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Pharmaceutical regulation in the

Pharmaceutical regulation in the United Kingdom (UIQ has, since accession in 1973 to the European Union (EU), followed the requirements of the many directives that have been agreed in this field. Most of the pharmaceutical legislation now introduced in the UK emanates from the EU. Nevertheless, some specifically national laws still apply, and many national practices and procedures which have evolved over the yeeu s are specific to the UK. This chapter is intended to provide an overview of those key national requirements which are of particular relevcince to the pharmaceutical industry. The author has had personal experience of many of the practices, procedures, and regulations discussed nevertheless the reader is advised to consult the official texts and if necessary seek specific advice in the interpretation of current requirements. [Pg.796]

This chapter examines the missions and goals of dmg regulation, maps the present domains of dmg regulation and other government pharmaceutical fianctions, and traces the historical development of dmg regulation in the 10 countries in this study. [Pg.24]

Abbott III, T.A. (1994), Price regulation in the pharmaceutical industry prescription or placebo , Journal of Health Economics, 14, pp. 551-65. [Pg.57]

Borrell, J.R. (1999), Pharmaceutical price regulation a study on the impact of the rate-of-retum regulation in the UK , PharmacoEconomics, 15, 291-303. [Pg.233]

In addition, under the auspices of a pharmaceutical Pan-European Regulatory Forum (PERF), established by the European Commission, the EMEA administers and provides exeeutive assistance to CEEC and EU regulators in the conduet of working groups and training sessions in order to facilitate the adoption of common techni-... [Pg.67]

Each Member State of the European Union operates its own policy regarding the pricing of pharmaceutical products. In the United Kingdom, the primary tool is the Pharmaceutical Price Regulation Scheme (PPRS), which is better described as a profit-regulating scheme. This is dealt with in detail in Chapter 26. [Pg.532]

Significant challenges lie ahead for the pharmaceutical community and for regulators to move to the desired state for pharmaceutical manufacturing in the 21st century. Nevertheless, critically important steps have already been taken. [Pg.490]

This paper examines the impact of regulation on pharmaceutical innovation in the United States and the methodological problems involved when one attempts to measure pharmaceutical innovation. Data describing the rate and manner of passage of new chemical entities (NCEs) through the U.S. regulatory system and the national origin of NCEs marketed in the U.S. are presented. [Pg.127]

In 1993 Witte et al. [28] and in 1994 Rauws and Groen [29] reviewed the status of the regulation of chiral medicinal products on the pharmaceutical industries in the United States, Japan, and some European countries where designated authorities are responsible for the control and approval of newly developed drugs (both chiral and nonchiral). In the United States, new drug applications are submitted to the Food and Drug Administration (FDA), which requires appro-... [Pg.19]

The official government agency involved in regulating the pharmaceutical industry in the United States. [Pg.628]

USA, and Japan since 1990. This effort is supported by the pharmaceutical companies because it will make for more efficient regulation in the most attractive markets and will also be beneficial to patients with faster availability of new drugs. The ICH aims to eliminate duplication of assays during research and development of new drugs, as well as provide guidelines intended to unify the requirements for approval (Walsh, 2004a Foulkes and Traynor, 1999). [Pg.353]

Committee on Proprietary Medicinal Products (CPMP) A committee, composed of two people from each EU Member State (see European Union (EU) ), that is responsible for the scientific evaluation and assessment of marketing applications for medicinal products in the EU. The CPMP is the major body involved in the harmonization of pharmaceutical regulations within the EU and receives administrative support from the European Medicines Evaluation Agency. See European Medicines Evaluation Agency (EMEA). ... [Pg.15]


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