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

erge of patent expiry. This has led to the formation of new regulatory pathways for biosimilar approvals in the EU. The EU has pioneered the creation of a regulatory pathway for biosimilars in Europe.

However, the gap between European regulatory authorities and national pricing authorities needs to be bridged. Although centralised procedures authorise the sale of drugs in all member states, pharmaceutical companies still have to file for price or reimbursement approvals. Some countries have distinct methods of drug price approvals and their processes are not always transparent, making it difficult for drug manufacturers to do business in Europe.

"The unfavourable regulatory environment, varying price controls across member states, and parallel trading hinder the growth of the pharmaceutical industry in Europe," explains Findlay. "Due to the varied price regulations across EU, research intensive firms undertake R&D activities in less price controlled markets."

EU wide synchronisation will make the approval process faster, reducing delays in drug launches. Transatlantic co-ordination will also aid in streamlining regulatory costs. Transatlantic regulatory convergence will have immense benefits such as faster technology transfer, regulating approval of unsafe drugs, and patent law harmonisation.

"EMEA should encourage frequent dialogues with patient and industry representatives to ensure a transparent approval process," notes Findlay. "Such interaction will also aid in redefining the clinical trial design and streamline the drug approval process."

If you are interested in a virtual brochure, which provides a brief synopsis of the research and a table of contents, then send an e-mail to Katja Feick, Corporate Communications, at katja.feick@frost.com'/>"/>

SOURCE Frost & Sullivan
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