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    Dramatic Drop in Hydrocodone Combo Prescriptions After DEA Rescheduling

    Prescriptions for hydrocodone combination products (HCPs) fell significantly after the US Drug Enforcement Agency (DEA) tightened restrictions on those drugs, according to a study published Monday in JAMA Internal Medicine . For years the US has been in the grips of a prescription drug abuse epidemic, in part driven by the availability of hydrocodone and other opioids such as oxycodone, codeine and methadone. In 2013, more than 200 million prescriptions for opioids we...
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    Asia Regulatory Roundup: CFDA Begins Overseas Inspections (26 January 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Warns Indian, Japanese Manufacturers as Overseas Inspection Drive Begins China Food and Drug Administration (CFDA) has found fault with the manufacturing practices of four foreign drugmakers, the highest profile of which is India’s Aurobindo Pharma. The regulator framed the warnings as part of an initiative to step up its oversight of companies that are importing ...
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    Asia Regulatory Roundup: Dengue Vaccine Nears Approval in India Without Local Phase III Data (19 January 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Sanofi Secures Indian Committee Approval for Dengue Vaccine Without Local Phase III Data An Indian drug regulatory committee has recommended allowing Sanofi to bring its Dengue vaccine to market without first generating Phase III data in a local trial. The committee thinks the divergence from normal protocol is acceptable given the scale of the health threat posed by the D...
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    Asia Regulatory Roundup: India Pushes Back Track and Trace Deadline Again (12 January 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Moves Back Deadline for Implementation of Track and Trace India has pushed back the deadline by which manufacturers must comply with aspects of its system to track and trace drug exports. Having originally set a deadline of July 2015, the government has now once again delayed the date on which the export monitoring system must be implemented. The Directorate Genera...
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    FDA: Explosions at Chinese Chemical Warehouse Contaminated Drugs

    The US Food and Drug Administration (FDA) on Tuesday alerted compounders and drug manufacturers that shipments from Tianjin, China may be at risk of chemical contamination following two massive explosions in August at a chemical warehouse there. The agency has already detected hydrogen cyanide contamination in two shipments of drugs from Tianjin-based Tianjin Tianyao Pharmaceuticals Co., approximately 30 kilometers (18 miles) from the explosion site. The contaminated sh...
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    Asia Regulatory Roundup: China Looks to End Regional Variation in Trial Oversight (22 December 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Pushes to End Regional Variation in Strength of Clinical Trial Oversight The China Food and Drug Administration (CFDA) has committed to ending region-to-region variation in the strength of clinical trial oversight as it’s found that some regions are failing to comply with the more rigorous approach to clinical trial inspections and data quality. CFDA began its clam...
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    Asia Regulatory Roundup: CFDA Chips Away at Backlog of Applications (15 December 2015)

    Welcome to our Asia Regulatory Roundup, a weekly overview of the top regulatory news in Asia . Fresh Batch of Withdrawals and Rejections Chips Away at CFDA Backlog China Food and Drug Administration (CFDA) has wiped almost 150 drug filings from its backlog. Most of the applications were pulled by the companies themselves, with CFDA only actively rejecting 13 of the submissions. The withdrawals affected 131 filings by 82 companies. CFDA put pressure on companies ...
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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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    PIC/S Elects New Chairman, Adds Croatia’s HALMED as Participating Authority

    The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has elected Paul Hargreaves of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) as its new chairman for 2016 and 2017. Hargreaves, elected at a meeting in Indonesia last month, will be the fourth PIC/S chairman from the UK and he will follow the departure of Joey Gouws, acting head of South Africa’s Medicines Control Council, who was the first PIC/S chairperson from Africa.   Following the succe...
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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...
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    Asia Regulatory Roundup: AHWP to Harmonize Device Submissions in Asia (10 November 2015)

    AHWP Releases Guidance on Harmonizing Medical Device Submissions in Asia The Asian Harmonization Working Party (AHWP) has posted guidance on the preparation of a common submission dossier template for the region. AHWP views the guidance as a step toward eliminating the need for medical device manufacturers to create individually formatted dossiers for submission in China, India and its other member countries. As it stands, companies pursuing the approval of medical de...