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 v
'/>"/>

SOURCE Frost & Sullivan
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

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:7/9/2014)... (PHILADELPHIA) Researchers at the Perelman School of Medicine ... Roswell Park Cancer Institute have received an $8 million ... the effects of photodynamic light therapy (PDT) in patients ... cancer that most often manifests itself in the lining ... exposure to asbestos. The grant will fund a clinical ...
(Date:7/9/2014)... network of signals active in almost all types of ... overdrive, and may help fuel a tumour,s uncontrolled growth, ... Cancer Research, London, identified a molecular trigger responsible for ... the cellular factory that makes the building blocks cancer ... the TOR signalling pathway, called SREBP, controls the flow ...
(Date:7/9/2014)... cancer, researchers have uncovered mutations in a cell-signaling pathway ... knowledge may expand treatments for patients because drugs targeting ... are in clinical trials. , Reporting July 9 in ... (TCGA), including researchers at Washington University School of Medicine ... studied tumors from 230 patients with lung adenocarcinoma. , ...
(Date:7/9/2014)... Chase Cancer Center paint a relatively optimistic picture of ... that have spread to the chest wall or skin, ... the skin, regardless of size and whether they have ... and called "locally advanced" tumors, suggesting that they ... poor survival. Locally advanced breast cancers of this and ...
(Date:7/9/2014)... used in policing injection drug users in Russia ... , A study, conducted by researchers from ... in collaboration with St. Petersburg Pavlov State University, ... on the health outcomes of a cohort of ... , Those who were arrested by police were ...
Breaking Medicine News(10 mins):Health News:Penn mesothelioma program receives $8 million NCI grant 2Health News:Signal may send cancer's cellular factories into overdrive 2Health News:Lung cancer study hints at new treatments 2Health News:Fox Chase researchers recommend updating the staging criteria for breast cancer diagnoses 2Health News:Fox Chase researchers recommend updating the staging criteria for breast cancer diagnoses 3Health News:BU researchers relate arrests with HIV risk environment 2
... TO LIFE , , CHICAGO, ... Maria Siemionow, MD, who performed this country,s first face transplant ... Facial transplantation plastic surgery offers great hope for those who ... "The nation,s first face transplant is another great ...
... A new U.S. study has found that being circumcised ... African American men known to have been exposed to ... clinical trials in Africa, where interventional use of adult ... in heterosexual men. The findings of the new study, ...
... , , WASHINGTON, Dec. 17 ... released A Call for Action: Enabling Healthcare Reform Using ... recommendations for the Obama Administration and 111th Congress to harness ... , , "President-elect Obama and ...
... bacteria make their home in the vertebrate gut. Though ... host, othersthe pathogensare unwelcome visitors, causing disease. , ... bacterium. It has evolved sophisticated means of growth, replication, ... body, where it is responsible for most cases of ...
... Bulletin Board: VHGI) the owners of Veriscrip(TM), the,nation,s only ... appointed Anthony Bocchichio to its Advisory Board. , ... 37 years of experience in Federal drug law,enforcement, 25 ... He served,as both Assistant Special Agent in Charge and ...
... record number of course dates for its STARCenter in 2009. ... 22 class sessions focused on pharmacy best practice in relation ... handling. , , ENGLEWOOD, Colo., ... dates for training at its STAR (Skills Training, Academics and ...
Cached Medicine News:Health News:Plastic Surgery Experts Available to Comment on Face Transplant Surgery 2Health News:Circumcision reduces the risk of HIV infection in heterosexual US men 2Health News:HIMSS Releases Health IT Blueprint for Obama Administration and Congress 2Health News:HIMSS Releases Health IT Blueprint for Obama Administration and Congress 3Health News:HIMSS Releases Health IT Blueprint for Obama Administration and Congress 4Health News:Gut instinct: Salmonella bacteria's molecular tactics to cause illness 2Health News:Gut instinct: Salmonella bacteria's molecular tactics to cause illness 3Health News:Gut instinct: Salmonella bacteria's molecular tactics to cause illness 4Health News:VirtualHealth Technologies, Inc. Appoints Former DEA Assistant Administrator to its Advisory Board 2Health News:Baxa Announces 2009 Course Dates for Its STAR Center(R) Training Facility 2Health News:Baxa Announces 2009 Course Dates for Its STAR Center(R) Training Facility 3Health News:Baxa Announces 2009 Course Dates for Its STAR Center(R) Training Facility 4
(Date:1/14/2014)... 2014   NuAire , a manufacturer of ergonomically designed laboratory ... Koki of Japan to sell and ... . NuAire will utilize its network of sales professionals throughout ... to offer assistance in application use, product benefits and ...
(Date:1/14/2014)... VALHALLA, N.Y. , Jan. 14, 2014   Oligomerix, Inc. ... disease modifying therapeutics for Alzheimer,s disease (AD) and related ... headquarters to Valhalla, NY as ... additional laboratory space at New York Medical College. ...
(Date:1/14/2014)...   Evidera , a leading provider of evidence-based solutions ... Drug Evaluation and Research (CDER), U.S. Food and Drug ... for a patient-reported outcome (PRO) measure in drug development: ... [EXACT] for Measurement of Symptoms of Acute Bacterial Exacerbation ...
Breaking Medicine Technology:NuAire announces sales and service of Hitachi Koki centrifuges in North America 2Oligomerix Relocates Corporate Headquarters and Secures Additional Laboratory Space from New York Medical College 2Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations 2Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations 3Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations 4
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: