Another recent development in the ongoing food industry regulatory reform is the announcement to update the current standards for conducting stability testing on Health Foods. In an additional pronouncement the rules underpinning the management of human intervention studies and all clinical studies utilizing human test subjects are also set to change, however the impact of this reform on the food industry is slightly less obvious. Standard protocol dictates that the draft standards are subject to a period of public consultation prior to being enacted.
Stability Testing for Health Foods:
The new standard will impose stricter requirements for physiochemical stability and microbial safety of foods under a broader range of environmental stresses. The new standard is designed to ensure the quality and safety of foodstuffs from a physical, sensory, chemical and biological perspective. The standard will also ensure more accurate reporting of labeling requirements such as shelf life, storage recommendations etc.
Human Intervention Studies:
The Chinese food industry has a number of distinct sectors such as Health Foods which can require clinical verification of safety and efficacy. While the technical requirements and protocols for preclinical testing of substances are clearly laid down in the standards and supporting documents (e.g. The Green Book) that govern these sectors, the standards for actually implementing clinical trials have been unclear. The ambiguity has led to regulatory loopholes in China’s food industry which have undermined the integrity of efficacy testing for bioactive foodstuffs. (https://chemical.chemlinked.com/news/other-news/health-food-advertising-state-disarray).The National Health and Family Planning Commission recently published a draft document blueprinting proposed regulatory reforms of China’s existing GCP management system. The updated standard will harmonize clinical trial SOP’s and ethical requirements with international standards. The new standard will impact the following laws and regulations:
Science and Technology Progress Law
Laws and Regulations for Medical Practitioners
Communicable Disease Prevention Act
Food Safety Law
Medical institution regulations
It is important to note that the regulatory reform will not impact GCP for drugs, biological products, medical devices and diagnostic reagents in clinical trials which will continue to be managed by the CFDA. The NHFPC new standard will have no influence on:
Drug Administration Law
Drug Registration Management Regulations
Supervision and Regulation of Medical Devices
For more information or to request an English translation of this draft standard contact info@chemlinked.com
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