Quality Systems

Sean Milmo is a freelance writer based in Essex, UK.

Articles

Member states in the EU are working to implement the newly passed Falsified Medicines Directive.

Report from Europe

Eastern Europe's pharmaceutical leader, Hungary, is working to maintain its number-one status while also pursuing new avenues, especially in biopharmaceuticals.

Report from Hungary

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.

Public-private R&D partnerships are on the rise across Europe, but national goals and academia-industry competition could prevent their success at the European level.

Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients.

Regulators and industry move to require inspections of API manufacturing facilities.

In the Field: Report from Europe

Despite its shrinking domestic economy, Ireland is determined not to let its pharmaceutical industry fade into the shadow of global recession.

Report From: Ireland

As the pharma industry desperately seeks to cut costs and streamline production, a new breed of CMO is growing in Europe. Find out how today's CMO is capitalizing on pharma's plant closures and divestments.

European CMOs profit from others' loss

Although industry is tightening its belt, contract manufacturers across Europe are actually making out quite well by taking on additional projects and new roles.

Report from: Europe

Although the European Union's approval rates of biosimilars for market is increasing slower than expected, its approach may provide an example for other foreign markets.

European Regulatory Watch