Former CFDA Special Food Director Explains China’s FSMP Policies

On April 19, 2018, Wang Hong, former director of CFDA Department of Special Food Registration, gave a keynote speech on food for special medical purpose regulations (FSMP) during Food and Beverage Innovation Forum 2018 (FBIF2018).

China’s FSMP industry now has over 3,000 FSMP manufacturers whose target customers are people with medical conditions which require specific dietary interventions. According to Wang the development of the industry is being hindered by four major challenges namely: vague market niche (overlap with other product categories like health foods, foods for special dietary purposes etc.), flawed product standard, unclear clinical testing method, and inadequate regulation. Regarding FSMP clinical testing, Wang disclosed that CFDA had sought public consultation on four methods, two of which are expected to be introduced in the short term.

At present, FSMP regulation is stricter than general foods but not as stringent as pharmaceutical drugs. The management framework of FSMPs can be broadly divided into three parts.

• First, laws and regulations: SAMR is now revising Regulations on the Implementation of Food Safety Law (food safety law implementation rules) and when officially promulgated we can expect detailed clarification on regulation of FSMPs;

• Second, standards and technical criteria;

• Third, documents updated on the CFDA website.

To further aid our understanding of FSMP regulation we can divide market access into 5 distinct steps (both pre and post market):

• Registration (Dossier inspection to substantiate clinical efficacy, safety, quality indexes, ingredients etc.)

• Label management

• Licensing

• routine inspection  

• market product sampling

Registration, licensing and routine inspection are closely linked and have to be in consistent. Although routine inspection has not been widely carried out yet, it will constitute an essential link. Market sampling focuses on the content and labeling of products only. Wang finished her speech by outlining that the ultimate policy agenda was to develop FSMP regulations which are built on scientific principles and ensure consumer safety and product efficacy.

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Administrative Measures for Registration of Foods for Special Medical Purpose

GB 29922-2013 National Food Safety Standard General Rules for Foods for Special Medical Purposes

Recent Updates of China’s FSMP Registration Rules