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    Chinese Heparin Contamination Questions Return With New FDA Warning Letter

    The US Food and Drug Administration (FDA) released a warning letter on Wednesday for China-based heparin contract testing lab, Shandong Analysis and Test Center, reigniting a debate over whether the questionable sources of heparin that led to almost 100 American deaths a decade ago have been rooted out. Background In 2007 and 2008, heparin sourced from Chinese manufacturers was linked to the deaths, though House Energy & Commerce committee members expressed co...
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    CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions

    To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and ...
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    Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DTAB Proposes Stipulations to Indian Plan for Permanent Licenses The Indian Drugs Technical Advisory Board (DTAB) has given its conditional support to end the need to renew licenses to make, sell and test drugs. DTAB is broadly in favor of the idea, but has suggested stipulations that are more burdensome than those proposed by the Drug Controller General of India (DCG...
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    Flying Insects and Chipping Paint: FDA Warns Chinese API Manufacturer

    Two of Xinxiang Pharmaceutical’s China-based manufacturing facilities received a US Food and Drug Administration (FDA) warning letter on 19 August after FDA inspectors found drug manufacturing equipment and facilities in such a state of disrepair as to be unsalvageable. The company, which previously received a Form 483 in 2015 and was placed on the import alert list in April, was found to be using “open equipment” for the manufacture of active pharmaceutical ingredi...
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    CFDA’s Domestic Pharma Manufacturing Site Inspections Decline Significantly

    China’s Food and Drug Administration (CFDA) in 2015 inspected less than half the number of pharmaceutical manufacturers as compared with 2014, according to a recently released annual report from the Center for Food and Drug Inspection of CFDA. The report claims that as the number of domestic inspections has decreased significantly, “the proportion of enterprises going through rectification inspection and receiving Warning Letters has significantly increased, with the rat...
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    FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers

    Three more Chinese pharmaceutical companies were added to two US Food and Drug Administration (FDA) import alert lists this week for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection. On Wednesday, FDA added Xinxiang Pharmaceutical Co. and  Xinxiang Tuoxin Biochemical Co., noting: “Only drug and drug products (i.e. adenosine, choline, uridine, uracil, cytidine, inosine, and all pharmaceutical intermediates) are sub...
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    Congressmen Slam FDA’s Handling of Investigation Into Tainted Chinese Heparin

    Several members of the House Committee on Energy & Commerce are raising new concerns over the US Food and Drug Administration’s (FDA) investigation into intentionally adulterated Chinese heparin that led to the deaths of 149 Americans in 2007 and 2008. One of the lingering concerns in the letter sent to FDA Commissioner Robert Califf on Wednesday is that a lack of communication between FDA’s Office of Criminal Investigations (OCI) and its Center for Drug Evaluation and R...
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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...