Pharmaceutical industry Union

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

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. 

Compound libraries may be bought and sold individually. After the dissolution of the Soviet Union in 1991, laboratories that had been formerly well funded by the Soviet government suddenly became essentially broke. As a means of generating funds, some research groups began to sell portions of their in-stock compounds. The samples were readily purchased by Western companies, including the pharmaceutical industry. The value of the compounds depends on the novelty of the structures and their purity. 

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. 

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. 

The separation selectivity of a mixture of acidic, basic, and neutral compounds can be altered with the addition of chaotropic mobile-phase additives (Figure 4-62). The retention of the basic compounds can be increased by addition of chaotropic counterions in the mobile phase, while the retention of neutral and acidic compounds is generally unaffected. This is particularly useful during the development of impurity profile methods in the pharmaceutical industry where the retention of a polar protonated basic impurity may be adjusted such that adequate separation selectivity is obtained when union-izable, acidic, or basic (in neutral form) impurities in the drug substance are present. In Figure 4-62 the retention of protonated basic compounds, metoprolol and labetalol, increase while the retention of phenol (in its neutral state) remains constant. 

Examples are EU and/or FDA for a pharmaceutical industry selling products to the European Union and the United States, respectively EPA for environmental issues in the United States, military, hospital, and nuclear standards for these industries. Some standards are voluntary, e.g., standardization/accreditation programs such as ISO. Here the industry has asked for a certification or accreditation according to the standard. There may also be internal standards in any company based on a combination of external standards and internal standards. 

Requirements for the pharmaceutical industry, at least in the United States and the European Union, is that the system shall be developed in a quality environment. The FDA does not accept any certification, including ISO 9001, as a replacement for your own audit. The reason is that the development of the system shall be according to your requirements, not according to someone else s. The conclusion is that the organization needs to perform its own vendor audit. The explanation on how to perform a vendor audit can be found in the literature. The result from the audit shall be a factor in the selection of the system. 

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. 

The ICH Committee consists of the European Commission of the European Union (EU), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Ministry of Health and Welfare, Japan (MHW), the Japan Pharmaceutical Manufacturers Association (JPMA), the U.S. 

The effectiveness of various measures to contain expenditure on medicines in the UK can only be assessed in the context of the situation in other European Union countries. Table 21.1 gives data for the total expenditure on health care as a percentage of gross domestic product (GDP), expenditure on medicines as a percentage of total healthcare spend, the national pharmaceutical industry s research and development expenditure in euro-millions, the general price index and the medicines price index nationally compared to a European price of 100, and the national pharmaceutical consumption per capita expressed as defined daily doses (DDD). These comparisons are based on OECD Health Data 2000. 

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