Emerging Markets Regulatory Tracker: Australia, Brazil, India (Vol. 4 No. 23)
This article was originally published in PharmAsia News
Australia’s TGA proposes new warning labels for pediatric OTC cough medicines and decongestants. Brazil requires 12-month notice before withdrawing products from the market and India’s CDSCO specifies format for fixed-dose combination drug submissions.
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India’s health ministry has laid out basic steps towards an overhaul of drug regulation at the local level, identifying a number of areas of concern.
China has released the results of back on proposed standards for the accreditation of clinical trial committees, investigators and sites.
China has finalized revised rules for the classification of medical devices, which will come into effect from the start of next year.