National drug regulatory agencies

All actions described here are taken from the details provided by the WHO publication Quality assurance of pharmaceuticals. Volume 2, Chapter 4 Inspection of pharmaceutical manufacturers and inspection of drug distribution channels. These guidelines or other similar systems operated by national drug regulatory agencies should be followed in detail. 

The need for an inspection may be waived where an inspection report is available from inspectors representing national drug regulatory authorities for the manufacturing site under consideration, covering activities for the product(s) being prequalified, provided that the report satisfies the agency that ... 

When the preclinical testing has been completed to the satisfaction of the developer and of the national or international regulatory agency, it is time to administer the drug to man and so to launch the experimental programme that will decide whether the drug is only a drug or whether it is also a medicine. This is the subject of the next chapter. 

Following reports about the potential for herb-drug interactions, many national regulatory agencies issued warnings about the use of St. John s wort and its safety was reviewed (21,22). 

Like Indiana Jones, virtually every manufacturer of a superfruit product is hot on the trail of the Holy Grail—a health claim approved by a national regulatory agency such as the U.S. Food and Drug Administration (FDA) or European Food Safety Authority (EFSA). In simple terms, a health claim would verify that the product or compound has been scientifically proved to have a direct effect on health or the specific ability to alter the course of a disease. 

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