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Regulatory Bodies

International

  • World Health Organization (WHO) - Provides guidance on biotechnology, public health, and biosafety, particularly concerning infectious disease control and genetic technologies.
  • International Organization for Standardization (ISO) - Develops international standards, including standards related to biotechnology, biocompatibility, and laboratory practices.
  • Organisation for Economic Co-operation and Development (OECD) - Works on international policies for biotechnology safety, regulatory assessment, and standardization.
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Harmonizes pharmaceutical regulation, including guidelines for drug safety, efficacy, and quality.

United States

  • Food and Drug Administration (FDA) - Regulates biotechnology products, drugs, medical devices, and food safety, including molecular diagnostics and genetically modified organisms (GMOs).
  • Environmental Protection Agency (EPA) - Regulates environmental aspects of biotechnology, including GMOs, pesticides, and microbial products.
  • National Institutes of Health (NIH) - Sets guidelines for research involving recombinant or synthetic nucleic acid molecules; includes oversight through the Recombinant DNA Advisory Committee (RAC).
  • United States Department of Agriculture (USDA) - Oversees GMOs in agriculture, including plants, animals, and biopesticides.
  • Centers for Disease Control and Prevention (CDC) - Provides guidelines on biosafety practices in labs handling biological agents, especially for infectious disease research.

European Union

  • European Medicines Agency (EMA) - Regulates biopharmaceuticals and gene therapies, ensuring drug safety and efficacy across EU member states.
  • European Food Safety Authority (EFSA) - Provides independent scientific advice on food-related risks, including GMOs and synthetic biology applications in food and feed.
  • European Chemicals Agency (ECHA) - Enforces regulations on chemical substances, including biochemicals, under the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) legislation.
  • European Directorate for the Quality of Medicines & HealthCare (EDQM) - Develops standards for pharmaceuticals, including those derived from biotechnology.

United Kingdom

  • Medicines and Healthcare products Regulatory Agency (MHRA) - Regulates drugs, medical devices, and diagnostics, including molecular and synthetic biology applications.
  • Health and Safety Executive (HSE) - Oversees workplace safety and risk assessment for biotechnology research, including GMOs.
  • Advisory Committee on Releases to the Environment (ACRE) - Provides scientific advice on the release of GMOs into the environment.

Canada

  • Health Canada - Regulates biotechnology products, including drugs, diagnostics, and foods produced through genetic engineering.
  • Canadian Food Inspection Agency (CFIA) - Oversees GMOs in agriculture, including safety assessments of genetically modified crops and animals.
  • Environment and Climate Change Canada (ECCC) - Regulates environmental aspects of biotechnology under the Canadian Environmental Protection Act (CEPA).

Japan

  • Pharmaceuticals and Medical Devices Agency (PMDA) - Regulates drugs, medical devices, and regenerative medicine products, including those involving genetic engineering.
  • Ministry of Agriculture, Forestry and Fisheries (MAFF) - Oversees GMOs in agriculture, including environmental safety of genetically modified crops and livestock.
  • Ministry of the Environment (MOE) - Sets regulations for environmental biosafety and risk assessment of GMOs.

Australia

  • Therapeutic Goods Administration (TGA) - Regulates drugs, medical devices, and gene therapies.
  • Office of the Gene Technology Regulator (OGTR) - Governs the use of genetically modified organisms (GMOs) and oversees biosafety in research and industry.

China

  • National Medical Products Administration (NMPA) - Regulates drugs, medical devices, and biotechnology products, including molecular diagnostics.
  • Ministry of Agriculture and Rural Affairs (MARA) - Manages biotechnology applications in agriculture, including GMOs.
  • Ministry of Ecology and Environment (MEE) - Oversees biosafety regulations for environmental protection involving GMOs.

India

  • Central Drugs Standard Control Organization (CDSCO) - Regulates biopharmaceuticals, diagnostics, and drug safety.
  • Department of Biotechnology (DBT) - Sets guidelines for biosafety and regulates the release and usage of GMOs in research and industry.
  • Genetic Engineering Appraisal Committee (GEAC) - Approves activities involving large-scale use of genetically modified organisms in India.

Brazil

  • Agência Nacional de Vigilância Sanitária (ANVISA) - Regulates drugs, medical devices, and diagnostics, including molecular biology and synthetic biology products.
  • National Technical Biosafety Commission (CTNBio) - Oversees biosafety regulations and approves GMO research and commercialization.

South Korea

  • Ministry of Food and Drug Safety (MFDS) - Regulates pharmaceuticals, medical devices, and biotechnology products.
  • Korean Biosafety Clearing-House (KBCH) - Provides biosafety information and guidelines for GMO research and applications.