Functional Food and Nutraceutical Registration Processes in Japan and China: A Diffusion of Innovation Perspective

Abstract

Purpose - This paper looks into the functional food and nutraceutical registration processes in Japan and China. The Japanese have developed the Foods for Specified Health Use (FOSHU) registration process whereas the Chinese have put into place the Health Food (HF) registration process. The aim of this paper is to compare the regulation processes between the two countries in search for answers to three core empirical questions: (1) how have the registration processes developed and changed? (2) What are the similarities and differences between the processes of registration in the two countries investigated? (3) Why are the registration processes similar/different? Method – The study was conducted using secondary sources. The literature surveyed covered academic journals, trade journals, magazine and newspaper articles, market reports, proceedings, books and web pages of relevant regulatory authorities and regulatory consultants. Information from the more recently published sources was used preferentially over older sources. As well as using the most recent sources, information was selected on the basis of which source it was from. Official regulations and SFDA and MHLW websites would contain accurate and up to date information and information from here would be taken as true over other sources of information. Results - The two diagrams of the registration processes respectively in Japan and China clearly show that there are similarities and differences. There are six categories under which these can be found: (1) the scientific evidence required; (2) the application process; (3) the evaluation process; (4) the law and the categories of products; (5) the labels and the types of claims; and finally (6) the cost and the time involved. Conclusions -The data analysis suggests that the process of diffusion of innovation played a role in the development of the regulations. Further it was found that while Japan was at the outset a pioneer innovator in nutraceutical registration processes, there are indications that in more recent years it too imitated other countries.
 
 NOVELTY STATEMENT:
 
 The assortment of regulatory regimes creates much uncertainty for the firms and the lack of familiarity and poor knowledge of the regulatory situation increases the risk of failure. The research presented in this paper provides highly valuable information to any biotech/pharmaceutical/nutraceutical companies developing their market entry strategy in Japan and China. There are few national and international studies of drug registration application processes but even fewer comparative studies of functional food and neutraceutical registration application processes such as this one and none using a diffusion of innovation perspective.

Food-Derived Bioactive Peptides in Human Health: Challenges and Opportunities

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Chinese consumers’ willingness-to-pay for nutrition claims on processed meat products, using functional sausages as a food medium

“…Pretest results on top-five desirable benefits from processed meat products In China, the health (functional) food sector is administrated by the former China Food and Drug Administration (CFDA) (Yang, 2008). There are currently only 27 approved functional health claims to be made on foods by SFDA (see table below) subject to respective standard test procedures, requiring different test evidence on animals and/or on humans (Patel et al, 2008). In order to preliminarily understand the health benefits that were preferred in the specific context of processed meat, a pretest was conducted during a presentation by the author at University College Dublin campus under the topic of "consumer choice in economics and frontier of functional foods" on April 4, 2018.…”

Regulatory Environment and Claims – Limits and Opportunities

“…No systematic comparisons of the different systems have been published, with the exception of the comparison between China and Japan [9] for the whole process, and a comparison of USA, Canada and Europe for the scientific substantiation [10,11]. A systematic review is outside the scope of this paper, but some striking differences are highlighted in the following sections.…”