REGULATORY PERSPECTIVE FOR GENE THERAPY PRODUCTS IN THE USA, EU AND JAPAN AND FUTURE ASPECTS

Gene Therapy Products (GTPs) hold immense promise in revolutionizing medical treatments by altering genetic expressions to address various diseases. This study gives a summary of gene therapy products and their prospective uses, their historical development and several treatment options, as an in-depth exploration of the regulatory considerations for GTPs in the United States of America (USA), European Union (EU), and Japan, along with insights into future aspects of this field. A comprehensive discussion follows detailing the regulatory landscape and approval pathways in the USA, EU, and Japan. Programs that are exclusive to each area, such as PRIME (Priority Medicines) in the EU, USA's RMAT (Regenerative Medicines Advanced Therapy) designation and the Sakigake system in Japan are examined. Milestone meetings, approval requirements, and specific regulatory guidelines for GTPs in each region are also thoroughly covered. A list of approved GTPs and a glimpse into the future of the field. Anticipated trends include increasing investments, challenges related to production costs, expansion of manufacturing capabilities, and regulatory updates. The various regulatory strategies in each area and their efforts to balance patient access and safety will have a big impact on GTPs marketed in the future. Japan is well-positioned to maintain it’s as a global leader in regenerative medicine and cell treatments because of its favourable regulatory environment and government backing.

Medical treatments of necrotizing pancreatitis / 대한내과학회지

Pancreatic necrosis is associated with complications and mortality if the necrotic tissue becomes infected. The development of necrosis is associated with hypovolemia, vascular spasm and hemoconcentration. Control of hypovolemia, use of antibiotics, nutritional support and endoscopic treatments are the nonsurgical options in the mamagement of necrotizing pancreatitis. The proper use of antibiotics in acute pancreatitis remains controversial, however, current evidence favors the use of prophylactic antibiotics in necrotizing pancreatitis. Enteral feeding is usually well tolerated, however, total parenteral nutrition may be necessary. Several studies have demonstrated that enteral feeding via a nasojejunal tube infused distal to the ligament of Treitz is associated with a decreased rate of complications, including infection, when compared to total parenteral nutrition. Infected pancreatic necrosis can be managed by percutaneous or endoscopic dranage. The choice of drainage routes depends on the disease status, availability of the interventional radiologist or gastroenterologist. For improvement of outcomes and reducing complications in the management of necrotizing pancreatitis, proper patient selection and technical expertise are required.

Development and Design of Simulation System for Medical Treatments on Hospital Ship / 医疗卫生装备

Objective To design and implement a dynamic simulation system for medical treatments on hospital ship, the application of which can provide evidence for the tactical and technical index of the equipment and the research on medical treatments. Methods Queuing theory and discrete events imitation methods were applied to make research on how to simulate random arrival of the sick and wounded of corresponding various random pattern, organizing of medical resources and medical treatments as well as procedures and rules of medical treatments by means of establishing overall system mathematics model on condition that the amount of the wounded and different distribution of wound type was given. Results The process data and outcome data of medical treatments such as passing ratio were achieved under different running circumstances in the given time. Conclusions The system can imitate the large-scale medical treatment process which can rarely implement many times in reality, meet different needs flexibly, and provide optimization foundation to medical resources configuration on medical ships.