European Union pharmaceutical industry

European Union European Commission (2) European Federation of Pharmaceutical Industries Associations (2)... 

There are six parties directly involved in ICH as well as observers and the International Federation of Pharmaceufical Manufacturers Association (IFPMA see Table 25.1). The six parties are the founder members of ICH, and fhey represenf fhe regulatory bodies and the research-based industry in the European Union (EU), Japan, and the United States in the EU, the European Federation of Pharmaceufical Indusfries and Associations (EFPIA) and the Ministry of Healfh, Labour, and Welfare (MHLW) in Japan, the Japan Pharmaceutical Manufacturers Association (JPMA) and in the United States, the FDA and the Pharmaceutical Researchers and Manufacturers of America (PhRMA). 

There are slight differences in the requirements for the European Union, the United States, and Japan. Duration to support Phase III trials in the EU, when they differ from the other data, is given in parentheses. Readers are referred to Guidance for Industry M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, EDA, Rockville, MD, 1997. http //www.fda.gov/cder/guidance/1855fnl.pdf [accessed September 20,2007]. 

From this and other guidelines have developed current principles of good clinical practice ( GCP ) centred on ethical review by committee, with a favourable opinion being at least a moral precondition of the commencement of any human research project. In 1989, the CPMP (the Committee for Proprietary Medicinal Products) adopted GCP guidelines (based on a previous 1987 version) for the European Union. Although they were not in themselves legally enforceable, the pharmaceutical industry saw compliance with the guidelines... 

In general, the pharmaceutical industry would regard the freedom to price new products without awaiting the outcome of protracted negotiations - that can delay marketing for months or even years in some European Union countries - as a major advantage that counterbalances the system s many faults. This freedom was maintained in the 1999 revision of the PPRS. 

European Commission. The Rules Governing the Medical Products in the European Union, Volume 4, Good Manufacturing Practices. Brussels Directorate General BI—Industry, Pharmaceuticals and Cosmetics (1998). 

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. 

Harmonization of regulatory requirements was pioneered by the European Community (now the European Union) in the 1980s, as it moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonization was feasible. The harmonization process was then extended to include Japan and the United States. The ICH was formed from a government body and an industry association from each of these regions. These bodies and associations as listed by Molzon (2006) are ... 

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. 

The regulatory framework governing biological medicinal products is based on the European Community Treaty, which aims at the free movement of goods within the European Union. Although the legal base is built on the principle of free trade of medicinal products within the European Union, the essential aim of any rules governing the production, distribution, and use of medicinal products must be firmly based on protection of public health. Recital 3 of Directive 2001/83/EC notes that the objective of public health protection must be attained by means that do not hinder the development of the pharmaceutical industry or trade in medicinal products within the European Union. 

Similar approaches were adopted by major regulatory authorities in other countries, including the United Kingdom, France, Germany, Italy, and Scandinavia and subsequently the European Union. The official agencies and the pharmaceutical industries own experts have published recommendations for a wide range of types of toxicity tests to provide comprehensive data in stardardized form for assessment. 

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