Contain Medicinal Active Ingredients Hemostatic Dressing Principle Of Safe And Effective Research

Blood is tightly related to the organs through circulatory system, and it is involved in various body functions such as respiration, transportation, defense, regulating body fluid osmotic pressure and acid-base balance and other physical activities. Blood has an irreplaceable role for the maintenance of normal body metabolism and the balance of internal and external environments. If the bleeding does not stopped timely, then this will easily lead to shock and even life-threatening. Hemostasia is such important not only for the army but also for public health. Various wound dressings have different effect and such dressing with drug additive is attracting the eyesight for its high efficiency. Wherever, researchers had put too much on its efficiency and ignored its safety at some stage. In addition, some researchers were not familiar with market permitting regulations which might leads to the failure.It is worth to study the foundation stone of such phenomenon. On the one hand, medical device supervise in china has started latterly and the guidance needs to be developed and progressed, on the other hand, people know a little about the nature and special control is also absence about the safety risks. Based on above considerations, the study starts from regulatory and technical levels, learns the experience from other advanced countries, and combines with China’s development reality in an in-depth discussion. This discussion is related to the determination for the product’s type and attributes, technical performance requirements, risk control measures, and market access principles. The study proposes relevant technical requirements for bleeding-stop dressings containing active pharmaceutical ingredients (API) and their market-access principle framework, so as to provide a reference for product development and marketing, technical review, and relevant departments that formulate make-access principles and requirements.1. Through the comparison among medical equipment regulatory systems in different countries, the study presents relevant principles to determine types and attributes of hemostatic dressings containing the active pharmaceutical ingredient;2. Through the discussion on characteristics and hemostastic mechanisms of dressing products, the study presents basic technical requirements in three aspects, namely, physical, chemical, and biological so as to ensure the products are safe and effective;3. Through analysis on in the viral infection/immunogenic risk in production processes, the study presents systemic measures to prevent safety risks for bio-derived raw materials;4. Through analytical comparison of relevant market-access principles between China and other advanced countries, the study presents the principal frame of the market access in such aspects as the biological assessment, animal testing, clinical trials, marks, and labels.