It is understood that in March 20th, the fourth batch of special medical food registration directory information was released. At this point, a total of 6 products of 4 enterprises have obtained special medical registration certificates, of which 5 are imported and 1 are domestic products. All of them are infant formula products for special medical use. At present, the time limit for the transition period of registration of special medical products from 1 to January 2019 is getting closer and closer. How to successfully get the certificate of registration is the most concerned problem for many special medical food enterprises.
Great potential and much difficulty:
With the national food safety strategy and the implementation of the National Nutrition Program (2017-2030 years), as the new "blue sea" of the large health industry, the special medical food industry is gradually moving towards the key period of development. Data show that from 2011 to 2017, the demand for special medical food in China rose from 6 thousand and 500 tons to 36 thousand and 600 tons, and the output of special medical food also rose from 2 thousand tons to 24 thousand and 700 tons. Special medical food has a great potential for development.
The nutritional support methods such as enteral nutrition and tumor nutrition have attracted more and more attention, and the implementation of clinical nutrition intervention has been incorporated into the "Health China 2030" program. As a nutritional supplement, special medical food can play a role of nutritional support. "Therefore, there is still much room for development of special medical food in clinical application."
In spite of the bright future, the road is still bumpy. Liu Xuecong said that the overall declaration of the registration of special medical food in China is not large. Up to now, no more than 100 products have been applied for registration in accordance with the "special medical use formula for the registration and management of special medicine". According to the current regulations, when applying for registration, special foods need to provide materials that indicate the safety, nutritional adequacy and clinical effects of special medical uses. Enterprises that apply for registration of specific full nutrient formula foods should also submit clinical trial reports. "The current situation is that there is a big gap with the requirements of registration, whether it is the data preparation of the registration declaration, the design of the product formula, the production process and the production process." Liu Xuecong said that this led to the fact that the number of products currently registered is still relatively small, and most of them are concentrated in infant formula products. In this regard, he stressed that enterprises can not be blind to registration optimism, to do a good job of long-term coping difficulties, the registration application materials and research and development data preparation work to do more fully.
Problems can be solved：
Many industry experts believe that the implementation of special medical food registration and filing system may slow down in the short term. For the enterprise, obtaining the formula registration does not mean that the product can be once and for all, but not the quality of the product. How to ensure the basic research, formula design, research and development, clinical trial and circulation application of the product is consistent with the effectiveness, safety and standardization required by the relevant laws and regulations. It is a special medical food enterprise. The common problems facing the industry.
In the transition period, facing the strict supervision of special medical food and the homogenization of products, how to effectively utilize the standard and protection of the new policy, break the monopoly of foreign special medical food and stand out in many homogeneity products will become a new challenge for Chinese special medical food enterprises.