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    Indian Regulators, Medical Device Associations Focus on New Guidelines, Increasing Exports

    India’s Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) met with medical device association representatives earlier this month to discuss how the country can become a hub for device manufacturing and begin to align with global regulations. According to the minutes of the meeting, most of the discussion centered on increasing device exports and evaluating new guidance for industry. Draft guidance on good manufactu...
  • CDSCO Clarifies the Role of its International Unit

    India's Central Drugs Standard Control Organization (CDSCO) has posted the organizational structure and functions of its recently-formed International Cell , which interfaces with foreign governments and regulatory agencies and investigates reports of quality concerns with India drug exports.  Among its other functions, the Cell focuses on bilateral Memoranda of Understanding (MOUs), grants written confirmations for active pharmaceutical ingredient (API) exports f...
  • India issues revised draft guidance for API exports to EU

    On 7 March 2013, India's Central Drugs Standard Control Organization (CDSCO) issued revised draft guidance on the "Written Confirmation" procedure that must be implemented by India's exporters of Active Pharmaceutical Ingredients (API) to the European Union. The procedure will also be required to be implemented by the CDSCO, including its port offices. Under EU law, the CDSCO has been designated as the "Competent Authority" for India and is responsible for notifyi...
  • Brazil: Anvisa Issues New Technology Transfer Regulation for Local Companies

    Local Brazilian companies will be the beneficiaries of a new technology transfer  regulation that is intended to reduce the country's dependence on foreign drug imports and technology.  The regulation, approved by the Board of Brazil's national regulatory agency, Anvisa, on 13 September 2012, establishes procedures for local companies to enter into drug development and technology transfer partnerships with the National Health Service (SUS).  The regulatio...
  • Brazil: South American Countries Driving Regulatory Harmonization

    Brazil and Argentina are drivers of regulatory harmonization regionally in South America, said Anvisa Chief Executive Dirceu Barbano, noting the countries' efforts in the region. Both Brazil's and Argentina's respective regulatory agencies are working with Mercosur, a multilateral organization whose mission is to create a common regional market, to harmonize regulations, said Barbano. Barbano's comments were in response to questions posed by Brazilian legislators at a...