Regulatory authorities European Union

If a product is to be exported to different countries, an understanding of the different structures and requirements set by the European Union and United States regulatory authorities is critical. 

Similar to the US requirements, there are two regulatory steps to go through before a drug is approved to be marketed in the European Union. These two steps are clinical trial application and marketing authorization application. There are 27 member states in the European Union (as of August 2007) clinical trial applications are approved at the member state level, whereas marketing authorization applications are approved at both the member state or centralized levels. 

Some regulatory authorities have foreseen the future impact of TM and set up appropriate guidelines. The European Union has legislation for traditional herbal products. Another example is the Therapeutic Goods Administration of Australia, which has set up a complementary medicine section that controls the regulatory practices for TM. 

Consequently, the environmental risk assessment (ERA) of medicinal products has to be evaluated and appropriate legislation and regulatory guidance has been issued in the European Union (EU). Recently, Directive 2001/83/EC [12], as amended by Directive 2004/27/EC [13], requires an evaluation of the potential environmental risks to be performed for every application for each active ingredi-ent/excipients from every medicinal product to be authorized. However, the... 

European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions/ ... 

In 1996, the VICH program was officially launched among the European Union, Japan, and the United States (52). Among the objectives of the VICH is to provide a forum for a constructive dialogue between regulatory authorities and the veterinary medicinal products industry on the real and perceived differences in the technical requirements for product registration in die three jurisdictions, with tlie expectation that such a process may serve as a catalyst for a wider international harmonization. VICH should identify areas in which modifications... 

This chapter will focus on some, but not all, of the areas in which the U.S. Food and Drug Administration (FDA) and the European Union (EU) regulatory authorities have attempted to coordinate their efforts to provide uniform rules and standards for the pharmaceutical industry. Specifically, we will review the efforts to harmonize approaches relating to inspections (including public disclosure of confidential information) and product approval or authorization (including clinical trials). While space limitations do not provide sufficient opportunity to describe each regulatory authority s system or the harmonization attempts in detail, it is our hope to provide some background of where the efforts are now, where the efforts are intended to go, and what we believe will be the results of these efforts. In addition, the author is much more familiar with the U.S. system than the EU system because of his experience and daily exposure with FDA, this chapter will focus more on the U.S. structure. 

A ninth chapter, guest-authored by Carl A. Rockburne, a retired Canadian trade console and regulatory consultant, compares the FDA process with those in Canada, the European Union, Japan, and Australia, the four other major regulatory environments. Fie has included FDA documents describing the regulatory harmonization process in his chapter. 

To maintain a forum for a constructive dialog between regulatory authorities and the pharmaceutical industry on differences in technical requirements for marketing approval in the European Union, the United States, and Japan in order to ensure a more timely introduction of new drugs and hence their availability to patients. 

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