On March 21, the official website of China Food and Drug Administration announced that the registration of one formula food for special medical purpose in one enterprise has been approved. This is the fourth batch of catalogue list published since the special medical food registration system in March 2016. So far, a total of 6 products have been approved:


From the categories of registered products, these 6 products are special infant formula food for baby of 0~12 months old, of which 3 are lacto protein partial hydrolysis formulas, 1 amino acid formula, 1 lactose free formula and 1 amino acid metabolic disorder formula (phenylketonuria). From the perspective of enterprises, of the six registered products, two were successfully registered by the SHS UK Company, two by Abbott (Spain) Company, and the rest two by Beingmate (Hangzhou) Company and Mead Johnson (Holland) Company respectively.

The development of domestic special medical food itself is relatively backward, and the response of foreign enterprises to China supervision policies and regulations requires a relatively long time, combined with that the period required by clinical trials, etc. for specific full-nutrition formulations is relatively long, for various reasons, although there are still 9 months left until the end of the transition period, there are still no special medical foods for people over 1 year old approved. How long do the groups in special medical conditions have to look forward to, and will the transition period be extended for these groups? Let’s continue to pay attention.