The most exciting thing happening lately with the Drug Supply Chain Security Act (DSCSA) is the setting up of a new non-profit organization aimed at coordinating the development of “…a comprehensive shared vision for interoperable drug tracing...” so all companies can comply in 2023 and beyond (See “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability” and “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders“). The Pharmaceutical Distribution Security Alliance (PDSA) initiated the development of that new organization last year and we now have its name: The Partnership for DSCSA Governance, Inc., or PDG. I am told their website will be set up in the next few weeks, so until then, I have posted several of their public documents for RxTrace readers. Let’s take a look at them.Continue reading The Partnership for DSCSA Governance Is Up and Running
Happy New Year! 2020 is going to be an important year for the industry to work with the FDA to figure out how the 2023 requirements of the Drug Supply Chain Security Act (DSCSA) will be met. A lot has to happen, and so far, the industry is making the right moves to make it happen. The question is, will the FDA join them in time?Continue reading 2020: The View Ahead
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 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 Traceability
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
If you do business in Brazil then you know that everything is published there in Portuguese, including ANVISA’s documents. It is necessary to translate everything unless you can read Portuguese. I can’t, so whenever something comes out I have to do a quick translation to get an idea of how significant it is. Last week, ANVISA published two new documents related to their future pharma serialization and traceability mandate. They are important, because they relate directly to the schedule and some of the requirements of Brazil’s pharma serialization and traceability mandate.Continue reading Brazil Moves to Formalize A Phased Rollout, Starting Next October
When it comes to the Drug Supply Chain Security Act (DSCSA), the FDA seems to alternate between hibernating, and leaping forward. 2017 through mid-2018 was a leap forward period with the publication of 8 draft or final guidance documents and 3 public meetings. Then in 2019, hibernation. Yes, FDA’s list of DSCSA guidance and policy documents has two entries for 2019 so far, but one is simply a notice reopening the comment period on the DSCSA Pilots request for information that was originally opened in 2016 and 2017. The other is the compliance policy that provides one year of enforcement discretion for the 2019 wholesaler saleable returns requirement (see “No Surprise: DSCSA Verification Delay”). Neither were very taxing on the FDA to prepare. What should the FDA do next? What should they be doing right now?Continue reading DSCSA: Will 2020 Be FDA’s Year To Leap Forward?
We’ve seen this sequence of events before in China, Brazil, and India, and now they may be happening in the Russian Federation. The government issues regulatory requirements mandating pharma serialization and tracing with crazy-aggressive deadlines and with confusing, sometimes illogical requirements. Amendments are issued, sometimes helping, sometimes making things worse. Then just before (or just after) the deadline, when confusion reigns, someone else in the government issues calls for rationality, and the government quickly folds their requirements, rethinks and retrenches. In China and Brazil it resulted in a full withdrawal and total redesign of their entire approach…and much more reasonable deadlines. So far in India it has mostly just resulted in pushing the deadline out, again and again, but even there, there are signs that some are proposing a complete withdrawal and redesign. So far in the Russian Federation, all we have is the posting of a set of very rational recommendations by a group of participants in parliamentary hearings of the State Duma Committee on Health Protection. Their hearings were apparently related to the spotty readiness of the government and industry and their report comes less than 3 months from the deadline for serialization and tracing of all drugs.Continue reading Russia: Rationality Makes An Appearance at the 11th Hour. Will It Matter?