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BfArM German Federal Institute for Drugs and Medical Devices
BfArM is an independent federal authority with responsibility to the Federal Ministry of Health. The aim of the authority is the prevention of dangers to public health by continuously improving the safety of medicinal products, monitoring risks from medical devices, and last but not least by monitoring the legal trade in narcotic drugs, psychotropic substances and precursors.

EMEA European Agency for the Evalution of Medicinal Products
The Agency is in charge of coordinating scientific resources within existing Member States, with a view to evaluating and supervising medicinal products for both human and veterinary use. Based on the Agency's opinions, the European Commission authorises the marketing of innovative products and arbitrates between Member States in case of any disagreement.

Eur-Lex - the portal to European Union law
The EUR-Lex website offers a comprehensive picture of EU legislation and the decision-making procedures from concept to their conclusion. The documents cover the following topics: The Official Journal of the European Communities, the treaties, legislation, legislation in preparation, case-law, parliamentary questions, documents of public interest.

FDA Food and Drug Administration Home Page
The FDA is the Federal agency charged with enforcing the US. Federal Food, Drug and Cosmetic Act and several related laws. The US Food and Drug Administration has a wide range of responsibilities for drugs, biologicals, medical devices, cosmetics and radiological products. The largest of the world's drug regulatory agencies, the FDA is responsible for the approval of all drug products used in the USA.

Heads of Agencies
This is the common Website for medicinal authorities in the European Union.

Health Canada
Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada provides national leadership to develop health policies, enforce health regulations, promote disease prevention, and enhance healthy living for all Canadians.

ICH (International Conference on Harmonization)
The International Conference on Harmonisation (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. Their purpose is to make recommendations on ways toward achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate testing carried out during the research and development of new medicines.

MCA Medicines Control Agency (UK)
The executive agency of the Department of Health responsible for safeguarding public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy. The Agency achieves its objectives through: a system of licensing before the marketing of medicines; monitoring of medicines and acting on safety concerns after they have been placed on the market; checking standards of pharmaceutical manufacture and wholesaling; enforcement of requirements; responsibility for medicines control policy; representing UK pharmaceutical regulatory interests internationally; publishing quality standards for drug substances through the "British Pharmacopoeia".

Ministry of Health, Labour and Welfare (Japan)
The Ministry of Health, Labour and Welfare is responsible for a wide range of administrative activities which encompass the following: welfare for the elderly, self reliance and rehabilitation for the disabled, healthy upbringing for children, public assistance, medical care insurance and pensions, the provision of medical care supply systems, sickness prevention and treatment, quality control of medical supplies, food hygiene, water supply, waste treatment, and relief for survivors of the war dead.

WHO (World Health Organization)
The World Health Organization (WHO) is a specialized agency of the United Nations with primary responsibility for international health matters and public health. Through the WHO, which was created in 1948, the health professions of over 180 countries exchange their knowledge and experience, working for the attainment by all citizens of the world, a level of health that will permit them to lead socially and economically productive lives.

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21 CFR Part 11 Issues
Various aspects of electronic records and electronic signatures
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