Administrative Measures for the Registration of Formula Food for Special Medical Purposes.

The Purpose of these Measures is to regulate the registration of formula foods for special medical use, strengthen registration management, so as to ensure the quality and safety. The Measures consist of 52 Articles divided into 7 Chapters: General provisions (I); Registration (II); Clinical trials (III); Labels and instructions (IV); Supervision and inspection (V); Legal liabilities (VII); Supplementary provisions (VII).
Chapter 2 provides for the conditions, procedures and requirements to be satisfied for the application, acceptance, examination and renewal of the registration. The Measures shall be applicable to the registration and administration of formulated foods for the special medical application that are produced and sold within the territory of the People's Republic of China and those imported.