GMP News - Counterfeit Medicines

The American GPhA (Generic Pharmaceutical Association) has elaborated a proposal - in collaboration with further partners from the pharmaceutical supply chain - to meet FDA's requirements and achieve better patients' safety. Read more about the new RxTEC labels for serialisation.

In a new position paper issued in January 2012, the European Pharma Federation (EFPIA), the Organisation of pharmaceutical manufacturers (GIRP), the European licensed parallel distribution industry (EAEPC) together with the Pharmaceutical Group of the European Union (PGEU) have contested the EDQM's eTACT system for drugs traceability. Read more about the alternative systems.

The concept paper of the European Commission on safety features for medicinal products presents many questions to the stakeholders about the practical implementation. The deadline for comments is 27 April 2012. Read more here.

On 31 August 2011, the initiative SecurPharm - developed by the organisations BAH, BPI, VFA, Pro Generika, PHARGO, and ABDA - started. 270 specialists and managers from the pharmaceutical industry met at the Jahrhunderthalle in Frankfort. Read more here.

With the new "Super Office", the US FDA restructured the Office of Compliance - the most important Office in the field of GMP. Read more here.

Yesterday the amendments on the Directive EC 2001/83/EC to combat counterfeit medicines (The Pharma Package) have been discussed in the European Parliament. Today, the EU Parliament adopted the amendments with an overwheling majority of votes.

The proposed amendments, which will have to be transferred into national law within two years include

introduction of safety features (serial numbers and/or tamper-evident seals) more stringent rules for importation of APIs better controls of the supply chain (traders and wholesalers) Rules for the internet sale of medicines Harmonisation of GMP inspections

For further information please see the complete news.

The Rx-360 Consortium held a meeting at Merck KGaA in Darmstadt. Ms. Joanne Lewers, Partner at Drinker Biddle & Reath, the consortium's Legal Counsel and Secretary, announced that the U.S. Federal Trade Commission (FTC) has provided a positive advisory opinion pertaining to the organization's shared auditing programs. You will find more here.