EAASM News

In this section you can read all the latest news about counterfeit and substandard medicines from around Europe and the world.

Science and technology have never moved as fast as now. With personalised medicines and the advent of gene therapy the standard rule book is clearly coming under pressure. And it would appear that the same is true for the technology behind nanomedicines.

Nanomedicines are medicinal products that have a size in the nanoscale range. They have unique properties which allow them to distribute in the body in a way that were previously impossible. This is one of the reasons why nanomedicines have been gaining increasing attention in academia and research, as they have the potential to open up new and improved therapeutic opportunities.

Resources needed to implement the Falsified Medicines Directive in hospitals across the EU and the EEA would cost more than 86 million euros, according to estimates.

The recent report (March 2019) of the European Alliance for Access to Safe Medicines (EAASM) highlights the significant added value that the final patient safety elements of the Falsified Medicines Directive will bring. The Directive requires that every single prescription pack is serialized and has a unique identifier in the form of a barcode and a tamper evident seal. Each pack will need to be verified and decommissioned before it can be dispensed thus confirming the pack is genuine and not falsified.

Nanomedicines are an emerging product class in the health sector which has been gaining increasing attention in academia and research over the past twenty years. It has the potential to provide personalised, yet more affordable, healthcare while at the same time offering better quality of life for the sick and injured, opening up numerous potential pathways to improving medical diagnosis and therapy. However, there is a need to establish robust regulation that is fit for purpose, such as the creation of harmonised definitions across Europe and development of protocols for their characterization, evaluation and pharmacovigilance oversight once an NCE is marketed.

The manufacture and distribution of falsified medicines has become an enormous, serious public health risk with an untold cost to lives.

On 9 February 2019, almost 7 years after its adoption, the final elements of the Falsified Medicines Directive (FMD) came into force introducing the end-to-end verification and safety features on prescription medicines across all Member States, representing a major advance to in patient safety due to the enhanced security of medicines in the supply chain.

The manufacture and distribution of falsified medicines is a growing public health risk with an untold cost to lives. The implementation on February 9th 2019 of the safety features of the Falsified Medicines Directive (FMD) will be a major advance and will greatly help to protect patients from falsified medicines.