Standards & Regulation

The latest edition of the European Pharmacopoeia was published in July 2016 and some large changes are afoot.

Sitting Down With… Susanne Keitel, Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe in Strasbourg, France.

Today’s cleanrooms may meet current quality standards, but what about the future?

The technology behind cleanrooms is well over 50 years old. Is it time for a makeover?

Researchers call for more oversight as some pharma companies cozy up to hemophilia patients.

The world’s most populous state is set for big things in patented (bio) pharmaceutical development.

We should look to Warning Letters – and the subsequent solutions – to benefit from the blunders of others.

Packaging components can leach into drug products and become foreign impurities. Guidelines exist for the testing of drug products for elemental impurities, but how are these applied to elemental impurities derived from drug product packaging?

Will future drugs in Europe be priced based on therapeutic outcomes?

How difficult is it to develop a new drug? Statistics have the answer