GMP News - Counterfeit Medicines


FDA Inspections in China - Consequences from the Heparin Case

The USA is still systematically evaluating the experience in the Heparin case. More precisely this means that the former FDA inspections at Heparin manufacturers in China were analysed. Read more here.



EFPIA Publishes Results of the Track & Trace Project

In April, the EFPIA published the report about the pilot project on the tracing and verification of medicinal products in Sweden. Read more.



FDA Finalises Guidance on the Standardisation of the Numerical Identification for Medicinal Products

In March, the FDA published the final version of its guidance on the standardised numerical identification for prescription medicinal products. Read more.



Tracking & Tracing: EU decides on Amendments to Guidelines

The Committee on Internal Market and Consumer Protection of the European Parliament held a vote in March on numerous amendments to the draft directive from the EU Commission on the combating of counterfeit medicines. Read more.



Germany's Preparations for the Traceability of Medicines

Germany is now starting a pilot project for the introduction of an identification/authentification system for the traceability of medicines. Read more.



Counterfeit Medicines: EFPIA Position Paper on the European Commission's Draft

In a position paper of October 2010, the EFPIA comments on the draft by the European Commission for fighting counterfeit medicines. The EFPIA calls for measures that go beyond those laid down in the Commission's draft. Details on the EFPIA position paper can be found here.



Interesting Pilot Project for safe Trade Routes introduced

The Secure Trace Consortium has introduced an interesting case study for a pilot project on presenting a safe supply chain. Additional details can be read here.



MHRA Consultation Procedure for Strengthening Secure Supply Chains

On 17 December 2009, the MHRA issued a public consultation procedure on the measures for strengthening the supply chains for medicinal products and for reducing the risks of counterfeit medicines. More can be found here.



Which Role Does the Rx-360 Consortium Play in the Fight against Counterfeit Medicines?

The RX-360 Consortium is an industry initiative aiming at making the pharmaceutical supply chain more secure, especially with its efforts to combat counterfeit medicines. Rx-360 is meant to set internationally harmonised standards. More information on RX-360's activities and objectives can be read here.



Current FDA Procedures for Counterfeit Medicines

The FDA is taking part in an international campaign week in opposition to counterfeit medicines on the Internet. This campaign week has been coordinated by an international working group from WHO to combat counterfeit medicines (IMPACT). You can read more here.



FDA announces new Programme for a more efficient Inspection of Imports

During a speech on February 4, 2010, Dr. Margaret Hamburg, commissioner of the FDA, introduced a new programme with which the FDA will be able to inspect products for import more effectively and efficiently. From Dr. Hamburg's point of view, measures for the safeguarding of the supply chain ("global supply chain safety") have top priority. You can read more of this speech here.



Current Status of the Counterfeit Directive in the EU Parliament

The proposed directive about counterfeit medicines contains a number of provisions which will have a major impact for the GMP environment. In December 2009 the EU parliament published a draft report. Read more here.



Discussion about Safety Features/2D Datamatrix Code Continues

In December 2008, the European Commission presented proposals for ensuring safe medicinal products and combating counterfeit medicinal products. In early December 2009, the Committee on the Environment, Public Health and Food Safety conducted a meeting  - where some of the details were subject to controversial discussions. Get the details here.


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