Features

• FDA to trial counterfeit detector via public-private alliance

  The US FDA has made its in-house counterfeit detector available for a new project to tackle counterfeit antimalarials.

• EU stakeholders move ahead with drug verification scheme

  EU drug industry moves closer to implementing a medicines traceability platform after appointing a key contractor.

• Novartis allegedly duped in anti-counterfeiting deal

  Novartis is investigating claims it was duped by anti-counterfeit tech supplier DataTrace DNA in a deal signed in 2010.

• Brazil opens public comment on traceability proposals

  Brazil's ANVISA published its proposals for medicines traceability today and opened a 30-day comment period.

• FDA seeks industry input on Internet monitoring

  The US FDA wants to hear from companies that may help it tackle illegal products such as fake medicines on the Internet.

• Drugmakers back Interpol in counterfeit medicines fight

  Drugmakers have clubbed together to support Interpol in the creation of a Pharmaceutical Crime Programme.

• NQR spectroscopy promising for fake drug detection

  Researchers in the UK have developed a portable device to detect fake drugs which could be superior to rival technologies.

• IoM backs track-and-trace to curb counterfeit medicines

  The US FDA should establish a track-and-trace system to help tackle the problem of falsified medicines, says IoM.

• PCSC says pharma cargo theft declined in 2012

  A pharmaceutical industry group says that theft of drug shipments in the US fell both in numbers and value terms in 2012.

• Viewpoint: Pharmacists caught illegally selling drugs

  Craig Stobie of Domino looks at how EU legislation will make it harder for rogue pharmacists to engage in illegal activity.

• California Board of Pharmacy hears comments on unique IDs

  California Board of Pharmacy discusses first amendments to its ePedigree legislation covering serialisation requirements.

• Report backs WHO's role in falsified medicines fight

  IFPMA report calls for WHO to take central role in in the fight against falsified medicines and other forms of pharma crime.

• Pilot aims to show feasibility of medicines traceability in US

  A pilot study has endosed the use of serialisation to support track-and-trace of medicines in the US supply chain.

• EU fake medicine seizures soar 700 per cent in 2011

  EU customs seizures analysis reveals interesting trends, such as a 700 per cent increase in fake drug shipments in 2011.

• US medical device sector gears up for unique identifiers

  The US pharma sector may have to wait a little longer for a federally-mandated traceability system for drugs, but things are moving quicker for medical devices...

• Track-and-trace left out of reconciled PDUFA

  The track-and-trace provisions that made it into the Senate version of the PDUFA legislation will not make the final cut as the House and Senate versions are reconciled, says Bill Fletcher.

• UK regulator launches new counterfeit medicine strategy

  The UK MHRA unveiled a new anti-counterfeiting strategy this week as it reflects on a successful five-year campaign against the trade in falsified drugs and medical devices.

• 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.