Pharmaceutical Research Industry Essay Example
The current drug innovation environment has many challenges including political, economic and regulatory issues. The pharmaceutical research industries continue to use slow and expensive processes that are inefficient in delivering the required products that the market needs. The sector is characterized by stringent regulations, patent expirations, and constant pressure from sponsors to show that their drugs provide economic and or therapeutic value. The companies also have to develop drugs from discovery to products in the market. The complexities of the process make it risky, time-consuming and a costly affair. Recently, the pharmaceutical industry has experienced some changes by aligning strategic performance objectives with operational objectives. The new model in the industry involves moving from the R&D model to the FSP relationships and alliances. The whole system becomes a network with academic centers to provide basic research and translational medicine as well as small pharmaceutical companies.
There has been the need for the development of globally harmonized science-based standards in the development and evaluation of medical products. Many firms in the world are involved in the development of different drugs, but some especially in the developing world do not follow strict standards. The Institute of Medicine has a forum that focuses on the discovery of drugs, their development, and their translation into the market. The forum focuses on having efficient processes of developing new drugs including supporting clinical trials. Harmonized standards will reduce duplication of effort that is costly, optimize the use of limited resources, support experience, and knowledge sharing and reduce the number of clinical trials. However, harmonization faces the challenge of the different regulatory capacity and expertise that exists in the various countries.
Is total international harmonization in the pharmaceutical industry possible considering the different standards and regulations present in different countries?
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