GMP News - Counterfeit Medicines


Updated on Implementation of the Counterfeit Directive 2011/62 in the EU Countries

All EU countries are obliged to transpose the requirements of the so-called Counterfeit Directive 2011/62EU in their national legislation. Read more here about the implementation.



DataMatrix Code on Pharmaceutical Packaging - Pilot Project starting in January

The securPharm initiative has announced that a nationwide pilot project will be started from January 2013 in Germany to test safety features. Read more here.



FDA identifies 22 Chinese companies out of GMP compliance

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.



Rx-360 releases New Checklists

Rx-360 has released a range of documents which are very useful in daily practice. Read more.



Interesting FDA Presentation on Supply Chain Integrity

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.



Track & Trace: SecurPharm Pilot Project now also considers the GS1 Standard

At a meeting on 30 March 2012, the participants involved in the SecurPharm project agreed on essential technical and organisational details to be implemented in the pilot project. This project will start in the beginning of 2013 in Germany. Read more in the News.



New EMA Reflection Paper on Heparin and further Biological Starting Materials

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.



American Pharmaceutical Association suggests its own Model for Track and Trace

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.



The EDQM eTACT Project for an Anti-Counterfeiting Traceability Service for Medicines

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.



Safety Features & Drug Authentication: Which System will prevail?

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.



Joint Statement of the EFPIA, GIRP and PGEU regarding Falsified Medicines

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.



New Concept Paper of the European Commission on the Use of Safety Features against Falsified Medicinal Products

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.



Twelve Countries sign Medicrime Convention on Counterfeit Medicines

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.



German Initiative 2D Matrix Code SecurPharm started on 31 August!

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.



Pfizer transfers first QbD Dossier within the FDA/EMA Project

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.


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