In this week’s news, FDA eyes blockchain for track and trace, CMOs under scrutiny, new FMD requirement in effect, and more…
US FDA wants to let drug firms test blockchain for track and trace
Blockchain can help secure US drug supply chains according to the FDA, which has outlined plans to encourage its use in track and trace.
The US regulator said, “We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain.”
To facilitate this, the agency launched a pilot programme to let drug makers test track and trace techs. The results will “inform the development of the enhanced electronic, interoperable track-and-trace system for industry set to go into effect in 2023 as part of the Drug Supply Chain Security Act.”
Blockchain technology refers to systems that create a permanent digital record of products each time they change hands, from API supplier to formulator to wholesaler and ultimately to end consumer.
Each transaction is referred to as a block and these blocks are chained together to create a record of the supply chain that everyone involved can access, but not edit.
US FDA focus on CMOs looks set to continue says inspection expert
The number of warning letter issued to contract research labs and manufacturing plants grew in 2018 according to an expert, who says the trend reflects the FDA’s greater focus on contracted activities.
Some 20 of the 127 warnings issued to firms involved in drug production by the FDA last year went to CROs and CDMOs according to analysis published by Pharmaceutical Online.
Author Barbara Unger, Unger Consulting Inc, said the increase – CROs and CDMOs received 11 warning letters in 2017 – reflected a shift in FDA inspection priorities.
“FY2018 warning letters continued to focus on contracted activities, a practice that, in my opinion, will continue into the foreseeable future” she wrote, adding “Five sites were located each in South Korea, China, and the U.S.; Europe had three sites and Australia had two.”
EU barcode and anti-tamper regs come into force
Since last Friday all pharmaceuticals sold in the EU must have a unique 2D identifier and an anti-tampering device on their outer packaging under the Falsified Medicines Directive.
The measure – which applies to all current member states excluding Greece and Italy where the deadline is 2025 – is one of a number of FMD requirements introduced in an effort to safeguard supply chains from fakes.
The Agency wrote, “The safety features will help protect European citizens against the threat of falsified medicines, which may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage and could potentially put patients’ health at risk.
“The unique identifier and the anti-tampering device on the packaging of the medicines will guarantee medicine authenticity for the benefit of patients, and will strengthen the security of the medicine supply chain, from manufacturers to distributors to pharmacies and hospitals.”
Manufacturers are required to upload ID data to a centralised repository which is, according to the EMA, “part of an end-to-end medicines verification system” introduced by the FMD.
Many UK pharmacies will not be ready for FMD says study
In related news, analysis suggests most UK pharmacies will not be ready for the barcoding requirements introduced under the EU Falsified Medicines directive.
Speaking to the Pharmaceutical Journal, Jerome Bertin, manager of SecurMed said less than half of all UK pharmacies have registered to access the UK National Medicines Verification System.
This is significant as the NMVS holds the data from FMD-compliant medicine packs that pharmacies will need to check product authenticity.
Read more here.
Also in the news
Science took a look at drugs approved by the US FDA in 2018. Author Derek Lowe says medicinal chemists should examine the molecules that win agency backing when screening their own compound libraries.
Gilead has halted development of an anti-BCMA cell therapy for multiple myeloma. FierceBiotech said Gilead’s decision to drop the KITE-585 CAR-T program reflects the increasing competition in the anti-BCMA category.
Pharmabiz reported that India’s Department of Pharmaceuticals’ decision to mandate that only products with bar coding on their packaging can be procured by Government programmes has attracted industry criticism.
Experts discussed the benefits of tracking regulatory developments in a RAPS feature article.
Research suggests bacteria dying as a result of exposure to an antibiotic absorb any antibiotic in their vicinity.