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    CDRH and CDER Send Warning Letters to Six Asian Companies

    The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan. The most recent letter, sent from FDA’s Center for Drug Evaluation and Research (CDER) to Bangalore, India-based active pharmaceutical ingredient (API) manufacturer Resonance Laboratories on 3 February, following a four-day inspection last May, says in...
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    Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown

    A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety. Back in 2008, FDA opened its first foreign offices as part of its res...
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    FDA Warns Chinese Drugmaker for Refusing Inspection, Unsanitary Conditions

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 8 December to China-based Baoying County Fukang Medical Appliance with six violations. During the June inspection, FDA says its inspector asked a company representative to “explain the microbiological testing processes” for products manufactured and distributed in the US from the plant, but the representative said that information is protected as a trade secret. “Our investigator expla...
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    FDA Warns Chinese Heparin Manufacturer, Reigniting Questions of Contamination

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to a China-based manufacturer of heparin—the same manufacturer warned by French regulators last March. The letter says the company used crude heparin batches that potentially were out of specification (OOS) to manufacture heparin sodium for the US market and shows that previous issues related to heparin sourced from Chinese active pharmaceutical ingredient (API) manufac...
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    FDA Warns Chinese Drug Manufacturer for Limiting Inspection, Systemic Data Manipulation

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Beijing Taiyang Pharmaceutical Industry Co. on 19 October after the company limited FDA’s ability to conduct an inspection and manipulated manufacturing data. The warning letter follows FDA adding the company to two import alert lists in April, effectively halting its ability to ship products to the US. Barred Entry to Warehouse On 16 November 2015, FDA investigators observed throu...
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    China to Begin Priority Reviews of Medical Devices in January 2017

    China Food and Drug Administration (CFDA) announced Thursday that its priority review and approval procedure for medical devices will come into force as of 1 January 2017. The move is part of CFDA’s implementation of reforms to its approval systems for drugs and devices, and to meet the clinical demands of medical devices. According to the law firm Ropes & Gray , the new policy, first drafted in June, will allow applicants with a Class II device (limited to importe...
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    Asia Regulatory Roundup: Australia to Adopt 10 EMA Guidelines (4 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia Starts Consultation on Planned Adoption of 10 EMA Guidelines The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on its plan to adopt 10 European Medicines Agency (EMA) guidelines. Most of the documents are replacements for existing EMA texts previously adopted by TGA, but some, such as guidelines on clinical development of drugs agai...
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    Asia Regulatory Roundup: CFDA Continues Crackdown on Dishonest Drug Manufacturers (27 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CRO Complaints About Online Portal Prompt CDSCO to Convene Meeting The Deputy Drugs Controller of India (DDCI) has convened a meeting to discuss sponsor and contract research organization (CRO) complaints about the Sugam online portal. Sponsors and CROs made the complaints after encountering problems when trying to use Sugam to apply for regulatory clearances regar...
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    Chinese and Indian Firms Warned and Banned by US FDA and German Competent Authority

    A lack of quality assurance (QA) oversight, a refusal of an inspection by the US Food and Drug Administration (FDA) and a failure to commit to any corrective actions regarding current good manufacturing practice (CGMP) violations observed on an FDA inspection landed a Chinese company an FDA warning letter, and a statement of non-compliance and a ban for two Indian companies recently. The FDA  warning letter , dated 26 July for Tianjan, China-based Concept Products Limit...
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    Asia Regulatory Roundup: CFDA Offers Guidance on Revised Vaccine Distribution Regulations (21 June 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guide to Implementing Revised Vaccine Distribution Regulations China Food and Drug Administration (CFDA) has released a guide to the implementation of its revised vaccine procurement and distribution regulations. The updated policy calls for vigilant record keeping by organizations in the supply chain and stronger regulatory oversight of each step in the pr...
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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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    Asia Regulatory Roundup: China’s Anti-Corruption Agency Chides CFDA Over Loopholes (7 June 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China’s Anti-Corruption Agency Criticizes CFDA Over Regulatory Loopholes An inspection of China Food and Drug Administration (CFDA) by the country’s anti-corruption agency has led to the publication of a litany of alleged failings at the regulator. The graft group is calling for CFDA to standardize its review, approval and inspection processes to eliminate the “many loopho...