GMP News - Counterfeit Medicines


The 4th European GMP Conference a great Success - Read more about major GMP Developments

From May 20-21, 2011 the 4th European GMP Conference was held in Heidelberg. The Conference attracted delegates from 25 different countries. The conference was booked up! Read more about the highlights.



New Pharma Directive on Counterfeit Medicine adopted by EU Parliament

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.



Compliance Policy Guide: RFID Studies and Pilot Programs for Drugs

FDA is extending the expiration date of compliance policy guide (CPG) Sec. 400.210 entitled ‘‘Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs’’ to December 31, 2012. Read more here.



Rx-360 receives Approval from FTC and exhibits at CPhI Tradeshow

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.



FDA Proposes to Publish More Information about Inspection Planning and Outcomes

The FDA has established an FDA Transparency Task Force. Among many other topics inspection-relevant information may also be published in much more detail in the future. Click here to read more.



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.


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