« Return to News | Ethics/Regulatory

EMA investigates Roche's alleged non-compliance with pharmacovigilance obligations

Wednesday, October 24, 2012 09:46 AM

The European Medicines Agency (EMA) has initiated an infringement procedure against Roche Registration, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicines.

The infringement procedure follows a pharmacovigilance inspection carried out in 2012 by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), which identified serious shortcomings of Roche's pharmacovigilance processes. The start of this procedure means that the Agency will further investigate the allegations against Roche within the legal framework of Regulation (EC) No 658/2007. It does not prejudge the outcome of the investigation.

The Agency will report the outcome of its investigation to the European Commission who may impose fines or periodic penalty payments under the regulation mentioned above if it finds that Roche has committed an infringement of its obligations.

The Agency has informed Roche, the European Commission and the Member States' national competent authorities that it has started an infringement procedure in this case. The Agency continues to assess the overall public health impact of the inspection.

The legal base for the Agency's opening of formal proceedings is Article 5 of Commission Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorizations granted under Regulation (EC) No 726/2004, the “penalties regulation.”

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.