The Globalization of Pharmaceutical Regulation

Abstract

Drugs have long been among the most extensively regulated of all consumer products. Not only do all governments closely supervise virtually every aspect of their development, testing, production and marketing, but many also regulate their pricing and distribution. The pharmaceutical industry is highly globalized, with over half the sales of the fifty largest drug companies made outside their home country (Tarabusi and Vivkery 1993). However, until recently, drug regulation was virtually synonymous with national sovereignty. Firms were required to conduct separate tests, submit separate applications, and meet distinctive criteria to enter each national market. Because drugs are so extensively regulated and have such significant health and safety impacts, drug policy coordination has proven extremely difficult. Nonetheless over the last decade, national regulatory agencies have begun to cooperate more closely with one another. The European Union has established a centralized drug approval system, the United States Food and Drug Administration has become more willing to cooperate with its foreign counterparts, and the United States, the EU and Japan have made substantial progress in harmonizing drug approval requirements under the auspices of a new international body, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products (ICH). This article describes and assesses the implications of the increase in international coordination of national drug approval policies. It argues that the undermining of national regulatory sovereignty has improved both the effectiveness and efficiency of government regulation.

Supranational regulatory agencies between independence and control: the EMEA and the authorization of pharmaceuticals in the European Single Market

“…These standards constitute the principal instrument of the EMEA to inform possible applicants of the precise criteria upon which its scientific opinions are based (interviews at EMEA headquarters and at the German pharmaceutical authority [Bundesamt für Arzneimittel und Medizinprodukte]). They are elaborated by various working groups of the expert committee or emerge from the international conference on harmonization (ICH) founded by the United States, Japan and the EU to harmonize their national (or supranational) authorization of medicinal products (Vogel 1998). As of 1 June 2003, 146 Guidelines were in force, while twenty-four were in a draft stage, and twenty-three in the preceding conceptual stage.…”

“…Others argue that the quasi-independence of the agency supports the quality of regulatory decision-making (e.g. Majone and Everson 2001;Vogel 1998), and yet others, taking agency independence for granted, criticize the arrangement because of its lack of effective control which might foster a neocorporatist bias in favour of industry interests (e.g. Abraham and Lewis 2000: 147-71).…”

Investigating inspection practices of pharmaceutical manufacturing facilities in selected Arab countries: views of inspectors and pharmaceutical industry employees

“…Academic literature addressing pharmaceutical inspection processes within the developing world are scarce, despite an increasing trend toward the globalization of pharmaceutical regulation [21,22]. There is commentary suggesting a lack of trained personnel and significant barriers to ensuring inspection processes are consistent within and across several developing countries.…”

A framework for the evaluation of new interventional procedures

“…[3][4][5] This contrasts with pharmaceuticals, which are subjected to rigorous assessment before they are routinely used in patients. [6][7][8];…”