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Pharmaceutical regulatory agencies and ICH guidelines were discussed. Regulatory authorities for each country were listed

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Dr. Useni Reddy Mallu Mobile: 7901020060 E-mail: info@manasalifesciences.com Website: www.manasalifesciences.com Pharmaceutical Industry Regulatory Agencies
Regulatory Agencies
ICH  International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH)  The birth of ICH April 1990  Europe, Japan and the US met
ICH guidelines
ICH Quality Guidelines
ICH Safety Guidelines
ICH Efficacy Guidelines
ICH Multidisciplinary Guidelines
Regulatory Agencies Country Name of Regulatory Authority USA  Food and Drug Administration (FDA) UK Medicines and Healthcare Products Regulatory Agency (MHRA) Australia  Therapeutic Goods Administration (TGA) India  Central Drug Standard Control Organization (CDSCO) Canada  Health Canada Europe European Medicines Agency (EMEA) Denmark Danish Medicines Agency Costa Rica Ministry of Health New Zealand Medsafe - Medicines and Medical Devices Safety Authority Sweden Medical Products Agency (MPA) Netherlands Medicines Evaluation Board Ireland Irish Medicines Board Italy  Italian Pharmaceutical Agency Nigeria  National Agency for Food and Drug Administration and Control (NAFDAC) Ukraine  Ministry of Health Singapore Centre for Pharmaceutical Administration Health Sciences Authority Hong Kong Department of Health: Pharmaceutical Services Paraguay Ministry of Health Sweden Medical Products Agency (MPA) Thailand  Ministry of Public Health China State Food and Drug Administration Germany Federal Institute for Drugs and  Medical Devices Malaysia National Pharmaceutical Control Bureau,Ministry of Health Pakistan Drugs Control Organization, Ministry of Health South Africa Medicines Control Council Sri Lanka SPC,Ministry of Health Switzerland Swissmedic  , Swiss Agency for Therapeutic Products Uganda Uganda National Council for Science and Technology (UNCST) Brazil Agencia Nacional de Vigiloncia Sanitaria (ANVISA ) Japan Ministry of Health, Labour & Welfare(MHLW)
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Regulatory agencies manasa life sciences

  • 1. Dr. Useni Reddy Mallu Mobile: 7901020060 E-mail: info@manasalifesciences.com Website: www.manasalifesciences.com Pharmaceutical Industry Regulatory Agencies
  • 3. ICH  International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH)  The birth of ICH April 1990  Europe, Japan and the US met
  • 9. Regulatory Agencies Country Name of Regulatory Authority USA  Food and Drug Administration (FDA) UK Medicines and Healthcare Products Regulatory Agency (MHRA) Australia  Therapeutic Goods Administration (TGA) India  Central Drug Standard Control Organization (CDSCO) Canada  Health Canada Europe European Medicines Agency (EMEA) Denmark Danish Medicines Agency Costa Rica Ministry of Health New Zealand Medsafe - Medicines and Medical Devices Safety Authority Sweden Medical Products Agency (MPA) Netherlands Medicines Evaluation Board Ireland Irish Medicines Board Italy  Italian Pharmaceutical Agency Nigeria  National Agency for Food and Drug Administration and Control (NAFDAC) Ukraine  Ministry of Health Singapore Centre for Pharmaceutical Administration Health Sciences Authority Hong Kong Department of Health: Pharmaceutical Services Paraguay Ministry of Health Sweden Medical Products Agency (MPA) Thailand  Ministry of Public Health China State Food and Drug Administration Germany Federal Institute for Drugs and  Medical Devices Malaysia National Pharmaceutical Control Bureau,Ministry of Health Pakistan Drugs Control Organization, Ministry of Health South Africa Medicines Control Council Sri Lanka SPC,Ministry of Health Switzerland Swissmedic  , Swiss Agency for Therapeutic Products Uganda Uganda National Council for Science and Technology (UNCST) Brazil Agencia Nacional de Vigiloncia Sanitaria (ANVISA ) Japan Ministry of Health, Labour & Welfare(MHLW)