On June 26, 2018, the State Administration of Market Regulation(SAMR) approved the registration of two FSMP formulas for one enterprise.
Both products are Abbott's premature/low birth weight infant formula, and the product information is as follows:
At present, 8 FSMP have been approved, all for special infants under 1 year old. Now covered in five categories, including lactose-free formula, partial hydrolysis of milk protein, amino acid formula, premature/low birth weight infant formula And amino acid metabolism disorder formula.
Prior to this, the former China Food and Drug Administration (CFDA) official website announced that a total of six special medical use formula products were approved.
The development of domestic FSMP is relatively behind, and the response of foreign companies to Chinese regulatory policies and regulations requires a relatively long period of time, coupled with the long period of clinical trials required for specific full-nutrition formulas. From the currently approved list, there are still no FSMP for people over the age of 1 to be approved.
How long will the group in special medical conditions still have to wait?
