China Food for Special Medical Purposes: New Clinical Testing Requirements

1. Clinical testing is required for the registration of nutritionally complete foods for special medical purposes (FSMP) with a specific formulation. 2. Only the manufacturers of domestic and overseas FSMPs can register a FSMP.

On Jan. 7, 2015, China Food and Drug Administration (CFDA) notified WTO of the updated draft of “Administrative Measures for Registration of Foods for Special Medical Purpose”, which will be open to comments from WTO members for 60 days. The final version is expected to be published within the first half year of 2016.

China FSMP Premarket Guideline
Administrative Measures for Registration of Foods for Special Medical Purpose

Foods for Special Medical Purpose can mainly be divided into three categories, i.e. nutritionally complete foods, nutritionally complete foods with a specific formulation, and nutritionally incomplete foods. Clinical testing is required for nutritionally complete foods with a specific formulation, and clinical testing reports shall be issued by qualified testing agencies, including complete statistical analysis report and data.

The main content of the WTO version remains the same as the previous version (see CL report on Sep. 2, 2015), the important information of which has been selected as below:

Competent authority	CFDA
Affected products	Domestic and imported FSMPs
Applicant	Manufacturers of domestic and overseas FSMPs
Registration dossier	Application form Product R&D report and product formula and relevant evidences Production process Product standards and requirements Product label and users’ directions Sample test report Materials proving the capabilities of R&D, production and inspection Other materials proving the product safety and nutrient sufficiency
On-site inspection required?	Yes