GMP News - Counterfeit Medicines


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.



FDA creates "Super Office" for better GMP Monitoring and Fight against Counterfeit Medicines

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.



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.


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