The WHO Certification Scheme and International Pharmaceutical Product Marketing

| 01 June 2008

The World Health Organization (WHO) is the United Nations' leading regulatory authority for international public health. According to WHO, access to essential and quality medicines is a basic human right.1 Because of the unique way the pharmaceutical industry impacts human health and well-being, WHO plays an important role in regulating international drug approval and marketing. Quality, safety and efficacy (QSE) are the fundamental requirements for marketing a drug in any country. Any new drug must meet adequate quality standards and have sufficient clinical evidence to demonstrate its safety and effectiveness before it can enter the market.2 New drug approval is a highly complex process that requires a high level of expertise and resources, and large, well-trained, experienced multidisciplinary teams with the capability to review and evaluate all aspects of new products. Only a few regulatory agencies, mainly in welldeveloped, industrialized countries, are competent to effectively evaluate new drugs to assure their quality, safety and efficacy.


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