Keyword: European Medicines Agency (EMA)

News

Roche Offers Compromise in Flu Drug Row

22.11.2012 - Roche has offered an olive branch to scientific critics in a bid to end a bitter row over blockbuster flu drug Tamiflu that has led to calls for a boycott of the Swiss drugmaker's...

News

Roche May Face Fines for Lax Drug-Safety Reporting

23.10.2012 - Europe's drugs regulator has started an infringement procedure against Swiss pharmaceutical group Roche Holding to investigate its alleged failure to report fully tens of thousands...

News

EU Agency Lifts Lid on Drug Data Secrets

15.07.2012 - Europe's medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl...

News

EMA Boosts EU Transparency with Online Publication of Suspected Side Effect Reports

31.05.2012 - The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: www...

Plant Construction & Process Technology

Non-compliance is on the Rise

19.10.2011 - Steady Increase - All who follow industry trends will have noticed an increase in regulatory actions related to non-compliance issues. We can see this in the increased issuance of...

News

Rx-360 Continues to Intensify Work in 2011

19.01.2011 - Looking Ahead - Rx-360 turns two years old this month, and the international supply chain consortium can look back on a host of achievements. The group now boasts over 50...

News

European Medicines Agency Doesn't Expect Number of New Drug Filings to Grow in 2011

22.12.2010 - The European Medicines Agency expects roughly the same number of new drug applications in 2011 as in 2010, suggesting the pharmaceuticals industry has as yet done little to improve...

News

Biosimilar Antibodies: EMA Adopts Guideline

22.11.2010 - European regulators adopted a new guideline on so-called biosimilar antibody drugs on Friday, paving the way for cheaper copies of multi-billion-dollar medicines for cancer and...