Health Authorities of International Reference

Some national health authorities and other international entities are considered relevant for the pharmaceutical industry around the whole world. For example, the American Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are actively involved in the vanguard of the pharmaceutical field, by designing guidelines, working in partnership with companies and associating with each other to discuss current issues and harmonize recommendations and requirements. (see International Conference on Harmonization…)

Many health authorities around the world ask, as an absolute requirement or as a way to expedite registration procedures, that pharmaceutical and other medical products are registered and/or marketed in what they call “high sanitary surveillance” countries, which are generally those more industrialized, with more evolved regulations and great scientific capacity of the regulators. Generally, this list of “trusted countries” include the US, Japan, Australia, European countries. (individually or as a block through EMA)

Another international entity to be considered is the World Health Organization. Based in Geneva, Switzerland, is the agency of the United Nations dedicated to health issues. It is very relevant to the pharmaceutical industry, as it is also developer of some incumbent guidelines and recommendations (for example, on stability studies) and because it overall directs the concerted efforts of most countries in the world on health matters.


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