spacer
home > ict > autumn 2018 > the imminent exit
PUBLICATIONS
International Clinical Trials

The Imminent Exit

Brexit: it seems to dominate the news (in the UK, at least) and the reporting is getting ever more frantic and misleading. It seems to me that far too many people have been swept into the Brexit system of fear that appears to be the basis of all public policy these days. Edmund Burke said, “no passion so effectually robs the mind of all its powers of acting and reasoning as fear.” It may well be that this is the case for all the participants in the Brexit debate, be they pro, anti, second vote, or of any other opinion.

In the pharmaceutical arena, it seems that the membership, or otherwise, of the EMA and adherence to its regulation is the one most desired by the UK government and by the industry. Currently, most novel drug applications go through the centralised procedure, which allows pharma companies to apply for market access across the EU through a single application with the EMA. Although the UK has indicated it would like to continue using this procedure, in March 2018, the EU rejected any possibility of the UK remaining a member of the EMA post Brexit, and guidelines for Brexit published by the EMA state that they are working on the basis of the UK not having access to the centralised procedure after 30 March 2019. This makes it unlikely that the UK will be part of the centralised procedure in the future. However, although we read recently that 95% of the deal is done, there is no clarity on the possibility of the UK remaining part of the EU’s EMA.

If the UK is outside the EMA scheme, an alternative scenario to retaining access to some European drug regulatory pathways would be for the UK to operate entirely outside the EU’s drug regulatory process. This could result in slower access to novel and generic drugs by several years, since drug companies will likely prioritise application for marketing authorisation in the significantly larger US and EU markets, before turning to the UK. However, I ask, if the UK is still of the belief that the EMA is a responsible and scientifically rigorous organisation (many UK staff would presumably still be retained by the EMA), then what is to prevent the UK automatically adopting a recognition procedure identical to the one that is already in place? Only fear of the unknown, perhaps?

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Print this page
Send to a friend
Privacy statement
News and Press Releases

Protagen Protein Services (PPS) reaches new level in characterizing HCP protein impurities

In response to current regulatory guidance a Mass Spectrometry (MS) based Host Cell Protein (HCP) detection approach with faster, more accurate and wider-ranging detection is essential. In order to meet the newly prevailing demands Protagen Protein Services (PPS) recently invested in more far-reaching MS capabilities: The new high-performing mass spectrometer ThermoFisher Q Exactive™ HF-X started operational service last month and brings PPS to the next level of reproducible, accurate and sensitive analyses of majorly complex samples for different aspects of translational research and biopharma applications.
More info >>

White Papers

Keeping Abreast of the Competitive Environment in Clinical Development

Thomson Reuters

Strategic management of a therapy area requires hard decisions to be made about which programs to invest in and which to let go. Understanding the rapidly changing competitive environment for your drug candidates is a key input into these decisions. It is easy to lose track of the broader picture when a clinical program is in progress and get blindsided by external events.
More info >>

 
Industry Events

SMi Presents the 11th Adaptive Designs in Clinical Trials Conference 2019

1-2 April 2019, Holiday Inn Kensington Forum, London

SMi Group are proud to announce the 11th annual Adaptive Designs in Clinical Trials conference and exhibition will return to London from the 1st – 2nd April 2019. With the growing popularity in use and acceptance of adaptive designs in clinical trials - demonstrated most recently with the new FDA draft guidance on adaptive designs – there is a pressing need for a forum which explores this increasingly normalized medical methodology.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement