Regulatory authorities Drug Administration

The Pharmaceutical Administration, a division in the Ministry of Health, is designated as the drug regulatory authority. The Administration handles most other regulatory affciirs issues, cis discussed in the previous chapter. The Institute for the Standardization emd Control of Phcu maceuticals of the Ministry of Health, a unit of the Pharmaceutical Administration, is responsible for issues pertaining to quality. In addition there are regional bureaus of the Ministry of Health responsible for certain aspects of related issues. 

Because the conclusions that can be reached from an LSMBS depend critically on the choice of commodities, involvement of relevant regulatory agencies [e.g., EPA, USDA, and Food and Drug Administration (FDA)] in the USA, depending on the commodity and study objective] should be considered. Agreement on the choice of commodities by such authorities will ensure that the study and its outcome will be acceptable for regulatory purposes. 

Once a decision has been made to develop a compound further following the extensive pre-clinical pharmacological and toxicological studies, approval for the first clinical studies must be sought from the regulatory authority (Medicines Board in Europe or the Food and Drug Administration in the USA). A clinical trial of a new drug is, in the words of Bradford Hill (in his Principles of Medical Statistics) ... 

The regulatory authority for approving veterinary drugs in the United States resides with the Food and Drug Administration (FDA) Center for Veterinary Medi-... 

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