Navigation Links
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 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."

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, with your full name, company name, title, telephone number, company e-mail address, company website, city, state and country. Upon receipt of the above information, a brochure will be sent to you by e-mail.

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

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best in class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best practice models to drive the generation, evaluation and implementation of powerful growth strategies. Frost & Sullivan leverages over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from 35 offices on six continents. To join our Growth Partnership, please visit http://www.frost.com.

Drug Approval Process in Europe - An Outlook

M2DB

    Contact:
    Katja Feick
    Corporate Communications - Europe
    P: +49 (0) 69 7703343
    E: katja.feick@frost.com
   http://www.frost.com/


'/>"/>
SOURCE Frost & Sullivan
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Transatlantic alliance supports breast cancer research
2. British Council and Los Angeles Area Universities Partner to Host Transatlantic Dialogues
3. Beckman Coulter Pending Acquisition of Olympus Diagnostics Systems Passes Milestone with U.S. Regulatory Approval
4. Blue Mountain Quality Resources Announces that Cepheid has Selected Blue Mountain Regulatory Asset Manager
5. Bobbi Drais Promoted to Vice President, Regulatory Affairs for HEALTHPOINT, Ltd.
6. Higher Outlays and Improved Regulatory Enforcement Create Opportunities in the Kenyan Healthcare Industry, Reveals Frost & Sullivan
7. Solta Medical Receives Regulatory Approval to Market Thermage Systems in China
8. HIPAApedia.com Goes Live - The First Dedicated Educational Community Wiki Aimed at Healthcare Information Professionals Interested in HIPAA Regulatory Issues and Solutions.
9. ATS Medical Announces Regulatory Approval of the ATS Open Pivot AP360 Mechanical Heart Valve in Japan
10. Lionbridge Announces Partnership with Open Text to Streamline Regulatory Compliance Solutions for Pharmaceutical Companies
11. Xoft Receives Health Canada Regulatory Approval for the Axxent(R) Electronic Brachytherapy System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... ... (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, along ... updates for the primary prevention of cardiovascular diseases during the 15th Annual ...
(Date:10/13/2017)... ... 13, 2017 , ... Many families have long-term insurance that covers care for ... a waiver for care if the client has a cognitive impairment diagnosis. , ... care, is often waived, so the benefits from their insurance start immediately,” said Mechell ...
(Date:10/13/2017)... NJ (PRWEB) , ... October 13, 2017 , ... Global ... at scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global ... physical activity. The fun run is geared towards children of all ages; it ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in agile ... a contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise ... use of Agile methodologies in a consistent and high value manner across CMS ...
(Date:10/12/2017)... ... 2017 , ... First Healthcare Compliance (FHC), an industry leader ... range of technology and learning solutions at the 68th Annual American Healthcare Association ... held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, Nevada. ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)...   Divoti USA will engrave and process ... of the latest FDA requirements, which stipulates new criteria regarding medical ... need of Medical ID jewelry such as Medical ID Bracelets, can ... in terms of the new FDA requirements . ... Divoti offers this dark mark fiber laser ...
(Date:10/11/2017)... 11, 2017  Caris Life Sciences ® , a ... promise of precision medicine, today announced that St. Jude ... Oncology Alliance™ (POA) as its 17 th member. ... Jude Crosson Cancer Institute will help develop standards of ... tumor profiling, making cancer treatment more precise and effective. ...
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
Breaking Medicine Technology: