The Unified Identification Protocol encompasses several patents. In addition to patents already granted in the USA, such as the Unified Identification Protocol for training and health and the Universal Identification Method for Legal Procedures and Legal Documents, a new patent has been granted for the universal identification of clinical trials, patients (human and animal), biological medicinal products (of human, animal, or plant origin), and clinical, veterinary, and research personnel (see https://ppubs.uspto.gov/dirsearch-public/print/downloadPdf/20210183479).
The Unified Identification Protocol enables the universal registration and identification of clinical trials, the centers where they are conducted, clinical and research personnel, as well as clinical and legal documents, and biological products of human, animal, or plant origin.
This new patent facilitates a universal registry for the global identification and traceability of biological origin products, a unified global register of clinical trials, a unified registry of organizations manufacturing biological medicinal products, and a universal identifier for patients and donors (human or animals).
A biological medicinal product is defined as a product whose active substance is a biological substance, produced by or extracted from a biological source. Starting materials for biological medicinal products include substances of biological origin such as microorganisms, organs and tissues from plants or animals, cells or fluids (including blood or plasma) from humans or animals, and biotechnological cell constructs, whether recombinant or not.
Achieving complete cross-border traceability among different territories necessitates labeling systems and regulations that ensure universal traceability from the origin of biological products (obtention or manufacture) to the batch of products and their use, as well as the ability to notify intermediaries using biological material of any events affecting product quality or safety. The principles of Quality Risk Management (QRM) are paramount in ensuring quality control. Furthermore, data necessary for complete traceability must be retained for at least 30 years in some countries.
In conclusion, the Unified Identification Protocol represents a significant advancement in the traceability and regulation of biological medicinal products, ensuring global standards for quality, safety, and efficacy in healthcare and research.
