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Healthy Skepticism Library item: 8558

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Journal Article

Haines BA.
Worldwide regulations and legislation; their effects on pharmaceutical product development
Drug Development and Industrial Pharmacy 1978; 4:(1):1-30


Worldwide regulations and legislation and their effects on pharmaceutical product development are discussed. The pharmacy industry is now regulated in more than 90 countries around the world. Although the regulations all aim at proper development, testing and manufacture, they vary in each country and change from year to year. Since research and development is the area most costly to the industry, where and what type research is performed are two of the main concerns to the industry. Organizations like the European Economic Community, European Free Trade Area and the World Health Organization are striving to incorporate norms and protocol involving introduction of new drugs in order to reduce time in drug registration. Various requirements, by major countries, for drug registration, including prescription as well as O-T-C, cosmetic and veterinary products are presented The results of this legislation will eventually streamline the efforts of the world community to provide safe, efficient drug products. The future for the pharmaceutic industry is therefore largely dependent on productivity of research and development and the ability to interact favorably with regulatory agencies.


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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909