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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...