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Transatlantic Regulatory Integration of Drug Approval Process Vital for the Global Pharmaceutical Industry, Notes Frost & Sullivan
Date:5/19/2009

LONDON, May 19 /PRNewswire/ -- Regulatory processes differ across continents, posing challenges to drug launches. There is a pressing need to integrate the regulatory environment of the European Union (EU) and the U.S. Diverse regulations impact drug launches as less price controlled markets witness quicker launches, while it takes longer in regulated markets. The pharmaceutical industry, along with regulatory agencies, has been working closely with The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to develop a standard set of regulatory processes for Europe, the U.S., and Japan.

(Logo: http://www.newscom.com/cgi-bin/prnh/20081117/FSLOGO)

New analysis from Frost & Sullivan (http://www.pharma.frost.com), Drug Approval Process in Europe - An Outlook, provides an insight into the mutual recognition procedure, centralised procedure, price controls, and parallel trading. In this research, Frost & Sullivan's expert analysts thoroughly examine the EU regulatory processes, comparing the EU and the U.S. drug approval processes, price controls and parallel trading, biosimilars approval, and bi-lateral and tri-lateral integration.

"The future of the pharmaceutical industry lies in the globalisation of the drug approval processes," notes Frost & Sullivan Programme Leader Sylvia Miriyam Findlay. "Pan-European integration and transatlantic coordination on the regulatory front is high on the agenda for Europe, Middle East and Africa (EMEA) and the Food & Drug Administration (FDA) in the Unites States."

Several companies are venturing into manufacturing biosimilars, since biologics are on the v
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