What's happening?

Progressing a drug from early phase development to first in human (FIH) trials often presents a complex challenge in which there are many potential pitfalls. In fact, a poor safety profile leads to almost two thirds of projects being cancelled in their early stages.

When drug products are transferred from the UK to the EU market, they will still need to comply with FMD requirements.

There are many reasons why oral solid dosage (OSD) forms remain the most popular, including their cost effectiveness, patient-friendly nature and ability to extend product lifecycles by implementing extended, controlled and rapid release formulations.

Orally inhaled drug products offer many therapeutic advantages over other dosage forms, the primary advantage being a direct delivery to the central nervous system. As such, drug developers can produce delivery strategies that reduce the chances of patients experiencing adverse effects.

Källsten, M., Pijnappel, M., Hartmann, R. , Lehmann, F., Kovac, L., Bergström Lind, S.  and Bergquist, J Analytical and Bioanalytical Chemistry (2019)

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.

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.