GMP News - Counterfeit Medicines


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.



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.



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.


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