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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...
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    Asia Regulatory Roundup: CFDA Looks to Overhaul Supply Chain Controls Amid Vaccine Scandal (19 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Outlines Supply Chain Overhaul Following Vaccine Scandal The China Food and Drug Administration (CFDA) has outlined plans to overhaul regulation of the supply chain in the wake of a vaccine scandal currently engulfing the country. Officials are looking to implement a full vaccine traceability system, strengthen oversight of the cold chain and reform the centralized pr...
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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 ...
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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: India Looks to Raise Drug Inspection Standards (20 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CDSCO Creates Induction Program to Raise Standards at Inspectorate The Central Drugs Standard Control Organization (CDSCO) has set up an induction program to train assistant drug inspectors. A three-month training program, in which CDSCO will cover the regulatory framework in India and other topics, is the centerpiece of the induction strategy. CDSCO has introduced ...
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    Asia Regulatory Roundup: India Prepares to Invest in State Drug Regulators (22 September 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Sets Terms for State Regulatory Investment Plan The Indian Ministry of Health has set the terms under which it will distribute the Rs 850 crore ($129 million) state regulatory investment package. States signing up to the memorandum of understanding (MoU) will only continue to receive funding if they achieve certain predefined goals. Ministry of Health officials ha...
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    Pakistani Government Publishes New Medical Device and IVD Registration Rules

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Pakistan’s Drugs Regulatory Authority has issued new medical device and  in vitro diagnostic (IVD) regulatory requirements, the Medical Devices Rules 2015, which have gone into effect. The new  regulations  include requirements for conformity assessments, quality management systems, classification guidelines, authorized representation ...
  • Pakistan Launches First-Ever Drug Regulatory Body

    • 13 November 2012
    Pakistan has established a new drug regulatory authority in the hopes of reducing the now-rampant trade of counterfeit and substandard medicines, various news sources report. News Pakistan reports that Pakistani President Asif Ali Zardari signed into law the Drug Regulatory Authority (DRA) Bill on 12 November, which Zardari hopes will increase both the quality and affordability of medicines in the country. "The signing of this bill will ensure the availability o...
  • After Drug Deaths, Calls for Pakistan to Form Independent Drug Regulatory Authority

    Pakistan is facing calls from industry for a drug regulatory authority to be formed after a batch of cardiac drugs given to patients at a government-run hospital has been linked to more than 100 deaths. Patients at the Punjab Institute of Cardiology were given one or more drugs manufactured by relatively small, local companies . The drugs, given to roughly 40,000 patients, generated side effects that were initially confused with dengue fever. Almost 250 patients remai...