Generic medicines are those where patent protection has expired of innovator drug and which may be produced by manufacturers other than the innovator company. So for develop a new Generic drugs it should be bioequivalent to Reference drug. A standard refrence product may avoid possible significant variations among generic drug products and their brand name counterparts Reference product are regulated in different countries. In USA they are listed in Approved drug products list with therapeutic equivalence evaluation commonly known as “orange book” with the patent information. It includes all products that have been approved by FDA for safety and effectiveness, alphabetically by ingredients in the products. In Europe, reference drug is known as Reference Medicinal Product or European Reference Product. In the present article focuses on the regulation of Reference product in U.S. and Europe.
