The year 2018 will see the implementation of new regulations in the fight against counterfeiting in the European pharmaceutical industry via the Falsified Medicines Directive (FMD). Since the countdown began, the industry has been speculating on the delegated acts of the Directive that will result in a safer supply chain, exact details of which are due to be announced at the end of 2015.
Falsified and counterfeit medicines are a chronic problem for the pharmaceutical sector, with a third of all shipments in the worst affected parts of the world estimated to contain fake medicines. Highly portable and often extremely valuable, medicines continue to be a favorite with those determined to fake products or subvert the system for illegitimate gain. Faced with this continued global threat, legislatures around the world are responding by tightening the supply chain to stamp out illicit goods.
In the almost 40 years since counterfeiting of pharmaceutical products was recognized as a problem by the World Health Organization (WHO), the industry has waged a constant battle against increasingly sophisticated and organized counterfeiters, with drug packaging serving as one of its foremost defenses.
In recent years the production of, and trade in, falsified medicines – both research based and generic – has grown to become a global illegal business. At the borders of the EU alone over 30 million counterfeit medicines have been seized during the last five years, and the statistics regarding medicines supplied online are equally disturbing: according to the European Alliance for Safe Medicines, 62% of medicines purchased online are fake or substandard.
Recent US and EU serialization mandates have introduced the GS1 DataMatrix barcode symbology into a much wider role in the pharmaceutical supply chain. While linear barcodes have served as identifiers for SKU- and lot-specific information, the more compact GS1 DataMatrix is now being used as the designated carrier for the greater amounts of data needed to authenticate and track each bottle and carton of prescription drug product. As the role of the DataMatrix has expanded, so has the need to read it consistently and reliably throughout the supply chain.
Antibody-drug conjugates (ADCs) have become de rigueur for pharmaceutical oncology drug development pipelines. There are more than 40 ADCs undergoing clinical trials and many more in preclinical development. Get the latest on novel protein modification platform and its application to generate ADCs, including new conjugation chemistries and linkers.
With the increasing complexity of biologics and growing competition, a comprehensive approach involving advanced drug delivery and development technologies, as well as cutting-edge analytical techniques is needed to support development goals. Learn about the strategies to drive biologics and biosimilar development programs and meet aggressive development timelines.
Clinical supply models need to provide for an adequate supply of patient kits that allow for variations in patient recruitment levels and clinical site activity. Traditional, or supply-led models, address this challenge by creating large quantities of finished patient kits upfront in order to create a cushion of static inventory to manage uneven demand. However, this cushion comes at a cost including lingering potential for stock-outs at high recruiting or new clinical sites, 30-200% drug waste and weeks or even months of lead time for packaging.