Regulatory Bodies Across Globe

June 18, 2008

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

Source: Cell Therapy News


RBS issues global stock and credit crash alert

June 18, 2008

The Royal Bank of Scotland has advised clients to brace for a full-fledged crash in global stock and credit markets over the next three months as inflation paralyses the major central banks.

“A very nasty period is soon to be upon us – be prepared,” said Bob Janjuah, the bank’s credit strategist.

A report by the bank’s research team warns that the S&P 500 index of Wall Street equities is likely to fall by more than 300 points to around 1050 by September as “all the chickens come home to roost” from the excesses of the global boom, with contagion spreading across Europe and emerging markets.

Click here to read more


About REACH Compliance

June 18, 2008

REACH(Registration Evaluation and Authorisation of CHemicals legislation), the European Union regulation for the Registration, Evaluation and Authorisation of Chemicals, which entered into force on 1 June 2007, has one key central aim: to protect human health and the environment from the risks arising from the use of chemicals.

REACH has become one of the most complex and far-reaching pieces of regulation ever to originate from Brussels.

REACH intends to achieve its goal by requiring business to fully ascertain the risks posed by the use of chemicals. For certain dangerous substances this means that a company will need to define in detail exactly how to safely use a chemical.

REACH’s mechanisms is an authorisation process for substances identified as being of very high concern to human health or the environment. This will mean the hazardous chemical can only be used in ways that are authorised by a REACH central authority – the European Chemicals Agency.

But how will the agency know what chemicals require authorisation?

Much is known about certain substances but for many there are information shortfalls, which prevent a suitable risk assessment. That’s where the REACH registration process comes in-

REACH Registration

For many firms REACH registration will be the most costly and time-consuming part of compliance. Generally, anyone that makes or imports a chemical into the EU above one tonne per year will need to register it with the Agency.

Registration involves producing a dossier of information in collaboration with other manufacturers or importers. The obligations for manufacturers and importers of a substance are essentially the same.

Source: REACH compliance

Additional information can be found on the following Web sites: