Up to now, dozens of medical enterprises are registering and applying for food for special medical purpose, and there are more than ten medical enterprises supplying food for special medical purpose in the market. However, in the transcripts submitted by medical enterprises, it is difficult to see the outstanding performance of food for special medical purpose. Is it a wise choice for medical enterprises to deploy food for special medical purpose?

Enterprises speed up the layout, but the profit situation is not clear

Food for special medical purpose means formula foods that are specially processed and prepared to meet the special requirements of nutrition or meals for people with restricted eating, disorder of digestion and absorption, metabolic disorder or special disease status. At present, the profitability of medical enterprises that deploy food for special medical purpose in this business is not yet clear.

A medicine salesperson said that there are strict standards for medicines entering the hospital, and there is also supervision of the related departments in terms of price, which is excluding food for special medical purpose, making some hospitals afraid to sell them. Compared with the revenue of medicine, food for special medical purpose play little role in the growth of revenue of medical enterprises.

However, in the eyes of industry insiders, medical enterprises have unique advantages in making food for special medical purpose. Some experts said that food for special medical purpose is required high technical, strict processes and relatively complex production progress. Compared with food enterprises, medical enterprises' advantages in medicine production can take the lead in this field. Furthermore, food for special medical purpose is currently mainly sold and consumed in hospitals. Even if it is not used in hospitals, patients need to consume it under the guidance of doctors or nutritionists. Medical enterprises can rely on their inherent sales channels to lead in the sale of food for special medical purpose. However, in the financial reports and sales data of medical enterprises, food for special medical purpose has not become a source of profit.

High market threshold makes it difficult to sell

In 2015, food for special medical purpose begin to be regarded as food, which has been regarded as medicine before. Now the production progress is also compared with that of medicine, where there is a high cost of research and development and complex clinical trials are required. In addition, China's supervision for food for special medical purpose is also constantly increasing. 19 provinces (regions and municipalities) have issued normative documents or carried out special rectification actions on food for special medical purpose, and made great efforts to rectify food for special medical purpose and food safety.

At the same time, if medical enterprises enter the field of food for special medical purpose, they have to bear high risks of food safety. Recently, the State Administration for Market Regulation has publicly solicited opinions from the society on the Measures for the Management of Risk Ranking of Food Manufacturers (Draft for Comments), in which the static risk factors of food manufacturers are divided into Grade I, II, III and IV according to quantitative scores. files. Among them, special foods such as health food, food for special medical purpose and infant and young children formula belong to high-risk foods and are classified as the highest Grade IV.

Relevant staff the Food and Drug Administration said that there are many enterprises registering food for special medical purpose, but few have passed the registration. One is that many enterprises use the formulas of health food to register and produce food for special medical purpose, and the other is stricter standards for food for special medical purpose specially developed for diseases in terms of clinical trials, so the approval time will be longer. In addition, China has set high thresholds and standards in terms of registration requirements, R&D and production, whole-item inspection and GMP plant equipment of food for special medical purpose. The production workshops of some foods for special medical purpose also need to achieve a sterile state that does not contain pathogenic bacteria and toxins that endanger public health, which also requires enterprises to have sufficient economic strength and be able to take higher risks.

Relevant reading

l  China Proposes to Speed Up FSMPs Assessment Process

l  Interpretation | Measures for the Registration of FSMP (Draft)

l  Analysis of Current Situation of FSMP Industry in 2021

Source: China Business Herald

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