Features

• EFPIA seeks vendors for EU medicine verification system

  EFPIA has laid out its vision of how the system of safety features enshrined in the EU Falsified Medicines Directive might work in a call-for-tender document.

• Argentina extends medicine traceability initiative

  Argentina has announced a major extension to its medicines traceability project, boosting the number of drugs covered by the initiative from 350 to around 2,300.

• Stakeholders push lot-level traceability model at committee hearing

  Pharma industry groups and other stakeholders in the USA are bidding for inclusion of a supply chain security model in the latest PDUFA package which stops short of a full, item-level pedigree for medicines but would allow lot-level traceability.

• EDQM showcases eTACT traceability system

  The European Directorate for the Quality of Medicines (EDQM) has confirmed its intention to continue the development of its eTACT drug traceability system.

• USP publishes draft general chapter on supply chain integrity

  USP has published its proposed general chapter on good distribution practices to ensure pharmaceutical supply chain integrity and is seeking comments.

• EC seeks comment on unique medicine identifiers

  The European Commission has published a concept paper on the unique identifier for medicines, outlined in the EU falsified medicines directive and due to be fleshed out via the delegated acts process.

• WHO working group drafts resolution on SSFFC medicines

  Last week's meeting of a WHO working group on low quality and illegal drugs ended with a draft resolution for debate at the next World Health Assembly.

• FDA finalises guidance for on-dose anti-counterfeit technologies

  The US FDA has published its final guidance on the use of on-dose anti-counterfeiting technologies - referred to as physicochemical identifiers or PCIDs - for use in solid oral dosage forms such as tablets and capsules.

• Pangea IV nets illegal medicines worth around $6.3m

  The latest Interpol-backed offensive against illegal medicines has led to 55 arrests and seizures of 2.4m potentially harmful drugs worth around $6.3m.

• FDA report models counterfeiting and diversion patterns in US

  A new report form the US Food and Drug Administration (FDA) has used historical cases of medicine counterfeiting and diversion to gain a better understanding of the methods used by criminals and help prevent incidents in future.

• German traceability pilot for medicines is announced

  A track-and-trace pilot for medicines has been announced in Germany, bringing together the drug industry, wholesalers and pharmacists in improving the security of the pharma supply chain.

• Apple tapped Pfizer expertise to tackle Chinese fakes

  A leaked cable detailing Apple's problems with counterfeiting in China provides fascinating insights into the strategies employed by Pfizer as it tackled the trade in counterfeit Viagra.

• FDA plans to withdraw some pedigree elements of PDMA

  The FDA has said it plans to withdraw a rule which requires secondary wholesalers to include a drug's pedigree back to the manufacturer.

• EU updates GDP in line with falsified medicines directive

  The EU has published a new draft guideline on Good Distribution Practice for drugs, which brings it into step with the Directive on Falsified Medicines.

• 'End of the beginning' for EU Falsified Medicines Directive

  Now that the dust has settled on the approval of the falsified medicines directive attention is turning to the tricky process of implementation.

• Bayer speaks out on brand protection strategy

  Following the launch of its orodispersible Levitra with 120 anti-counterfeiting features, Bayer gives some insight into its brand protection strategy.

• US import screening programme "back on track", says FDA chief

  The roll-out of a screening programme to ensure the quality and safety of medicines imported into the US is gaining momentum.

• IPEC report lays out US strategy on counterfeit medicines

  The US will not wait for a public health crisis before taking action to stem the trade in counterfeit medicines, according to IPEC.

• Keeping an 'Eye on the Ball': Oxfam responds

  A disproportionate amount of resources is being directed towards anti-counterfeit initiatives, says Oxfam in a response to our review of its 'Eye on the Ball' report.

• WHO must continue to lead fake medicines fight, says IFPMA's Pisani

  Eduardo Pisani, director general of the IFPMA, gives his assessment of the WHO discussions on addressing the health threat posed by fake drugs, and proposes a way forward.

• European Parliament adopts falsified medicines directive

  The European Parliament backs the Directive on Falsified Medicines, setting the clock ticking on a deadline of around two years for EU member states to implement the new legislation.

• Oxfam's trademark confusion

  Efforts by the USA and EU to fight counterfeit medicines are a thinly-disguised attempt to boost IP rules and pharma profits, claims Oxfam, but its conclusions do not stand up to scrutiny, argues Philip Stevens.

• AZ presses on with at-line mass serialisation

  AstraZeneca is stepping up its serialisation plans, with ten manufacturing sites and over 30 production lines generating packs with serial numbers at the start of 2011.

• EDQM traceability pilot moves towards live demo phase

  The EDQM is on course to start a lab-scale pilot of its medicine traceability system which should be ready for demonstration to stakeholders in the latter half of 2011.

• Drugmakers looking for track-and-trace across the supply chain

  The buzz around serialisation in pharma has hitherto been focused on protecting the downstream supply chain, but now drugmakers are also looking at the benefits upstream.