What's happening?

The United Kingdom (UK) will leave the European Union (EU) on 29th March 2019. The steps and measures pharmaceutical firms take at this stage will be critical to post-Brexit preparedness, failure to take action could ultimately impact the supply of medicines and patient safety.

The uncertainties surrounding Brexit and the impact it will have on the new EU FMD regulation and wider pharmaceutical industry are growing as the UK’s deadline for leaving the EU draws closer. The UK will have to legally comply with the EU FMD until the 29th March, however insight into what will happen after this date remains limited.

Companies striving to become compliant with the FMD must consider a wide range of factors. From selecting the right hardware and software, to training staff and ensuring that their packing lines will not be disrupted, there is a lot to put in place.

It is now unlikely that all companies will achieve compliance on time without halting production.

Drug products that can be administered through inhalation offer many benefits. While other dosage forms, such as oral solids, are currently more common, inhaled formulations offer direct access to the central nervous system, bypassing the digestive system and liver.

The service sector’s increased growth can be attributed mainly to the fast pace of advancements in research.

The United States of America is facing a hugely concerning opioid addiction epidemic, causing roughly 46 deaths per day according to the US Centres for Disease Control.

Formulating a new candidate drug for first-in-human (FIH) trials must be considered carefully, as the decisions made can directly affect its chances of not only progressing to the next phase, but to achieving regulatory approval.

Pharma companies hoping to achieve regulatory approval for their candidate drug must be able to show efficacy and demonstrate safety for use in a Phase III trial. However, the journey to late stage trials begins with the complex path from formulation development to first in human (FIH) trials.

Moving forward there are tough decisions to be made in terms of site rationalisation. Industry consolidation is inevitable.

There are only a few months left before the introduction of the European Falsified Medicines Directive (EU FMD). Once these regulations are in place, unique codes on pharmaceutical packaging should increase supply chain transparency and make the infiltration of counterfeit medicines more difficult.