GMP News - Counterfeit Medicines


EDQM Database on Counterfeit/ Falsified Medicinal Products

The EDQM has announced the launch of a database on counterfeit/falsified medicinal products. This should encourage collaboration between authorities and OMCL laboratories, and enhance knowledge and awareness of the issue of counterfeit/falsified medicines. More information can be found in this News.



A new Legislation in the USA gives more Power to the FDA in the Fight against Counterfeits

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.



EU's Counterfeits Directive - Current Information of the EU Commission regarding the Implementation

First information has now been released about EU Commission's delegated acts on the Counterfeit Directive. Read more about the recommendations made for the implementation of future safety features.



EFPIA selects Microsoft Cloud Platform for the European Verification System against counterfeit Medicines

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.



EFPIA - What Medicinal Product Manufacturers need to know about the European Verification System EMVS

What provisions does a pharmaceutical company have to make today to meet the future requirements of the EU directive against counterfeit medicines? The EFPIA "guidance for manufacturers" shows what is required and what is necessary so that in future the distribution channels for medicines are safe. Read the details in this news.



Traceability: EDQM is Making Progress Towards the Implementation of eTACT

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.



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.


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