With China’s Moves on Regulating Health Foods, What is New in the Recently Released Rules?
Substances regulated as dietary supplements in the U.S. are referred to and regulated as “Health Foods” in China. In June 2016, the China Food and Drug Administration (CFDA) announced Administrative Measures on Health Food Registration and Filing[1] (AMHFRF) which initiates a dual-track procedure for any health food manufacturer to apply for their products to be recognized by CFDA and sold in China. For foreign dietary supplement manufacturers that import their products to China, if the products are imported into China for the first time, they need to go through the registration procedure unless their products are vitamin and mineral supplements as listed in the Catalog of Raw Materials for Health Food (the first batch)[2], which are eligible for the more simplified and shortened filing route.
After AMHFRF was announced, there have been questions regarding details on how to apply the rule’s requirements into practices. Legal and regulatory professionals expected that CFDA would soon provide more detailed rules and regulations at the operational level.[3] In November 2016, CFDA responded in a fast way by announcing the Detailed Rules on Health Food Registration Review and Approval Process (2016 Version), and in December, 2016, the Guidance on Health Food Registration Applications (2016 Version). Subsequently, on February 6th, 2017, CFDA released the draft of Detailed Rules on Health Food Filing Process (2017 Version) requesting comments by February 28th, 2017. So what has been covered in these three recently released documents? Below is a synopsis of CFDA’s requirements and expectations, and how they apply to health food manufacturers not based in China but interested in the Chinese market.
Differences of focus for the three recently announced rules and guidance on health food registration and filing from CFDA
The AMHFRF generally builds up a framework on what products the registration and filing processes cover, respectively, and what information is needed to submit a registration or filing application.
The Detailed Rules on Health Food Registration Review and Approval Process (2016 Version), as can be seen from its title, heavily focuses on how the technical review of health food registration is organized. Specifically, the rule explains how the expert committee responsible to review and advise CFDA on whether to approve an application or not is set up, what working procedure the whole review process follows, and what judgment criteria the expert committee uses to make a decision. For example, it demonstrates what kind of evidence of safety the safety expert committee is seeking when reviewing the application.
The Guidance on Health Food Registration Applications (2016 Version) is like a hands-on instruction manual for any submitter of health food registration. It is more focused on the procedure each submitter should follow. The procedure involves the online steps of filling out registration forms, and the offline steps of preparing hardcopies of registration documents, which requires one original and 9 sets of copies. This guidance also describes in general what information CFDA is looking for in each subcategory of materials needed for the procedure. For example, in the product R&D report, there should be four sections: (1) product safety, (2) efficacy, (3) technical aspect and manufacturing process and (4) product specification. Under each of these sections, detailed requirements within the section follow as specified in the guidance.
Different from the previous two documents’ focus on health food registration, the draft of Detailed Rules on Health Food Filing Process (2017 Version) specifically addresses health food filing. Due to the more simplified nature of the filing process, no expert review committee is involved, nor does it require substantial evidence of safety (toxicology) and efficacy. This rule describes both the general procedure of filing and details of what CFDA is looking for in filing documents.
Updates in the Detailed Rules on Health Food Registration Review and Approval Process (2016 Version), compared with the previously announced administrative measures (AMHFRF)
As mentioned above, this rule explains in details the structure, working process and judging criteria of the expert review committee. Corresponding to the four sections required in R&D report of the registration application, the expert review committee is made up of four groups to review each of these aspects of an application: product safety (at least 7 people, with formulation, toxicology and technical experts), efficacy (at least 7 people, with formulation, product function and technical experts), technical aspect and manufacturing process (at least 3 people, with technical aspect and manufacturing experts), and specifications (at least 3 people, with experts in the area of physics, chemistry and standards).
The review process first starts within every group, and then each group leader presents the summarized report. In the case of any interdisciplinary issues arising, cross-functional meetings will be held among different groups. If there is no consensus achieved by 2/3 of experts attending this cross-functional meeting, a third step, an expert discussion meeting will be held[4]. If an agreement cannot be reached among at least 80% of experts presented at this meeting, then the committee would recommend CFDA not to approve the product.
Updates in the Guidance on Health Food Registration Applications (2016 Version), compared with the previously announced administrative measures (AMHFRF)
This guidance provides a section of terms and definitions on what CFDA is looking for in application components, such as literature evidence, experimental evidence, safety evaluation trials, efficacy evaluation trials, stability studies, etc. Additionally, it describes what is needed under each subsection of application components. For example, among the four sections required in the R&D report (safety, efficacy, technical aspects and manufacturing process, and specifications), the safety part should include the evidence that supports the use of each ingredient including technical additives such as processing aids, any safety evidence on the product formula, ingredient combination and usage levels, analysis and evaluation on safety trials, population that the product is suitable or unsuitable for, recommendations of use, use level, any precautions, etc.
Updates in the draft of Detailed Rules on Health Food Filing Process (2017 Version), compared with the previously announced administrative measures (AMHFRF)
This rule describes the entire process of health food filing, including the online steps of filling out information and generating electronic forms on CFDA’s website, and the offline steps of submitting hardcopies of filing documents. Information on product formula, technical and manufacturing process, safety and efficacy evaluation material, as well as product label samples, etc. are required in application documents for health food filing, similar as those required for health food registration. However, for those products that comply with certain rules and have proper manufacturing processes, no safety, toxicology or efficacy experimental information is needed. Like the guidance document for health food registration, templates of application forms and samples of specification or experimental reports needed are attached in the end as appendices. Specifically, this rule has a flow chart showing the filing process including CFDA’s timelines.
Final thoughts
In summary, the release of these detailed rules and guidance have elaborated further on what is required for relevant applications by adding more details to the administrative measures (AMHFRF). The dietary supplement/health food industry interested in businesses on the Chinese market anticipates more detailed rules and guidance from CFDA regarding other aspects of health food regulation, and more foreign brands are expected to be enticed to enter the China dietary supplement market in the foreseeable future.
If you need further information or assistance with understanding and interpreting these recently announced rules and guidance from CFDA, please contact Burdock Group (www.burdockgroup.com).
References:
[1] The word Filing has also been translated as Notification in some articles.
[2] The Catalog of Raw Materials for Health Food (the first batch), which exclusively includes vitamins and minerals, was officially announced by CFDA on January 12th, 2017.
[3] Huang, J.H. The Administrative Measures on the Registration and Record Filing of Health Foods is formally promulgated. http://www.kwm.com/en/cn/knowledge/insights/registration-and-record-filing-of-health-foods-measures-20160304 Site last visited: February 24, 2017.
[4] Compared with the second step, this meeting will be entirely focused on the controversial issue(s) that caused disagreements among experts in the second step. This third step has more detailed requirements on the number of experts in different areas (such as safety, efficacy and technical aspects, etc.) that need to be present at the meeting, aimed to solve the issue(s) remained after the second step.
China Food and Drug Administration. Detailed Rules on Health Food Registration Review and Approval Process (2016 Version) (in Chinese). Available at: http://www.sda.gov.cn/WS01/CL0847/166399.html Site last visited: February 23, 2017.
China Food and Drug Administration. Guidance on Health Food Registration Applications (2016 Version) (in Chinese). Available at: http://www.sda.gov.cn/WS01/CL0087/167894.html Site last visited: February 23, 2017.
China Food and Drug Administration. Detailed Rules on Health Food Filing Process (2017 Version) (in Chinese). Available at: http://www.sda.gov.cn/WS01/CL0782/169362.html Site last visited: February 23, 2017.