Wednesday, 9 July 2014

Key to Regulatory Affairs

World Health Organisation
The World Health Organization (WHO) is a specialized agency of the United Nations (UN) that is concerned with international public health. It was established on 7 April 1948, with headquarters in Geneva, Switzerland, and is a member of the United Nations Development Group. Its predecessor, the Health Organization, was an agency of the League of Nations.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.
The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of Medicinal Products for human and veterinary use in the European Economic Area. HMA is the common website for the human and veterinary medicines authorities in Europe.
EudraLex is the collection of rules and regulations governing medicinal products in the European Union. It gives in an overview of Pharmaceutical legislations across Europe with several directives and columes.

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