GMP News - Counterfeit Medicines

The US FDA has published a list of 22 Chinese companies who fail to comply with the GMP regulations. All companies manufacture Heparin. Please read more here.

Ilisa Bernstein from the FDA suggests in an official FDA presentation as first-step measure to ensure patient safety through increasing "Supply Chain Integrity" activities. Another important measure are the enhanced resources for the new Office of Drug Security, Integrity, and Recalls. Read more in this News.

In February 2012, the EMA published a  Reflection Paper on "Starting Materials" and "Intermediates" derived from different sources and used for the manufacture of biological medicinal products. The document specifically concerns Heparin, but also plasma and urine derived products. Read more here in the News.

The EDQM eTACT project aims to develop a harmonised, standardised and centralised traceability and mass-serialisation system that can be used by authorities and all stakeholders. Read more.

In a position paper issued in March 2011 the European Pharma Federation (EFPIA) and the Organisation of pharmaceutical wholesalers (GIRP) together with the Pharmaceutical Group of the European Union (PGEU), agreed on 10 important principles that should be taken into account when implementing new proposals, particularly through so-called delegated acts. The objective is to improve patients' safety. Read more about this position paper.

A further step has been made to fight against counterfeit medicine. Twelve countries have paved the way for the implementation of the Medicrime Convention by signing the first international treaty on October 28th. Please read more here.

On 1 April 2011 the FDA and the EMA started a pilot project (see our GMP News from 6 April 2011) for the evaluation of QbD authorisation applications. On 17 June the two authorities informed about the first dossier within the pilot programme which was issued by Pfizer. Read on here.