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UNITED STATES OF AMERICA
The US Food & Drug Administration
Current Guidances
Dockets Management Homepage
Electronic Freedom of Information
Investigations Operations Manual 2006
Medical Device GMP Reference Information
Modernization Act of 1997 (FDAMA)
Center for Biologics Evaluation and Research (FDA CBER)
Center for Devices and Radiological Health
US National Institutes of Health (NIH)
National Heart, Blood, and Lung Institute
US Department of Health and Human Services
US Centers for Disease Control and prevention (CDC)
AABB Regulatory Update (Subscription Required)
ASFA Apheresis Guidelines
Circular of Information for the use of Cellular Therapy Products
Joint Commission for the Accreditation of Healthcare Organizations (JCAHO)
Health Sciences Authority
The 21CFRPart11.com
CANADA
Canada's Health Products & Food Branch
Medical Devices
Biologics
Biologics and Genetic Therapies Directorate (BGTD) Regulatory Initiatives
Blood and Blood Components Regulatory Documents
European Agency for Evaluation of Medicinal Products
The Rules Governing Medicinal Products in the European Union
European Commision
Advanced Therapies: Tissue Engineering, Cell Therapy and Gene Therapy
DG Health and Consumer Protection: Blood, Tissues, and Organs
Health and Consumer Protection Directorate General
European Directorate for the Quality of Medicines (EDQM)
SwissMedic
Council of Europe
UNITED KINGDOM
National Institute for Biological Standards & Control
Medicines and Healthcare Products Regulatory Agency
Blood Regulations
AUSTRALIA
Australian Therapeutic Goods Administration
Australian Research Council
Australian Stem Cell Centre
Guidelines for Laboratory Procedures related to the Processing, Storage and Infusion of Cells fof Transplantation or Cell Therapy
Biotechnology Australia
INDONESIA
Indonesian Ministry of Health
JAPAN
Japan's Pharmaceuticals and Medical Devices Evaluation Center
KOREA
Korean Food and Drug Administration
NEW ZEALAND
New Zealand's Medicines and Medical Devices Safety Authority
New Zealand Bioethics Council
PEOPLE'S REPUBLIC OF CHINA
National Institute for the Control of Pharmaceutical & Biological Products (in Chinese)
State Drug Administration (in Chinese)
Ministry of Health (in Chinese)
SINGAPORE
Singapore's Health Sciences Authority
Singapore Bioethics Advisory Committee Homepage
TAIWAN
Taiwan's National Laboratories of Foods and Drugs (in Chinese)
INDIA
Central Drug Standard Control Organization
World Health Organization
Medicines Policy and Standards
Global Collaboration on Blood Safety (GCBS)
Blood Products and Related Biologicals
International Society for Life Sciences Professionals: International Regulatory Information
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Regulatory Affairs Professionals Society
ISBT 128
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