Pharmaceutical research-based manufacturers

According to pharmaceutical research-based manufacturers (PhRMa), the representative body of the research-based pharmaceutical companies (3), in 2003, PhRMa member companies invested an estimated 33.2 billion in research to develop new treatments for diseases—an estimated 17.7% of domestic sales on R D—a higher R D to sales ratio than any other U.S. industry, which averages around 4% of sales (3). 

A guideline for evaluation of the photostability of new drug substances and dosage forms was published in 1997 [39]. Subsequently, a joint study was undertaken by the U.S. Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America to evaluate the ICF1 guideline. A draft chapter for the United States Pharmacopeia, based on the guideline and the joint study, has been published in Pharmacopeial Forum [40]. 

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). 

Figure 1.2 R D investments by research-based US pharmaceutical companies. Source. The Pharmaceutical Research and Manufacturers of America (PhRMA). Pharmaceutical Industry Profile 2006. http //www.phrma.org/files/2006%20Indusry%20 Profile.pdf, and http //www.phrma.org/news room/press releases/r%26d spending by u.s. biopharmaceutical companies reaches a record %2455.2 billion in 2006/ [accessed July 7, 2007].

Further examples of R D investments into drug research by research-based US pharmaceutical companies from 1980 to 2006 are shown in Fig. 1.2. The enormous spending on R D has escalated in recent years. According to reports by The Pharmaceutical Research and Manufacturers of America (PhRMA), US pharmaceutical companies have almost doubled their R D spending every five years since 1980. Out of every five dollars earned in sales, a dollar is put back into R D. In 2006 the US pharmaceutical industry spent 55.2 billion to develop new drugs. 

PhRMA (2003), A Risk-Based Approach to cGMPs, White Paper, Pharmaceutical Research and Manufacturing of America. 

Germany is the home of some major multinational pharmaceutical companies such as Aventis, BASF, Bayer, Boehringer Ingelheim, Merck KGaA, and Schering AG. VFA is the research-based manufacturers association, whereas the Bundesverband de Pharmazeutischen Industrie (BPI) represents small and medium-sized companies. Because North America is the largest pharmaceutical market in the world, many of the VFA pharmaceutical companies locate their key operations in the United States. Exports to Western European countries represent a major source of income for many of the German pharmaceutical companies. 

Pharmaceutical Research and Manufacturers of America (PhRMA) The PhRMA represents the research-based industry in the United States. The Association has 67 companies in membership, which are involved in the discovery, development and manufacture of prescription medicines. There are also 24 research affiliates that conduct biological research related to the development of drugs and vaccines. 

The Pharmaceutical Research and Manufacturing Affiliates (PhRMAG) was founded in 1999, and is based in Dubai (UAE). Its objective is to represent the pharmaceutical industry in dialogue with governments in healthcare issues and to communicate the value of innovation and research. Its membership is mainly the Middle East affiliates of European and American pharmaceutical companies that are active in the five Gulf States (Kuwait, Bahrain, Qatar, UAE and Oman). 

The Pharmaceutical Research and Manufacturers of America (PhRMA), 1100 Fifteenth Street, NW, Washington, DC 20005. U.S.A. Phone +1 202-835-3400, Fax +1 202-835-3414. URL http //www.phrma.org. PhRMA represents the leading research-based pharmaceutical and biotechnology companies in the United States. It serves as the political arm of the pharmaceutical industry and seeks to influence public health... 

The six parties that are the founding members of ICH and directly involved in the decision-making process represent the regulatory bodies and the research-based industry in the European Union, Japan, and the USA, the three regions where the majority of new drugs are developed. They are the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products and the European Federation of Pharmaceutical Industries and Associations in the EU, the Ministry of Health, Labour and Welfare and Japan Pharmaceutical Manufacturers Association in Japan, the Food and Drug Administration and Pharmaceutical Research and Manufacturers of America in the USA. 

PhRMA is a trade association of over 100 research-based pharmaceutical companies. For membership a company must manufacture and market finished dosage-form products under its own brand names and must conduct a significant amount of research and development in the United States. 

The JPMA represents 90 member companies. Its membership includes aU the major research-based pharmaceutical manufacturers in Japan. 

The IFPMA is a federation of member associations representing the research-based pharmaceutical industry and other manufacturers of prescription medicines in 56 countries throughout the world. The IFPMA has been closely associated with ICH since its inception to ensure contact with the research-based industry, outside the ICH regions. Based in Geneva, Switzerland, it serves as the ICH Secretariat. 

Japan Pharmaceutical Manufacturers Association (JPMA) The key objective of JPMA is the development of a competitive pharmaceutical industry with a greater awareness and understanding of international issues. Over ninety companies are members, including all the major research-based pharmaceutical manufacturers in Japan. ICH work is coordinated through specialized committees of industry experts. JPMA promotes and encourages the adoption of international standards by its member companies. 

The International Federation of Pharmaceutical Manufacturers Associations (IFPMA). IFPMA represents the worldwide research-based pharmaceutical industry and facilitates the development of position statements on policy issues. It serves as a bridge between industry, the WHO, and other international health agencies. It also serves at the ICH secretariat. 

Virtual companies are based on the premise that core competencies within chemical and pharmaceutical companies he in discovery research and not in development. There are many contract research and manufacturing companies who do have the necessary skills for the product development process and the job of the virtual company is to access these skills and then utilise them in an efficient way. The hub in which such a virtual pharmaceutical company operates is illustrated in Figure B9. 

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