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Understanding China’s Food for Special Medical Purposes Clinical Efficacy Testing Requirements

In the long term the use of FSMPs is likely to be included in China’s national health insurance scheme. As such authorities are prioritizing establishment of a strong regulatory framework to ensure the clinical efficacy and safety of FSMPs and their indications in the treatment of specific diseases.

Take home:

  • In the long term the use of FSMPs is likely to be included in China’s national health insurance scheme. As such authorities are prioritizing establishment of a strong regulatory framework to ensure the clinical efficacy and safety of FSMPs and their indications in the treatment of specific diseases.
  • Use of FSMP must be under the guidance of doctors or clinical dietitians and as such doctors will play an integral part in the promotion of FSMPs.

With a huge senescent population, the FSMP market in China has attracted many enterprises. The Chinese government has released “Administrative Measures for Registration of Foods for Medical Purpose” (became effective on 1 July, 2016), and its supporting documents (see CL news report on July 16, 2016) to regulate FSMPs. Requirements for clinical testing have aroused great attention from industry. During the 2016 food summit, the former vice-director of the Institute for Nutrition and Health of the Chinese Center of Disease Control Mr. Yang Xiaoguang was invited to introduce the rationale behind the new clinical trial requirements.

Emphasizing efficacy and nutritional Value

FSMPs are designed for patients with special nutritional requirements and are used in medical treatment. To ensure efficacy, the authority stipulated that FSMP registration should be assessed from a variety of criteria including efficacy data collected from clinical trials. Clinical trial data requirements are one of the most significant features of FSMP registration in China since it is not required in most foreign countries. As a borderline product FSMPs fall into a regulatory grey area which requires a blend of both food and pharmaceutical regulation. The major reason for China’s clinical trial requirements is that before China’s new Food Safety Law, FSMPs were imported under pharmaceutical registration. Another potential reason for clinical testing is that the government plans to include FSMP into the national health insurance scheme. Currently, Chinese national health insurance offers limited medical reimbursement but this will be expanded in future to possibly include FSMPs.

The role of doctors and clinical dietitians

The use of FSMPs will be restricted and must be used under the guidance of doctors or clinical dietitians. According to Mr. Yang, doctors and clinical dietitians will be fundamental in the promotion of FSMPs in China. Chinese doctors have in the past been implicated in unethically promoting the use of infant formulas at the expense of sound breast feeding advice and Chinese authorities are wary of fostering an environment that would promote a repeat of this unethical behavior. As such all FSMPs must be substantiated through clinical trials and have medically backed indications for use in a variety of nutritionally related diseases.

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