Future perspectives of regulations — industry viewpoint
New medicines development is time consuming and expensive. Regulatory review time is only part of the time taken to develop new products. However, since regulatory review is a key part of the process every effort should be made to make it as efficient as possible.
In the United States the Food and Drug Administration (FDA) have recently implemented two Action Plans to increase the efficiency of the regulatory process. Various co-operative measures have been instituted but because it takes many years to make a large government agency more efficient, the average NDA approval times are barely improved as yet. Further study of the regulatory process is warranted to identify additional areas for improvement.
A number of changes have been made by the Japanese Ministry of Health and Welfare to regulations for new medicines development. However, there is room for improved harmonization with other regulatory requirements, in the areas of pre-clinical data, phase III trials and combination drugs.
It is possible that, with the effort to establish a free market for pharmaceuticals, European Community procedures could diverge from the direction in which the Unites States and Japan are proceeding.
Since increasing the efficiency of modern medicines development can contribute to the improved well-being of mankind, in terms of mortality, morbidity and health-care costs, improving any part of the development process — such as regulatory review — is an important and worthwhile task.
KeywordsAcute Rheumatic Fever Regulatory Review Fungal Keratitis Medicine Development Trained Reviewer
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