Do not account for the proportion of drugs, special medical food will impact hundreds of millions of markets!

The so-called special medical use formula food, refers to meet the eating restrictions, digestion and absorption disorders, metabolic disorders or specific disease status of the special needs of the population for nutrients or diet, specially processed formulated food. Includes special medical-purpose infant formula for 0-month to 12-month-olds, and special medical-purpose formula for people over 1 year of age.
special medical use formula food does not account for the proportion of drugs, which contains huge market opportunities, the relevant policy system changes have also attracted the attention of the industry.
fact, the registration policy system for special medically used formulated foods is going through a process of gradual improvement. From the Measures for the Registration and Administration of Special MedicalLy Used Formulated Foods issued in March 2016 (Order No. 24 of the State Food and Drug Administration), to the Code of Quality Management (Trial) for Clinical Trials of Special MedicalLy Used Formulated Foods issued in November 2016, to the September 2017 Issued Announcement on the Applications and Requirements for registration of Special Medical Uses Formulas (Trial) (2017 Remnives) and the Research Requirements for the Stability of Special Medical Uses Formulas (Trial) (2017 Responsication) (No. 108 of 2017).specific whole-nutrition formula is the growth point
the so-called whole-nutrition formula, refers to a single source of nutrition can meet the nutritional needs of the target population of special medical use formula. A specific whole-nutrition formula is a special medical-purpose formula that can be used as a single source of nutrition to meet the nutritional needs of the target population in a particular disease or medical condition.
is more professional, more acceptable to clinicians, and easier to set product thresholds than other special medical-specific formulations, specific whole-nutrition formulations combined with specific diseases.
foods commonly found in specific whole-nutrition formulated foods mainly refer to the 13 foods specified in Appendix A of the National Standards for Food Safety for Special Medical Uses (GB29922-2013). As shown in Table 1, the current scientific evidence is sufficient, the application of a long history of 8 specific whole-nutrition formula foods have identified its whole-nutrition formula on the basis of adjustable nutrient content technical indicators.
And in view of liver disease patients with whole-nutrition formula food, muscle decay syndrome patients with whole-nutrition formula food, trauma, infection, surgery and other stress state patients with whole-nutrition formula food, gastrointestinal absorption disorders, pancreatitis patients with whole-nutrition formula food, and fatty acid metabolism abnormal patients with whole-nutrition formula food related adjustment evidence is not sufficient, has not yet established its nutritional adjustment range.
clinical trials are required for specific whole nutritional formula foods. According to the regulations, in order to ensure that there are enough research cases to carry out safety evaluation of experimental products, the test group is not less than 100 cases. The observation time should be set reasonably according to the research purpose and the biological characteristics of the main laboratory test indicators to be examined, in principle not less than 7 days, and the observation indicators of nutritional adequacy and clinical effects for special medical purposes should be clinically meaningful and meet statistical requirements.the impact on nutritional drugs
special medical use formula food formulation combination is mainly amino acid products, and is prohibited for extraintestinal nutrition support and intravenous injection. It is expected that the primary impact of special medical use formula food is amino acid oral drugs, in 2016 corresponding to the sample hospital market size of about 60 million yuan. Among them, lysine and vitamin compound oral medicine is expected to be the biggest impact, the corresponding manufacturers of such products should actively layout special medical use formula food.
2016, intestinal nutrition support and intravenous drugs have been monitored and used, and medical institutions have increased restrictions on the proportion of nutritional drugs. The launch of special medical-purpose formulated foods is also expected to impact intestinal nutrition support and intravenous drugs, which were sample hospitals with a market size of just over 100 million yuan in 2016.the >>>
special medical use formula food does not account for the proportion of drugs, the market potential is large. However, there is no "national food note TY" at the beginning of the special medical use formula food registration number was approved, medical institutions centralized procurement plan also did not develop relevant policies for special medical use formula food, how the future health insurance matching is also unknown.
The sales prospects for special medical-purpose formulated foods as fresh are not clear, especially since special medical-purpose formulated foods need to be used in medical institutions with nutrition departments, but not all medical institutions currently have nutrition departments.
the most active manufacturers of special medical-purpose formulated foods, will be companies whose product structure itself has nutritional drugs. However, if the product threshold is not established, competition is expected to be fierce and future market growth will be in specific whole nutrition formulations. (Medical Economics)