What's happening?

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.

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.

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.

Drug stability testing is one of the most important parts of the drug production process. These tests aim to determine the performance of a drug under different conditions, such as humidity, sunlight and temperature, and therefore help to decide safe expiry dates.

As the industry continues its preparations for the European Falsified Medicines Directive (FMD), Recipharm has reached another important milestone in its journey to serialisation compliance.

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.