What's happening?

Following the EMA’s most recent survey, which concerned pharmaceutical companies’ preparedness for Brexit, it became apparent that very little guidance had been given to businesses on how best to prepare for the change.

The introduction of more thorough quality control regulations is changing how companies test drug stability, with more and more turning to outsourcing for efficiency. Stability studies are among the most important in the drug production process, as they influence planning production and expiry dates.

In response to the UK’s decision to withdraw from the European Union, the European Medicines Agency (EMA) will relocate from London, UK to Amsterdam, the Netherlands in less than six months’ time.

The 1st July marks six months until the European Medicines Agency (EMA) relocates from London, UK to Amsterdam, the Netherlands, in response to the UK’s decision to withdraw from the European Union.

The opioid addiction crisis in the US is a pressing problem in healthcare; one many believe may also affect Europe in years to come. The US Centre for Disease Control and Prevention estimates that, from 1999 to 2016, over 200,000 deaths have occurred due to prescription opioid abuse in America.

As global demand for high quality pharmaceuticals increases, as does demand for contract providers that offer manufacturing that is ‘full service’.

The Drug Supply Chain Security Act (DSCSA) will ensure the complete traceability of prescription drugs at all levels of the supply chain in order to combat counterfeits in the industry, coming into full effect in just six months’ time. 

The Drug Supply Chain Security Act (DSCSA) comes into full effect in only six months’ time, having been originally signed by President Obama in 2013.

Careful planning is required when attempting to move a promising drug candidate to first-in-human (FIH) trials. Both safety and the cost effectiveness of the new drug must be taken into account.

The European Falsified Medicines Directive (EU FMD) comes into effect in February 2019, which only leaves a couple of months for pharmaceutical companies and contract manufacturing organisations (CMOs) to achieve compliance.