International Generic Pharmaceutical

That argument was first famously raised by the then U.S. FDA Commissioner Mark McClellan before the First International Colloquium on Generic Medicine in Cancun, Mexico (September 25, 2003). It was raised again by the Republican Policy Committee of the United States Senate (2005). Its policy statement, Pharmaceutical Price Controls Abroad An Unfair Trade Policy, cited the 2002 U.S. Trade Promotion Authority Act, which acknowledged that price controls and reference pricing for pharmaceutical products (to be discussed below) are trade-distorting... 

Saha, Atanu, Henry Grabowski, Howard Birnbaum, Paul Greenberg, and Oded Bizan. 2006. Generic Competition in the U.S. Pharmaceutical Industry. International Journal of the Economics of Business 13(1) 15-38. 

In the fine chemicals and pharmaceutical sectors lower labour rates, increased local demand and acceptance of international standards in quality management are also taking manufacturing away from Europe and the US. India has become the no.l manufacturer of the APIs for generic drugs 70% of all such APIs used in Europe are now manufactured in India and China. 

Bulk manufacturing of therapeutic products in New Zealand is minimal the majority of products are imported from overseas, particularly from Europe, the United States and Australia. There are, however, a number of manufacturers of generic medicines who service the internal market, as well as export to Australia, the South Pacific and the growing pharmaceutical markets of Southeast Asia. 

There are no transparent regulations for accelerated procedures or abridged requirements for OTC or generic products this fact has been criticised by the Polish and international pharmaceutical products producers (Scrip Nov. 1996). 

The doctor s prescription must identify the generic by the common international name or by the generic name, followed by the dosage and pharmaceutical form. 

The need for standard operating procedures regarding the bioequivalence studies cirose when the SPLC started receiving numerous applications for generic product registration from little known companies with no established reputation in the domestic and international pharmaceutical market. Usually these products were produced for domestic consumption only. 

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