What's happening?

Geriatrics represent the most important patient population to consider for patient-centric dosage forms.

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.

The Falsified Medicines Directive (FMD) came into effect on Saturday 9th February 2019, with the aim of enhancing the security of manufacturing and delivering medicines released to the European market. To this end, pharmaceutical manufacturers are now obligated to implement specific measures across packaging lines in order to comply with new data and reporting requirements.

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.