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Wait For Benefits Of EudraVigilance Pilot Before Expanding To More EU Products, Says Pharma

 
• By Vibha Sharma

Drug companies say that any decision on taking the EudraVigilance monitoring requirements into the next phase should only be made when there is clear evidence that it has improved patient safety.

Papers
EudraVigilance Pilot Has Significantly Increased Workload For Companies • Source: Shutterstock

The pharmaceutical industry says it is "very relieved" that the ongoing EU signal detection pilot involving the revamped EudraVigilance database – which was due to end after one year of operation on Feb. 22, 2019 – has been extended until further notice, but it is making a case to ensure it does not move into the next implementation phase until there are meaningful data to demonstrate its benefits.

Although the pilot has been extended for now, the industry is concerned how things will play out beyond that

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More from Europe

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

More from Geography

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.