitoring the quality of crude heparin, a response to systemic failures in quality monitoring in 2007 and 2008 that resulted in the deaths of nearly 150 Americans. Background: Scandal and Death The final guidance is similar to one released in February 2013 and aims to "help active pharmaceutical ingredient (API) manufacturers, pharmaceutical and medic...
  • FDA Plans Multi-Year Investigation Into Rare Side-Effect of Heparin

    The US Food and Drug Administration (FDA) has announced that it will give researchers a quarter of a million dollars to help identify the source of a major safety risk now affecting heparin products. Heparin, a mixture of non-standard-length polysaccharides, acts as an anticoagulant under normal circumstances. However, a notable side effect known as heparin-induced thrombocytopenia (HIT) results in a decrease of platelets in the blood resulting in the release of abnormal...
  • EMA Releases Draft Guideline on Biosimilar Heparin Products

    The European Medicines Agency (EMA) has released a draft scientific guideline on the development of biosimilar low-molecular-weight heparins, a type of medical product often used in surgical settings as an anticoagulant and incorporated into a wide range of products. The guideline specifically pertains to two types of heparin: low molecular mass heparins (LMMH) and low molecular weight heparins (LMWH), both typically sourced from the intestinal mucosa of pigs. Non-Cli...