Regulatory agencies in Europe

Founded in 1990, the International Conference on Harmonization (ICH) is comprised of the pharmacopeial manufacturers associations in Europe (EFPIA), Japan (JPMA), the United States (PMA), and the drug regulatory agencies in Europe (EEC), Japan (MHW), and the United States (FDA), with the International Federation of Pharmaceutical Manufacturers Association (IFPMA) serving as secretariat. Pharmacopeias are not members of the ICH, where membership is reserved for three PMAs and three regulatory agencies. Invited observers include Canada, WHO, and the European Free Trade Association (EFTA). 

From the regulatory perspective, ICH has created a strong process for providing valuable guidelines to aid a manufacturer to set consistent specifications that will be accepted by regulatory agencies in the three major pharmaceutical marketplaces—the United States, Europe, and Japan. ICH guidelines include ... 

V itravene, a phosphorothioate oligonucleotide designed to inhibit cytomegalovirus-induced retinitis, has been shown to be safe and effective in the treatment of this disease after in-travitreal injection and has been approved for sale by regulatory agencies in the United States, Europe, and South America (for review, see Ref 240). 

This mechanism should pertain to individuals otherwise at risk of thrombosis, such as those with rheumatoid arthritis, as the relative risk of myocardial infarction is increased in these patients compared to patients with osteoarthritis or no arthritis. The incidence of myocardial infarction and stroke has diverged in such at-risk patients when COX-2 inhibitors are compared with tNSAIDs. Placebo-controlled trials have now revealed an increased incidence of myocardial infarction and stroke in patients treated with rofecoxib, valdecoxib, and celecoxib, consistent with a mechanism-based cardiovascular hazard for the class. Regulatory agencies in the U.S., Europe, and Australia have concluded that all three drugs increase the risk of heart attack and stroke and will be labeled accordingly and restricted with respect to marketing directly to consumers. Only celecoxib remains on the market in the U.S. 

Second, there are major differences between the United States and Europe in the extent of pre-regulatory studies undertaken. Because of the U.S. requirement on agencies like the U.S. Environmental Protection Agency to conduct a Regulatory Impact Analysis before taking action, substantially more information was available about the hoped-for benefits of U.S. policies. A further issue concerns the greater reliance on taxes for regulatory purposes in Europe compared to the United States. A number of European nations use such taxes—sometimes combined with incentive compatible rebate schemes—to achieve environmental objectives. 

The European Medicines Agency (EMEA) is a decentralized body of the European Union created with the objective to harmonize regulatory activities in Europe. EMEA began its activities in 1995, when the European system for authorizing medicinal products was introduced, providing for a centralized and a mutual recognition procedure. Its main responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines for human and veterinary use. 

Is the colorant approved for use in the country in question To be used in the United States, the colorant would need to be registered with the Enviromnental Protection Agency (EPA) to be put on the TSCA (Toxic Substance Control Act) list or be exempted from approval. In the European Economic Community, the substance would need to be on the European Inventory of Existing Chemical Substances (EINECS) [54] or the European List of Notified Chemical Substances (ELINCS) [55]. The chapter by Knight gives an excellent summary of the current state of regulatory affairs in Europe, North America, and the Pacific Rim countries [56]. 

The World Health Organization (WHO) is a specialized agency of the United Nations. There are 193 member states as of January 2008. The WHO is headquartered in Europe with four regional offices in Africa, the Americas, the Eastern Mediterranean, Southeast Asia, and the Western Pacihc. The WHO is not a regulatory agency. Its functions are ... 

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