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:4/29/2016)... ... April 29, 2016 , ... Our bodies are bombarded ... to confront and deal with these stressors is to adopt a more healthful diet, ... for you. Risa Groux, a certified Holistic Nutritionist and the creator of the Newport ...
(Date:4/29/2016)... ... April 29, 2016 , ... The American workforce is ... even security. Most importantly, employees are the single most important asset in creating ... so unhappy? , Just under half of American workers are emotionally checked out ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... ... student loans more flexibility in repaying their loans, more information about their loan ... time when total outstanding student loan debt, including federal and private loans, has ...
(Date:4/29/2016)... ... April 29, 2016 , ... Coast Dental Fort Stewart ... at its new location in the Exchange Furniture Mall at 112 Vilseck Road in ... 50-inch Samsung Smart TV. Plus attendees will have the opportunity to meet general dentists ...
(Date:4/29/2016)... ... April 29, 2016 , ... Spine Team Texas, a comprehensive spine physician group ... of their physicians has been invited to be a featured speaker at the Texas ... conference on April 30, 2016. , Dr. R. Scott McPherson, a physical medicine ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... Calif. , April 28, 2016  Marking ... widely accessible breast and ovarian cancer risk test, ... panel analyzing 30 genes that highly impact the ... women. Available today, the Color Test analyzes hereditary ... prostate, stomach, and uterine cancers. The Color Test ...
(Date:4/28/2016)... Dr. Vivek Ahuja , George ... phen Schmidt Join the Growing Organization ... for life sciences, today announced key new leaders have joined the ... a growing business.  This will bolster the company,s safety business unit ... ArisGlobal in the position of Vice President - Safety. George has ...
(Date:4/28/2016)... 2016 New market research ... a report that provides an overview of the ... by identifying new targets and MOAs to produce ... discussed in this H1 2016 Osteoarthritis Pipeline report ... Inc., Abiogen Pharma S.p.A., Ablynx NV, Achelios Therapeutics, ...
Breaking Medicine Technology: