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Overcome Regulatory Compliance Challenges in Life Sciences with Blockchain

By Life Sciences Review | Wednesday, January 06, 2021
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A blockchain-based solution will add transparency and accountability to the pharmaceutical industry's supply chain, making it cheaper for regulatory agencies to monitor pharmaceutical products.


FREMONT, CA: Healthcare laws differ across topography, so international corporations need to comply with foreign and local regulatory approval criteria. In this case, an approach to mastering enforcement by applying a hybrid blockchain can be constructive. Blockchain technology provides a means of storing and sharing information over a secure peer-to-peer network. Multiple network users check both blockchain knowledge transactions. This aspect makes it possible for regulators to determine the reliability of the documents.


Below is how Blockchain can solve some of the most troubling regulatory and enforcement problems in the life sciences industry today.


1. Pharmaceutical Supply Chain 


Counterfeit drugs are one of the most significant problems facing government authorities and pharmaceutical firms. Main concerns related to the safety of medicines in the pharmaceutical supply chain contribute to how medications are produced and the traceability of active pharmaceutical ingredients. The pharma supply chain's data and processes are frequently contradictory, contributing to little or no visibility of end-customer sales data for producers. 


Analysis by a public health organization showed that at least 10 percent of medicines worldwide are counterfeit, resulting in 1 million deaths per year.


A blockchain-based solution will add transparency and accountability to the pharmaceutical industry's supply chain, making it cheaper for regulatory agencies to monitor pharmaceutical products. Blockchain-based information systems can carry data such as expiry dates and certificates of origin that can be made available to all regulatory parties at each point of the drug's journey.


2. Subject Identification for Positive Clinical Trials


The desire to identify the best candidates for clinical trials is a central element in the successful development of medications. Every patient or topic is unique, and, thus, it is crucial to provide a single source of reality for every person within the network. Incorrect choice of the issue due to lack of correct patient details can lead to failure of clinical trials and, eventually, to delays in drug launches and notable monetary losses that indirectly affect cost-to-care prices.


Blockchain can help patients preserve their medical records and reach out to clinical trial recruiters themselves, while investigators and clinicians can save their findings on the same chain. In this way, patient data would be protected, untouched, and open to the right partners by role-based access.


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