Financing drug regulation

Fees reflect costs y y lower flat rate y lower flat rate y y lower flat rate y y 

Product registration fees New product Renewal/annual retention fee Registration domestic product OTC/generic (imported) 5 000 -120 000 700 120 785 100 15 000 1 200 300 1 270 1 000 

Manufacturing Premises licence Manufacturing licence Product manufacturing licence 217-362 125 

Wholesale and retail Wholesale dealer licence/suitability of premises 71-357 40 108-180 38 

GMP inspection Licence application fee GMP inspection/other than initial 325  

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The differences found in the application of different RP systems cloud the differences between a public financing system and a price-cap regulation system. An RP becomes a price cap when the decision either to include a drug within public financing or to exclude it depends on its price. The use of RP in New Zealand and Italy is a good illustration of this situation. Italy introduced a very restrictive RP system in 1996. In this case, the maximum... 

During the second phase of pharmacy practice, health care within the U.S. experienced changes in capabilities, regulations, and financing, from the development of the pharmaceutical industry and the establishment of the Food and Drug Administration (FDA) to the creation of the first health maintenance organization (HMO). 

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