Standards & Regulation

The EMA says it will review its standards for first-in-human trials

Automated image analysis has been combined with Raman spectroscopy to achieve component-specific size and shape analysis of active ingredients, supporting and accelerating the commercialization of both innovator and generic pharmaceutical products.

Astronomers Chris Leigh and Mike Merrifield debate how a potential Brexit might impact UK science

Angus Dalgleish tells us about his experience with EU regulation – and why he thinks Britain should leave the EU.

As politicians and the public argue over the minor point of the UK leaving Europe, we ask a more important question: what will a “Brexit” mean for the global pharmaceutical industry?

The term ‘packaging’ may not immediately evoke excitement – but without innovation in the field, some therapies wouldn’t even reach market. In other words, don’t judge a box by its cover because there’s more to packaging than meets the eye… and even more lies on the horizon.

A US coalition seeks lower prices for US prescription drugs, but could their proposals undermine the competitive market?

Innovation is increasingly coming from small biotechs, but such companies rely on external funding to develop the compounds. A solid regulatory strategy is essential to convince investors to fund the further development.

Sitting Down With... Christian Schneider, Director of the National Institute for Biological Standards and Control (NIBSC), UK.

The use and misuse of antibiotics is a major driver behind the drug-resistance problem, but large environmental discharges of antibiotics from pharma manufacturing can also contribute. It’s time for companies to live up to their ethical responsibilities.