For a few years now, China has been building a library of documents that define standards for traceability, but no dates have appeared in any of them (see “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”, “China Posts New Draft Pharma Serialization Guidelines”, “China: NMPA Drug Traceability Guidance”, “China Commits To The Digital Future In Healthcare, Including Pharma Traceability” and “China Inches Closer To Another Pharma Serialization Mandate”). In a new posting on their website yesterday, the China National Medical Products Administration (NMPA) provided a notice of aggressive deadlines for vaccine traceability. Let’s take a look at it because a vaccine traceability mandate is probably a herald of a near-term future pharmaceutical traceability mandate.
Continue reading China Sets Aggressive Date for Vaccine TraceabilityMonthly Archives: December 2019
Japan Moves To Mandate Barcodes For Drug Traceability
Last week, the Japan Diet, the bicameral legislature, enacted a bill that amends the Pharmaceuticals and Medical Devices (PMD) Law there. From the limited information I have seen from GS1 Healthcare and from online articles I found through Google, it appears that one of the many things the new bill does is add a new barcoding mandate. Previously, barcoding of medicines and medical devices in Japan was only recommended.
Continue reading Japan Moves To Mandate Barcodes For Drug TraceabilityDSCSA: Industry Moves Forward
Some members of the US pharmaceutical supply chain are not waiting for the FDA to make the next move (see “DSCSA: Will 2020 Be FDA’s Year To Leap Forward?”). Instead, they are proactively organizing and setting the standards that will most likely be used to meet the requirements of the Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA), which goes into effect on November 27, 2023. Forward motion has been made over the last month on two fronts: The DSCSA governance organization and the Verification Router Service (VRS).
Continue reading DSCSA: Industry Moves Forward