GMP News - Counterfeit Medicines

Just recently we reported about the counterfeited HIV drug Viread (Tenofovir) from Gilead and how the counterfeited Viread packs had penetrated into the legal supply chain. At that time a parallel importer had detected the deviations and could therefore stop the further distribution. Now, promptly another two cases came up. Read more about the counterfeiting of the drug Humira.

Currently, drug supply chain traceability and verification systems are implemented in the EU and the US. Unfortunately the approaches are slightly different. Read more.

In a publication in the Pharmacopeial Forum, the USP describes the future USP chapters planned for Good Distribution Practices (GDP). The new Chapter <1083.4> focuses on the supply chain integrity and security. More information can be found here in the News.

The revision of the General Chapters on Good Distribution Practices (GDP) has highlighted in a new USP chapter the safety and integrity of the supply chains for starting materials and medicinal products. More information can be found in the News.

At the end of November 2013, President Obama signed the "Drug Quality and Security" Act in the USA. With this Act, the FDA gets the legal obligation to implement a Track & Trace system in the USA. In February, the FDA published the first timetable for the implementation. Read more in the News.

After a selection process over 15 months and out of 20 vendors the EFPIA and the European Medicines Verification System (EMVS) has chosen the software company Solidsoft with the cloud-based Windows Azure from Microsoft. You will find everything else in this news.

Traceability is on everyone's lips. Directive 2011/62/EU - the so-called Counterfeit Directive - calls for the introduction of so-called safety features to enable authenticity verification and the identification of individual packages. Read more here about the latest EDQM activities.