Serialization will be a global requirement by 2018. Our Blockchain Drug ID (BDID) is one of the best solutions for US, EU, China, and Brazil's Track and Trace Regulations. BDID system can track and trace to the final unit, pill, of the drug supply chains.
BDID uses Blockchain’s anti-forgery, multi-ledger, huge ID numbers (2^256), independent management, and multi-confirmation to comply track and trace globally.
BDID uses Blockchain, mobile APP and internet to achieve:
☒ Drug identification
☒ Drug tracing
☒ Drug verification
☒ Detection and Response
☒ Instant Reward
BDID provides the real-time opportunity to review data and analyze drug track to capture business value, create revenue and increase ROI.
Patients can use mobile APP to scan drug QR Code. This drug QR Code contains the multi-Sig and encrypted keys that can be cross-confirmed the drug records through internet with Pharmaceuticals.
Drug encrypted key needs to match the Blockchain correspond key to confirm the legal status of the drug. This information will be analyzed based on pill lot number, expiration date, potential side-effects, and other available information of multi-drug regimen.
After the data analysis completed, the BDID system will immediately inform the patient of the efficacy of the pill, medication safety and other warning. BDID will also remind the patient medication schedule to keep the efficacy of regimen. BDID APP will display the report and chart of analysis based on big data.
All collected information including the use of the pills, the frequency, and the dosage of individuals, and regions is for big data analysis. After the patient's consent, the data may be provided to the medical staff or Specific Institutional Reference.
The full complement of US requirements phases in between 2015 and 2023, with challenges for all supply chain companies at different points along the way.
With the 2015 Drug Supply Chain Security Act (DSCSA) lot-level traceability deadline behind us, pharmaceutical companies have turned their attention to full drug serialization. DSCSA requires that manufacturers mark packages with a product identifier, serial number, lot number, and expiration date by November 2017. Given everything that needs to happen by then, from altering highly regulated packaging and distribution processes to addressing enterprise-wide IT, pharma companies should be well on their way to readiness. At the same time, wholesale distributors and other supply chain companies will perform end-to-end serialization testing with their manufacturing partners in advance of the deadline to allow time for any necessary adjustments.
With the publication of the Delegated Act on safety features, those who manufacture, sell, or dispense medications in the European Union have until February 2019 to comply with new track and trace regulations outlined in the Falsified Medicines Directive (FMD).
FMD compliance creates some unique challenges. The main requirements presented in the FMD involve serialization, compliance reporting, and verification. Medications in Europe are generally packaged and sold at the “unit of use” level, so the volume of product that needs to be serialized and the magnitude of transactions will be two to five times what companies will see in the U.S. where the saleable unit is in larger bulk quantities. Overall, the universe of data to be produced, managed, and reported on will be massive, with the added complexity that each EU Member State is provided flexibility to apply their own unique requirements.
China has had a phased implementation of their track and trace regulations based on therapeutic drug class, with 2013 and 2014 deadlines covering select products on their Essential Drug List. As of China’s final December 31, 2015 deadline, however, all pharmaceutical products will be covered under China’s unique requirements, which include serialization and government reporting.
Companies selling drug product in Brazil face particularly challenging regulations, with requirements for serialization, traceability, verification, and government reporting. A long-debated regulatory bill, PL 4069, was used as the basis for the new law, No. 13.410, which was officially signed into law and published on December 28, 2016 – setting the wheels in motion for Brazil’s multi-stage implementation. This new law, which amends the previous regulation in Brazil, is based on extensive industry stakeholder feedback.
Blockchain Drug ID (BDID) achieves the ultimate goal to track and trace the final unit, pill, of the drug supply chains with tiny cost of Internet of Things ( IOTs). The advantages of BDID are as follows:
Estimates on the size of the global counterfeit drug market range from $75 to $200 billion. It is estimated that 10–15% of the global drugs supplied are counterfeit. The prevalence is higher in developing countries in Africa and in parts of Asia and Latin America where up to 30–60% of drugs on the market are counterfeit.
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