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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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    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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    Asia Regulatory Roundup: India Reverses Opposition to Off-Label Ophthalmic Use of Avastin (15 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Reverses Opposition to Off-Label Ophthalmic Use of Avastin India has quickly reversed its opposition to the off-label ophthalmic use of Roche’s Avastin (bevacizumab).  Drug Controller General of India Dr. GN Singh warned against using Avastin in ophthalmology conditions in January after reports linking it to loss of vision emerged, only to withdraw the alert th...
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    Asia Regulatory Roundup: CFDA Builds Priority Review Pathway for Drug Approvals (1 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Creates Priority Review Pathway for Cancer, Rare Disease Drugs The China Food and Drug Administration (CFDA) is creating a priority review pathway to cut the time it takes for some drugs to come to market. CFDA is aiming the initiative at products to treat certain significant illnesses and those that use advanced technology to deliver clear therapeutic benefits. In th...
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    Asia Regulatory Roundup: Drug Safety, Traceability at Forefront of China’s Health Reform Plan (16 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Puts Drug Safety and Traceability at Forefront of Healthcare Reform Program China has committed to bolstering the safety controls and traceability requirements that cover its local drug market. The commitment, which was made at a meeting of the State Council, is part of a raft of healthcare reform initiatives that are collectively intended to lessen China’s reliance ...
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    US FDA Inspections in China: An Analysis of Form 483s from 2015

    As the US becomes increasingly dependent on Chinese and Indian active pharmaceutical ingredient (API) and drug manufacturing, a deeper look into the inspection reports from the US Food and Drug Administration (FDA) in China reveals a number of question marks that parallel the same sort of issues found in Form 483s issued after inspections in India. A Focus review (thanks to use of the Freedom of Information Act (FOIA)) of eight FDA Form 483s for Chinese manufacturers i...
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    House Committee Questions FDA Oversight of China, India Manufacturing Facilities

    Members of the House Committee on Energy and Commerce are calling on the Government Accountability Office (GAO) to investigate whether the US Food and Drug Administration (FDA) is properly overseeing the pharmaceutical supply chain, particularly in China and India. Reps. Fred Upton (R-MI), Frank Pallone (D-NJ), Tim Murphy (R-PA) and Diana DeGette (D-CO) acknowledge FDA’s work on meeting the rising demands of more foreign active pharmaceutical ingredient (API) and finishe...
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    Compounders Beware: API from China May Be Contaminated, FDA Says

    The US Food and Drug Administration (FDA) late Wednesday released a warning for drug compounders that certain lots of the active pharmaceutical ingredient (API) baclofen, manufactured by China’s Taizhou Xinyou Pharmaceutical & Chemical Co., may be at risk for contamination. “FDA contacted Taizhou through its US agent, and the company confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures is not suitable for use in inje...
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    Asia Regulatory Roundup: China Pushes to Improve Generic Drug Quality (8 December 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Releases Medical Device Adverse Event Reporting Form for Consultation The Indian Pharmacopoeia Commission (IPC) has released a medical device adverse event reporting form for consultation. IPC has drafted the template as part of the drive in India to establish a materiovigilance program to monitor the safety of medical devices. Once the form is finalized, filers o...
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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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    Asia Regulatory Roundup: China FDA Seeks Comment on Generic Drug Quality Guidance (24 November 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. FIA Remands 4 Senior Pakistani Officials in Fraudulent Drug Approval Case The Federal Investigation Agency (FIA) has remanded four senior officials at the Drug Regulatory Authority of Pakistan (DRAP). FIA took the action after investigating the alleged issuance of a fake drug registration letter for a treatment for premature ejaculation. DRAP’s deputy director general o...
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    Asia Regulatory Roundup: CFDA Clampdown on Clinical Trial Data (17 November 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Trial Data Quality Drive Leads to Rejection of Applications China Food and Drug Administration (CFDA) has rejected 11 applications from eight manufacturers as part of its clampdown on the quality of clinical trial data included in submissions. The rejections come four months after CFDA began a drive to root out applications with incomplete or subpar data. None of the...