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    FOIA'd Documents Show FDA's Rationale Against Marijuana Rescheduling

    In a report and other documents obtained by Vice News via the Freedom of Information Act (FOIA) , the US Food and Drug Administration (FDA) lays out its case against rescheduling marijuana. FDA's recommendation on the matter was cited by the Drug Enforcement Administration (DEA) when it denied two petitions to reschedule marijuana last August . Despite efforts by medical marijuana advocates and a growing number of states (25, plus the District of Columbia) where med...
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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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    Asia Regulatory Roundup: Australia Looks to Establish Expedited Approval Pathway (20 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia Moves Closer to Establishing Expedited Reviews Australia has pushed its expedited review program closer to fruition by accepting the recommendations of an expert panel, which called for the creation of an expedited review pathway and an option to leverage overseas approvals when trying to bring a drug to market in Australia. Lloyd Sansom, Will Delaat and John H...
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    Asia Regulatory Roundup: TGA Offers Guidance on High-Risk IVD Online Applications (13 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Posts Guide to Online Application Form for High-Risk IVDs TGA has released a guide to using its online application form for Class 4 in-house in vitro diagnostic (IVD) devices. In keeping with recent guides created by TGA, the IVD document is a comprehensive walkthrough of the process of applying online for devices that fall into the highest-risk category. Class 4 IV...
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    Asia Regulatory Roundup: India Continues Clinical Trial Reform Agenda (6 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Draft Guidance on Recalls of Medical Devices China Food and Drug Administration (CFDA) has released draft guidance on the recall process for medical devices. The text establishes who is responsible for detecting possible defects with medical devices, the process for alerting users of a fault and the penalties CFDA will hand out to companies that fail to mee...
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    Asia Regulatory Roundup: CFDA Revises Preclinical Guidance (23 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Revises Guidance on Preclinical Studies China Food and Drug Administration (CFDA) has released revised draft guidance on preclinical studies for consultation. The text sets out CFDA’s expectations for the gamut of factors that go into running preclinical studies, from the skills and responsibilities of laboratory staff to the design of facilities. CFDA established i...
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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 Fast Tracks Hepatitis C, Cancer Drug Approvals (26 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Puts Hepatitis C, Cancer Drugs on Regulatory Approval Fast Track China has granted priority review status to a clutch of drugs being developed by Western companies. The products affected by the actions include the expensive hepatitis C drugs from Gilead Sciences and other manufacturers that have transformed treatment of the disease in the West. Versions of Gilead’s b...
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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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    Asia Regulatory Roundup: India Taxes Cancer, HIV Drug Imports (9 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Imposes Tax on Imports of Cancer and HIV drugs India has stopped exempting more than 70 drugs from customs duties. The ruling means companies that import any of the products or manufacture them within special economic zones will have to pay more tax, potentially giving local producers an advantage over foreign businesses. Officials at the Central Board of Excise and...
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    Asia Regulatory Roundup: Pharmacy Sues CFDA Over Drug Monitoring System (2 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Pharmacy Sues CFDA Over Alibaba Electronic Drug Monitoring System Yontinhe Group has filed a lawsuit against the China Food and Drug Administration (CFDA). The case relates to an electronic drug monitoring system that CFDA introduced in 2013 in collaboration with a subsidiary of the Chinese tech giant Alibaba. CFDA and Ali Health, the Alibaba subsidiary, purportedly ...