What's happening?

Ulf Bremberg, Johan Eriksson-Bajtner, Fredrik Lehmann, Viveca Oltner, Ellen Sölver, and Johan Wennerberg
  Org. Process Res. Dev. 2018, 22, 1360−1364

At FutureLink Munich 2018, a survey regarding serialisation and the EU’s Falsified Medicines Directive (FMD) was conducted. Over 1600 responses were submitted from more than 200 pharmaceutical and healthcare executives, with many indicating that the industry is not as prepared as it should be for the new regulation.

In general, the barriers faced by Recipharm will be the same across the pharma industry, the most difficult of which being financial.

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.