REGULATORY BODIES

NORTH AMERICA | EUROPE | UNITED KINGDOM | ASIA & PACIFIC | INTERNATIONAL

NORTH AMERICA

UNITED STATES OF AMERICA

The US Food & Drug Administration
Home Page
Current Guidances
Dockets Management Homepage
Electronic Freedom of Information
Investigations Operations Manual 2006
Medical Device GMP Reference Information
Modernization Act of 1997 (FDAMA)
References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies (OCTGT)

CANADA

Health Canada Drugs and Health Products
Home Page
Biologics and Genetic Therapies
Biologics and Genetic Therapies Fact Sheet

EUROPE

European Medicines Agency
Homepage
Gene Therapy Expert Working Group

European Commision
Proposal for a Harmonised Regulatory Framework on Human Tissue Engineered Products: DG Enterprise Consultation Paper

UNITED KINGDOM

National Institute for Biological Standards & Control:
Homepage

Medicines and Healthcare Products Regulatory Agency:
Homepage


ASIA & THE PACIFIC

AUSTRALIA

Australian Therapeutic Goods Administration
Australian Research Council
Australian Stem Cell Centre
Biotechnology Australia

INDONESIA

Indonesian Ministry of Health

JAPAN

Japan's Pharmaceuticals and Medical Devices Evaluation Center

KOREA

Korean Food and Drug Administration

NEW ZEALAND

MedSafe
New Zealand Bioethics Council

PEOPLE'S REPUBLIC OF CHINA

National Institute for the Control of Pharmaceutical & Biological Products (in Chinese)
State Food and Drug Administration (in Chinese)
Ministry of Health (in Chinese)

SINGAPORE

Singapore's Health Sciences Authority
Singapore Bioethics Advisory Committee Homepage

TAIWAN

Bureau of Food and Drug Analysis

INDIA

Central Drug Standard Control Organization:

INTERNATIONAL

World Health Organization
Quality Assurance and Safety of Medicines

International Society for Cellular Therapy
International Society for Cellular Therapy: Regulatory Affairs Europe
International Society for Cellular Therapy: Regulatory Affairs North America

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)
Topics and Guidelines

Regulatory Affairs Professionals Society
Home Page
Combination Products Resource Page

The 21CFRPart11.com
Provides access to information on the rules and also maintains an email list that actively discusses issues and concerns with industry peers and government regulators.
Homepage