Transatlantic Regulatory Integration Of Drug Approval Process Vital For The Global Pharmaceutical Industry, Notes Frost & Sullivan

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 May 2009 - 3:00 PDT

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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 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.

New analysis from Frost & Sullivan , 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 verge 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."

Drug Approval Process in Europe - An Outlook is part of the Pharmaceuticals & Biotechnology Growth Partnership Service programme, which also includes research in the following markets: European Vaccines Market, European Biosimilars Market, and European Orphan Diseases Market. All research services included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants. Interviews with the press are available.

GIL 2009: Europe

Frost & Sullivan has expanded its flagship Global Congress on Corporate Growth - GIL Global - into several major cities around the world including London. For the first time ever in Europe, Frost & Sullivan will be hosting the Growth, Innovation and Leadership Congress 'GIL 2009: Europe' today and tomorrow, 19-20 May, at the Sofitel St James in London. GIL Global is the industry's only event designed to support senior executives in their efforts to achieve sustainable, top-line growth. To register, obtain a programme agenda, explore sponsorship opportunities, or attend as a member of the media for GIL 2009: Europe, please contact Katja Feick, Corporate Communications Europe, at katja.feick@frost.com. One-on-One interviews with Frost & Sullivan senior growth consultants are also being scheduled. For more information you can also visit http://www.frost.com/gilglobal

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Frost & Sullivan

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