European Regulatory Watch

Labeling of Biosimilars

February 02, 2015

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Great Expectations from New European Commission

January 02, 2015

The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.

Tackling Drug Shortages

November 02, 2014

Resolving the problem will require more communication between the industry and regulatory bodies.

PTSM: Pharmaceutical Technology Sourcing and Management

WHO Promotes International Collaboration for Generic Drug Approvals

November 01, 2014

The European Union takes the lead in a global pilot project on the marketing approval of generic medicines, highlighting the challenges of achieving consensus among different nations.

No Change to Approved Indication for Ariad's Iclusig

October 10, 2014

Iclusig?s original indication will remain unchanged after a thorough examination of its safety information by EMA.

Harmonizing Marketing Approval of Generic Drugs in Europe

October 02, 2014

Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.

Extending the Scope of Pharmacovigilance Comes at a Price

September 02, 2014

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Pharmaceutical Technology Europe